US20160022778A1 - A method for treating tumor by using recombinant interferon with changed spatial configuration - Google Patents

A method for treating tumor by using recombinant interferon with changed spatial configuration Download PDF

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US20160022778A1
US20160022778A1 US14/759,410 US201414759410A US2016022778A1 US 20160022778 A1 US20160022778 A1 US 20160022778A1 US 201414759410 A US201414759410 A US 201414759410A US 2016022778 A1 US2016022778 A1 US 2016022778A1
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recombinant interferon
cancer
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Guangwen Wei
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Superlab Far East Ltd
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Definitions

  • the present invention relates to methods for treating tumors in subjects by using recombinant interferon, and to methods for treating solid tumors, including lung cancers in subjects.
  • the present invention further relates to non-surgical methods for eliminating tumors or reducing the sizes of tumors in subjects, or preventing postoperative tumor recurrence and/or metastases and/or prolonging tumor free survival in subjects by using a recombinant interferon (rSIFN-co) with changed spatial configuration, either alone, or in conjunction with radiotherapy, chemotherapy, and/or anti-tumor drugs such as biological agents, targeted drugs and the like.
  • rSIFN-co recombinant interferon
  • Cancer is one of the major causes of death in people around the world.
  • the total number of cases worldwide continues to increase.
  • WHO world health organization
  • the global cancer deaths will be increased by 45% (from U.S. Pat. No. 7,900,000 to Ser. No. 11/500,000) from 2007 to 2030, and the new cases of cancer will zoom from Ser. No. 11/300,000 in 2007 to Ser. No. 15/500,000 in 2030 in the same period, wherein the incidence rate and the death rate of the lung cancer ranks first in the global malignant tumors.
  • the amount of the worldwide new cases of lung cancer every year is more than 3,000,000 and increases continuously (see Gray, J. et al. Chest, 2007, 132, 56S-68S).
  • the number of deaths caused by lung cancer is more than 1,300,000 around the world every year, which is more than the sum of the number of cancer-related deaths caused by other three common cancers (breast cancer, prostate cancer and colorectal cancer).
  • the classic methods for treating cancer include surgical therapy, radiotherapy and chemotherapy.
  • the surgical therapy is not suitable for all types of solid tumors.
  • the surgical therapy may not eliminate cancer cells thoroughly due to metastatic lesions and the like, so as not to achieve the purpose of cure.
  • Radiotherapy is only suitable for the tumors situated at positions that are sensitive to rays, take muscles as tumor beds and have better blood circulation, and the radiotherapy may accidentally injure normal cells to cause various side effects, so as to affect the quality of life of the patients.
  • the effect of the chemotherapy as the systemic treatment means is determined by the types and the states of cancers. Chemotherapy can suppress the growth and the spread of the cancers more especially, and same with the radiotherapy, the chemotherapy can also accidentally injure normal cells to affect the quality of life of the patients.
  • Surgical therapy can be performed to eliminate tumors, improve the quality of life and provide time for follow-up treatment for some early or medium-term solid tumor patients; but for some advanced patients with metastasized solid tumors, the treatment methods in the prior art are only chemotherapy, radiotherapy or combining the chemotherapy, radiotherapy and other treatment methods when the quality of life is obviously affected and life is even threatened, these treatment methods are not ideal in effects and cannot achieve the purpose of eliminating the tumors and completely alleviating the condition of the patients.
  • the biotherapy has become the important treatment means for cancer treatment after surgical therapy, radiotherapy and chemotherapy has been performed.
  • Interferon is a kind of soluble protein produced by a variety of cells which has many important biological functions, including anti-viral, anti-tumor, and immunoregulatory functions. Interferons can be divided into type I, type II, and type III interferons according to the differences in the types of producing cells, receptors and biological activities, etc. Type I IFNs, which are mostly induced by viruses and synthetic double-stranded RNA, are also known as anti-viral interferons. There are three forms of type I interferons: interferon-alpha or alpha-interferon (IFN ⁇ ), interferon-beta (INF ⁇ ) and interferon omega (IFN ⁇ ).
  • IFN ⁇ interferon-alpha or alpha-interferon
  • IFN ⁇ interferon-beta
  • IFN ⁇ interferon omega
  • the amino acid sequence of a protein can determine the three-dimensional structure of the protein and further determine the functionality thereof.
  • synonymous mutation(s) of the nucleotide sequence encoding the protein that is, codon mutation(s) with no change in the amino acid sequence of the encoded protein
  • the nucleotide sequence with synonymous mutation(s) can express and generate proteins with different final spatial structure and different function compared with the wild type protein (see Sarfaty, C. K. et al. Science, 2007, 315:525-528).
  • rSIFN-co recombinant interferon
  • This recombinant interferon, rSIFN-co has the same amino acid sequence as that of INFERGEN®, but the encoding nucleotide sequences of this recombinant interferon, rSIFN-co, and that of INFERGEN® are different (i.e. synonymous mutations exists in the nucleotide sequence encoding the recombinant interferon, rSIFN-co), resulting in changes in spatial configuration of the recombinant interferon, rSIFN-co, and qualitative changes in its biological efficacy.
  • One of the objects of the present invention is to provide new methods for treating tumors in subjects by using the recombinant interferon, rSIFN-co encoded by the nucleotide sequence of SEQ ID NO: 2.
  • Another one of the objects of the present invention is to provide new methods for treating lung cancers in subjects by using the recombinant interferon encoded by the nucleotide sequence of SEQ ID NO: 2 (hereafter also be referred to as recombinant super-compound interferon or rSIFN-co).
  • the present invention provides:
  • a method for treating a tumor in a subject comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the solid tumor comprises one or more of: lung cancer, liver cancer, hepatocellular carcinoma (HCC), esophageal cancer, cholangiocarcinoma, gallbladder carcinoma, stomach cancer, abdominal cancer, gastrointestinal cancer, gastric cancer, pancreatic cancer, renal cell carcinoma, renal cancer, bone cancer, breast cancer, ovarian cancer, uterine cancer, cervical cancer, endometrial cancer, colorectal cancer, colon cancer, rectal cancer, bladder cancer, superficial bladder cancer, prostate cancer, adrenal tumors, squamous cell carcinoma, neuroma, malignant neuroma, myoepithelial carcinoma, synovial sarcoma, rhabdomyosarcoma, gastrointestinal interstitial cell tumor, skin cancer, basal cell carcinoma, malignant melanoma, thyroid cancer, nasopharyngeal carcinoma, hemangioma, epidermoid carcinoma, head and neck cancer, glioma, or Kaposi's sarcoma.
  • lung cancer liver cancer
  • the solid tumor comprises lung cancer
  • the lung cancer comprises small cell lung cancer (SCLC), non small cell lung cancer (NSCLC), or both.
  • SCLC small cell lung cancer
  • NSCLC non small cell lung cancer
  • non-solid tumor comprises one or more of: leukemia, acute leukemia, chronic leukemia, chronic myelocytic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, acute lymphoblastic leukemia, T-cell leukemia, hairy cell leukemia, polycythemia, myelodysplastic syndrome, multiple myeloma, lymphadenoma, Hodgkin's lymphoma, and Non-Hodgkin's lymphoma.
  • the administration route comprises one or more of: oral, rectal, sublingual, intravenous, intra-arterial, intramuscular, subcutaneous, intra-bone, intracutaneous, intra-articular, intraperitoneal, intrathecal, intracerebral, vaginal, percutaneous, transdermal, epidermal, transmucosal, transocular, pulmonary, nasal, abdominal, intrapleural, intraventricular, pericardial, inhalation, intratumoral, uterine, infiltration, and intravesical administration.
  • the duration of the treatment cycle is at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like, or optionally, the recombinant interferon can be administered for a long time, including over the life time of the subject; or the duration of recombinant interferon treatment can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about 9 months and the like.
  • time interval between any two adjacent treatment cycles of the more treatment cycles is at least about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like; or optionally the time interval can be about 2 days to about 6 years, about 4 days to about 3 years, about 1 week to about 1 year, about 2 months to about 9 months, or about 3 months to about 6 months and the like.
  • chemotherapeutic drugs used in the first-line chemotherapy comprise platinum compounds, such as Cisplatin.
  • a method for treating tumor in a subject comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2, and at least one other anti-cancer therapy, wherein the at least one other anti-cancer therapy is administered to the subject before, simultaneously, and/or after administration of the recombinant interferon, and wherein the tumor is a cancer or solid tumor that is not indicated nor appropriate for surgery, or the tumor is a solid tumor that cannot be resected, and the combination of the recombinant interferon and the at least one other anti-cancer therapy eliminate the tumor or reduce the size of the tumor compared to the tumor before treatment.
  • another embodiment of the present invention provides:
  • a method for preventing tumor recurrence and/or metastasis or prolonging or maintaining a tumor-free status in a subject with a tumor after at least one anti-cancer therapy comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the solid tumor comprises one or more of: lung cancer, liver cancer, hepatocellular carcinoma (HCC), esophageal cancer, cholangiocarcinoma, gallbladder carcinoma, stomach cancer, abdominal cancer, gastrointestinal cancer, gastric cancer, pancreatic cancer, renal cell carcinoma, renal cancer, bone cancer, breast cancer, ovarian cancer, uterine cancer, cervical cancer, endometrial cancer, colorectal cancer, colon cancer, rectal cancer, bladder cancer, superficial bladder cancer, prostate cancer, adrenal tumors, squamous cell carcinoma, neuroma, malignant neuroma, myoepithelial carcinoma, synovial sarcoma, rhabdomyosarcoma, gastrointestinal interstitial cell tumor, skin cancer, basal cell carcinoma, malignant melanoma, thyroid cancer, nasopharyngeal carcinoma, hemangioma, epidermoid carcinoma, head and neck cancer, glioma, or Kaposi's sarcoma.
  • lung cancer liver cancer
  • the solid tumor comprises lung cancer
  • the lung cancer comprises small cell lung cancer (SCLC), non small cell lung cancer (NSCLC), or both.
  • SCLC small cell lung cancer
  • NSCLC non small cell lung cancer
  • non-solid tumor comprises one or more of: leukemia, acute leukemia, chronic leukemia, chronic myelocytic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, acute lymphoblastic leukemia, T-cell leukemia, hairy cell leukemia, polycythemia, myelodysplastic syndrome, multiple myeloma, lymphadenoma, Hodgkin's lymphoma, and Non-Hodgkin's lymphoma.
  • the administration route comprises one or more of: oral, rectal, sublingual, intravenous, intra-arterial, intramuscular, subcutaneous, intra-bone, intracutaneous, intra-articular, intraperitoneal, intrathecal, intracerebral, vaginal, percutaneous, transdermal, epidermal, transmucosal, transocular, pulmonary, nasal, abdominal, intrapleural, intraventricular, pericardial, inhalation, intratumoral, uterine, infiltration, and intravesical administration.
  • each prevention cycle is at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject; or the duration can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about 9 months and the like.
  • time interval between any two adjacent prevention cycles of the more prevention cycles is at least about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like; or the time interval can also be about 2 days to about 6 years, about 4 days to about 3 years, about 1 week to about 1 year, about 2 months to about 9 months, or about 3 months to about 6 months and the like.
  • the at least one anti-cancer therapy comprises at least one of: chemotherapy, radiotherapy, surgical therapy, interventional therapy, biotherapy, gene therapy, ablation therapy, immunotherapy, targeted therapy, and traditional Chinese medicine therapy
  • the at least one anti-cancer therapy comprises at least one of: chemotherapy, radiotherapy, surgical therapy, and biotherapy.
  • the administration route comprises one or more of: infiltration administration, intrapleural administration, abdominal administration, pericardial administration, uterine administration, intravesical administration, intratumoral administration, pulmonary administration, nasal administration, percutaneous administration, transdermal administration, epidermal administration, and transmucosal administration.
  • another embodiment of the present invention provides:
  • a non-surgical method for eliminating a tumor in a subject or reducing the size of a tumor in a subject comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the solid tumor comprises one or more of: lung cancer, liver cancer, hepatocellular carcinoma (HCC), esophageal cancer, cholangiocarcinoma, gallbladder carcinoma, stomach cancer, abdominal cancer, gastrointestinal cancer, gastric cancer, pancreatic cancer, renal cell carcinoma, renal cancer, bone cancer, breast cancer, ovarian cancer, uterine cancer, cervical cancer, endometrial cancer, colorectal cancer, colon cancer, rectal cancer, bladder cancer, superficial bladder cancer, prostate cancer, adrenal tumors, squamous cell carcinoma, neuroma, malignant neuroma, myoepithelial carcinoma, synovial sarcoma, rhabdomyosarcoma, gastrointestinal interstitial cell tumor, skin cancer, basal cell carcinoma, malignant melanoma, thyroid cancer, nasopharyngeal carcinoma, hemangioma, epidermoid carcinoma, head and neck cancer, glioma, or Kaposi's sarcoma.
  • lung cancer liver cancer
  • the solid tumor comprises lung cancer
  • the lung cancer comprises small cell lung cancer (SCLC), non small cell lung cancer (NSCLC), or both.
  • SCLC small cell lung cancer
  • NSCLC non small cell lung cancer
  • the administration route comprises one or more of: infiltration administration, intrapleural administration, abdominal administration, pericardial administration, uterine administration, intravesical administration, intratumoral administration, pulmonary administration, nasal administration, percutaneous administration, transdermal administration, epidermal administration, and transmucosal administration.
  • another embodiment of the present invention provides:
  • a method for eliminating or reducing the pleural effusion, ascites, and/or pericardial effusion in a subject with tumor comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the solid tumor comprises one or more of: lung cancer, liver cancer, hepatocellular carcinoma (HCC), esophageal cancer, cholangiocarcinoma, gallbladder carcinoma, stomach cancer, abdominal cancer, gastrointestinal cancer, gastric cancer, pancreatic cancer, renal cell carcinoma, renal cancer, bone cancer, breast cancer, ovarian cancer, uterine cancer, cervical cancer, endometrial cancer, colorectal cancer, colon cancer, rectal cancer, bladder cancer, superficial bladder cancer, prostate cancer, adrenal tumors, squamous cell carcinoma, neuroma, malignant neuroma, myoepithelial carcinoma, synovial sarcoma, rhabdomyosarcoma, gastrointestinal interstitial cell tumor, skin cancer, basal cell carcinoma, malignant melanoma, thyroid cancer, nasopharyngeal carcinoma, hemangioma, epidermoid carcinoma, head and neck cancer, glioma, or Kaposi's sarcoma.
  • lung cancer liver cancer
  • the solid tumor comprises lung cancer
  • the lung cancer comprises small cell lung cancer (SCLC), non small cell lung cancer (NSCLC), or both.
  • SCLC small cell lung cancer
  • NSCLC non small cell lung cancer
  • the administration route comprises one or more of: infiltration administration, intrapleural administration, abdominal administration, and pericardial administration.
  • At least one targeted drug comprises at least one of: Gefitinib, Erlotinib, and recombinant human endostatin.
  • another embodiment of the present invention provides:
  • a method for treating tumor in a subject comprising topically or locally administering to the tumor lesions of the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • a method for eliminating or reducing metastatic tumor lesions in a subject comprising topically or locally administering to the metastatic tumor lesions of the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • tumor lesions comprise at least one of: bone lesions, muscular lesions, subcutaneous tissue lesions, prostatic lesions and lymph node lesions
  • tumor metastatic lesions comprise at least one of: bone metastatic lesions, muscular metastatic lesions, subcutaneous tissue metastatic lesions, prostatic metastatic lesions, and lymph node metastatic lesions
  • the tumor metastatic lesions comprise bone metastatic lesions.
  • topical or local administration comprises at least one of: infiltration administration, percutaneous administration, transdermal administration, epidermal administration and transmucosal administration, optionally, the topical and local administration comprises transdermal administration, or infiltration administration.
  • infiltration administration comprises one or more of: percutaneous infiltration administration, epidermal infiltration administration, transdermal infiltration administration, and transmucosal infiltration administration.
  • percutaneous administration, transdermal administration, epidermal administration, or transmucosal administration comprises percutaneous spray administration, transdermal spray administration, epidermal spray administration, or transmucosal spray administration, respectively.
  • (22) The method of any one of (18)-(21), wherein the duration of administration of induction dose and therapeutic dose is at least: about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject.
  • a method for eliminating or reducing the bone metastatic lesions of tumor in a subject comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 by topical or local administration, wherein the topical or local administration comprises transdermal administration and/or infiltration administration, optionally, the recombinant interferon is administered to the bone metastatic lesions of tumor of the subject.
  • a method for eliminating or reducing the bone lesions of tumor such as bone metastatic lesions of tumor, muscular lesions of tumor such as muscular metastatic lesions of tumor, subcutaneous tissue lesions of tumor such as subcutaneous tissue metastatic lesions of tumor, prostatic lesions of tumor such as prostatic metastatic lesions of tumor, and/or lymph node lesions of tumor such as lymph node metastatic lesions of tumor in a subject, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 by any administration route through the skin, so that eliminating or reducing the bone lesions of tumor such as bone metastatic lesions of tumor, muscular lesions of tumor such as muscular metastatic lesions of tumor, subcutaneous tissue lesions of tumor such as subcutaneous tissue metastatic lesions of tumor, prostatic lesions of tumor such as prostatic metastatic lesions of tumor, and/or lymph node lesions of tumor such as lymph node metastatic lesions of tumor, optionally, the recombinant interferon is administered to the metastatic lesions of tumor of the
  • another embodiment of the present invention provides:
  • a method for treating lung cancer in a subject comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • lung cancer comprises small cell lung cancer (SCLC), non small cell lung cancer (NSCLC), or both.
  • SCLC small cell lung cancer
  • NSCLC non small cell lung cancer
  • the administration route comprises one or more of: oral, rectal, sublingual, intravenous, intra-arterial, intramuscular, subcutaneous, intra-bone, intracutaneous, intra-articular, intraperitoneal, intrathecal, intracerebral, vaginal, percutaneous, transdermal, epidermal, transmucosal, transocular, pulmonary, nasal, abdominal, intrapleural, intraventricular, pericardial, inhalation, intratumoral, uterine, infiltration, and intravesical administration.
  • lung cancer in the subject comprises tumor metastasis in at least one of: skin, mucosa, superficial lymph nodes, and subcutaneous tissue.
  • spray administration comprises at least one of: percutaneous spray administration, transdermal spray administration, epidermal spray administration, and transmucosal spray administration.
  • the administration route comprises at least one of: subcutaneous administration, intramuscular administration, inhalation administration, infiltration administration, intrapleural administration, abdominal administration, pericardial administration, intratumoral administration, and spray administration.
  • the method of (54), wherein the at least one other anti-cancer therapy comprises at least one of: chemotherapy, radiotherapy, surgical therapy, interventional therapy, biotherapy, gene therapy, ablation therapy, immunotherapy, targeted therapy, and traditional Chinese medicine therapy.
  • duration of the treatment cycle is at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject; or the duration can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about 9 months and the like.
  • time interval between any two adjacent treatment cycles of the more treatment cycles is at least about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like; or the time interval can also be about 2 days to about 6 years, about 4 days to about 3 years, about 1 week to about 1 year, about 2 months to about 9 months, or about 3 months to about 6 months and the like.
  • a method for treating lung cancer in a subject comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 and one or more chemotherapeutic drugs in two or more treatment cycles, and then administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 and one or more targeted drugs in one or more treatment cycles.
  • another embodiment of the present invention provides:
  • a method for treating lung cancer in a subject comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 by subcutaneous administration and/or intramuscular administration, wherein the recombinant interferon is administered in an amount in a range of about 2 ⁇ g to about 70 ⁇ g, optionally about 4 ⁇ g to about 50 ⁇ g, further optionally about 4 ⁇ g to about 30 ⁇ g by one subcutaneous administration and/or intramuscular administration, the recombinant interferon is administered by subcutaneous administration and/or intramuscular administration once every about 1 to about 7 days, optionally every about 1 to about 2 days, lasting at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months
  • lung cancer comprises small cell lung cancer (SCLC), non small cell lung cancer (NSCLC), or both.
  • SCLC small cell lung cancer
  • NSCLC non small cell lung cancer
  • lung cancer in the subject comprises tumor metastasis in at least one of: skin, mucosa, superficial lymph nodes, and subcutaneous tissue.
  • spray administration comprises at least one of: percutaneous spray administration, transdermal spray administration, epidermal spray administration, and transmucosal spray administration.
  • the method of (40), wherein the at least one other anti-cancer therapy comprises one or more of: chemotherapy, radiotherapy, surgical therapy, interventional therapy, biotherapy, gene therapy, ablation therapy, immunotherapy, targeted therapy, and traditional Chinese medicine therapy.
  • another embodiment of the present invention provides:
  • a method for treating lung cancer in a subject comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 by subcutaneous administration and/or intramuscular administration, wherein the recombinant interferon is administered one or more times by subcutaneous administration and/or intramuscular administration at an induction dose in a range of about 2 ⁇ g to about 10 ⁇ g each time, optionally about 4 ⁇ g to about 10 ⁇ g each time, further optionally about 4.5 ⁇ g to about 9 ⁇ g each time, such as about 4.5 ⁇ g each time or about 9 ⁇ g each time, and then the recombinant interferon is administered more times by subcutaneous administration and/or intramuscular administration at a therapeutic dose in a range of about 10 ⁇ g to about 70 ⁇ g each time, optionally about 12 ⁇ g to about 50 ⁇ g each time, further optionally about 12 ⁇ g to about 30 ⁇ g each time.
  • lung cancer comprises small cell lung cancer (SCLC), non small cell lung cancer (NSCLC), or both.
  • SCLC small cell lung cancer
  • NSCLC non small cell lung cancer
  • time interval between administration of induction dose and administration of therapeutic dose is about 1 day to about 1 month, optionally about 1 day to about 1 week, further optionally about 1 day to about 3 days, comprising such as about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, or about 1 month.
  • the recombinant interferon is administered once every about 1 day to about 10 days, optionally every about 1 day to about 7 days, further optionally every about 1 to about 2 days, comprising such as every about 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 days when the recombinant interferon is administered more times at an induction dose.
  • the administration route comprises at least one of: intrapleural administration, abdominal administration, and pericardial administration.
  • lung cancer in the subject comprises tumor metastasis in at least one of: skin, mucosa, superficial lymph nodes, and subcutaneous tissue.
  • another embodiment of the present invention provides:
  • a method for treating cancer in a subject, wherein the cancer originates from lung cancer in the subject and metastasizes to brain comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2, wherein the recombinant interferon is administered one or more times by subcutaneous administration and/or intramuscular administration at an induction dose in a range of about 2 ⁇ g to about 10 ⁇ g each time, optionally about 4 ⁇ g to about 10 ⁇ g each time, further optionally about 4.5 ⁇ g to about 9 ⁇ g each time, such as about 4.5 ⁇ g each time or about 9 ⁇ g each time, and then the recombinant interferon is administered more times by subcutaneous administration and/or intramuscular administration at a therapeutic dose in a range of about 10 ⁇ g to about 70 ⁇ g each time, optionally about 12 ⁇ g to about 50 ⁇ g each time, further optionally about 12 ⁇ g to about 30 ⁇ g each time, and the recombinant interferon
  • (10) The method of any one of (1)-(9), wherein the time interval between administration of induction dose and administration of therapeutic dose is about 1 day to about 1 month, optionally about 1 day to about 1 week, further optionally about 1 day to about 3 days, comprising such as about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, or about 1 month.
  • duration of the inhalation administration is at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject; or the duration can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about 9 months and the like.
  • another embodiment of the present invention provides:
  • a method for treating cancer in a subject comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2, wherein the recombinant interferon is administered one or more times by subcutaneous administration and/or intramuscular administration at an induction dose in a range of about 2 ⁇ g to about 10 ⁇ g each time, optionally about 4 ⁇ g to about 10 ⁇ g each time, further optionally about 4.5 ⁇ g to about 9 ⁇ g each time, such as about 4.5 ⁇ g each time or about 9 ⁇ g each time, and then the recombinant interferon is administered more times by subcutaneous administration and/or intramuscular administration at a therapeutic dose of about 10 ⁇ g-about 70 ⁇ g each time, optionally about 12 ⁇ g to about 50 ⁇ g each time, further optionally about 12 ⁇ g to about 30 ⁇ g each time.
  • time interval between administration of induction dose and administration of therapeutic dose is about 1 day to about 1 month, optionally about 1 day to about 1 week, further optionally about 1 day to about 3 days, comprising such as about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, or about 1 month.
  • (11) The method of any one of (1)-(10), wherein the duration of administration of induction dose and therapeutic dose is at least about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject.
  • the recombinant interferon is administered in an amount in a range of about 100 ⁇ g to about 2000 ⁇ g, optionally about 100 ⁇ g to about 1500 ⁇ g, further optionally about 150 ⁇ g to about 800 ⁇ g, still further optionally about 200 ⁇ g to about 600 ⁇ g by one inhalation administration, the recombinant interferon is administered by inhalation administration once every about 1 day to about 3 days, optionally every about 1 day, and the duration of the inhalation administration is at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years,
  • the at least one other anti-cancer therapy comprises one or more of: chemotherapy, radiotherapy, surgical therapy, interventional therapy, biotherapy, gene therapy, ablation therapy, immunotherapy, targeted therapy, and traditional Chinese medicine therapy.
  • another embodiment of the present invention provides:
  • a method for treating cancer in a subject, wherein the cancer originates from lung cancer in the subject and metastasizes to lymph nodes comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2, wherein the recombinant interferon is administered one or more times by subcutaneous administration and/or intramuscular administration at an induction dose in a range of about 2 ⁇ g to about 10 ⁇ g each time, optionally about 4 ⁇ g to about 10 ⁇ g each time, further optionally about 4.5 ⁇ g to about 9 ⁇ g each time, such as about 4.5 ⁇ g each time or about 9 ⁇ g each time, and then the recombinant interferon is administered more times by subcutaneous administration and/or intramuscular administration at a therapeutic dose of about 10 ⁇ g to about 70 ⁇ g each time, optionally about 12 ⁇ g to about 50 ⁇ g each time, further optionally about 12 ⁇ g to about 30 ⁇ g each time, and the recombinant interferon is administered
  • time interval between administration of induction dose and administration of therapeutic dose is about 1 day to about 1 month, optionally about 1 day to about 1 week, further optionally about 1 day to about 3 days, comprising such as about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, or about 1 month.
  • (11) The method of any one of (1)-(10), wherein the duration of administration of induction dose and therapeutic dose is at least about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject.
  • topical or local administration comprises at least one of: infiltration administration, percutaneous administration, transdermal administration, epidermal administration, and transmucosal administration when the lymph nodes are superficial lymph nodes.
  • another embodiment of the present invention provides:
  • a method for treating lung cancer in a subject, wherein the subject has pleural effusion, ascites and/or pericardial effusion comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 by topical or local administration.
  • pleural effusion is a malignant pleural effusion
  • ascites is a malignant ascites
  • pericardial effusion is a malignant pericardial effusion
  • the local administration comprises at least one of: infiltration administration, intrapleural administration, abdominal administration, and pericardial administration.
  • duration of administration of induction dose and therapeutic dose is at least about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject.
  • the tumor is a solid tumor; optionally, the solid tumor comprises one or more of: lung cancer, liver cancer, hepatocellular carcinoma (HCC), esophageal cancer, cholangiocarcinoma, gallbladder carcinoma, stomach cancer, abdominal cancer, gastrointestinal cancer, gastric cancer, pancreatic cancer, renal cell carcinoma, renal cancer, bone cancer, breast cancer, ovarian cancer, uterine cancer, cervical cancer, endometrial cancer, colorectal cancer, colon cancer, rectal cancer, bladder cancer, superficial bladder cancer, prostate cancer, adrenal tumors, squamous cell carcinoma, neuroma, malignant neuroma, myoepithelial carcinoma, synovial sarcoma, rhabdomyosarcoma, gastrointestinal interstitial cell tumor, skin cancer, basal cell carcinoma, malignant melanoma, thyroid cancer, nasopharyngeal carcinoma, hemangioma, epidermoid carcinoma, head
  • the tumor is a tumor such as cancer or solid tumor without indications for surgery or not indicated or appropriate for surgery; and/or the subject is a medium-term, advanced cancer patient, or III or IV stage cancer patient, optionally, the subject is an advanced, or III or IV stage cancer patient.
  • the recombinant interferon is administered to the subject as monotherapy; or, further comprising one or more other anti-cancer therapies administered to the subject, optionally, other anti-cancer therapies are administered to the subject before, simultaneously, and/or after administration of the recombinant interferon.
  • the other anti-cancer therapies comprise one or more of: chemotherapy, radiotherapy, surgical therapy, interventional therapy, biotherapy, gene therapy, ablation therapy, immunotherapy, targeted therapy, and traditional Chinese medicine therapy.
  • another embodiment of the present invention also provides:
  • a method of treating a tumor in a subject comprising administering to the subject a recombinant interferon that comprises an anti-tumor effect as a first line monotherapy.
  • the tumor comprises one of: lung cancer, uterine cancer, cervical cancer, and pancreatic cancer.
  • a method of treating a tumor in a subject comprising administering to the subject a recombinant interferon that comprises an antitumor effect as a second line monotherapy.
  • the tumor comprises one of: lung cancer, colorectal cancer, malignant melanoma, ovarian cancer, cervical cancer, liver cancer, breast cancer, gastrointestinal cancer, prostate cancer, neuroma, and squamous cell carcinoma.
  • liver cancer comprises HCC.
  • a method of treating a tumor in a subject comprising administering to the subject a recombinant interferon that comprises an anti-tumor effect as a first line therapy in combination with one or more other anti-cancer therapy.
  • lung cancer comprises at least one of non-small cell lung cancer and small cell lung cancer.
  • a method of treating a tumor in a subject comprising administering to the subject a recombinant interferon that comprises an anti-tumor effect as a second line therapy in combination with one or more other anti-cancer therapies.
  • tumor comprises one of: lung cancer, lymphoma, cervical cancer, and cholangioadenocarcinoma.
  • lung cancer comprises at least one of non-small cell lung cancer and small cell lung cancer.
  • lymphoma is non-Hodgkins lymphoma.
  • a method of preventing tumor recurrence in a subject comprising administering an amount of a recombinant interferon that comprises an amino acid sequence that is encoded by a nucleic acid sequence comprising the sequence of SEQ ID NO: 2 after surgery, chemotherapy, radiotherapy, cryoablation, radiofrequency ablation, biologics therapy, intervention therapy, and/or rSIFN-co therapy, whereby the recombinant interferon is administered after tumor bulk in the subject has been reduced.
  • a method of prolonging tumor-free survival in a subject comprising administering an amount of a recombinant interferon that comprises an amino acid sequence that is encoded by a nucleic acid sequence comprising the sequence of SEQ ID NO: 2 after surgery, chemotherapy, radiotherapy, cryoablation, radiofrequency ablation, biologics therapy, intervention therapy, and/or rSIFN-co therapy, whereby the recombinant interferon is administered after tumor bulk in the subject has been reduced.
  • FIG. 1 shows the comparative difference in the structures of the present recombinant interferon (rSIFN-co) and IFN- ⁇ 2b, wherein in a side view and a top view in the FIG. 1 , the red shows rSIFN-co, the green shows IFN- ⁇ 2b, the red is black in a black and white print drawing, and the green is grey in the black and white print drawing.
  • rSIFN-co present recombinant interferon
  • FIG. 2 shows the comparative difference of the three-dimensional structure of the recombinant interferon rSIFN-co of the present invention and the computation model structure of INFERGEN® (being indicated as am-Infergen or Infergen) of the US Amgen, wherein in a circle in the right drawing, a thin line in yellow is rSIFN-co, and a thick spiral in blue is am-Infergen. Meanwhile, in the right drawing, the red shows rSIFN-co, and the green shows am-Infergen, wherein the red is black in the black and white print drawing, and the green is grey in the black and white print drawing.
  • FIGS. 3 a - 3 b shows the treatment situation of patient 1, wherein an arrow in FIG. 3 a shows state of the original lesion observed in a CT image on 8 th November, Year 2, after 12 months of medication; and an arrow in FIG. 3 b shows state of the original lesion observed in a CT image on 1 st February, Year 3, after 15 months of medication, the year of the start of treatment being Year 1.
  • FIGS. 4 a - 4 b shows the treatment situation of patient 2, wherein FIG. 4 a shows a PET/CT imaging diagnosis before rSIFN-co medication, and an arrow indicates the lesion; and FIG. 4 b shows a PET/CT imaging diagnosis after rSIFN-co medication, and an arrow indicates the state of the original lesion after treatment.
  • FIGS. 5 a - 5 b and 6 a - 6 b show the treatment situation of patient 3, wherein FIG. 5 a shows a lung CT image before rSIFN-co medication, and an arrow indicates the lesion; FIG. 5 b shows head and chest CT imaging diagnoses after rSIFN-co medication, and an arrow indicates the state of the original lesion after treatment; FIG. 6 a shows a brain CT image before rSIFN-co medication, and an arrow indicates the lesion; and FIG. 6 b shows head and chest imaging diagnoses after rSIFN-co medication, and an arrow indicates the state of the original lesion after treatment.
  • FIGS. 7 a - 7 b and FIGS. 8 a - 8 b show the treatment situation of patient 4, wherein FIGS. 7 a and 8 a show imaging diagnoses before rSIFN-co medication: as shown in PET/CT after chemotherapy, arrows in the FIGS. 7 a and 8 a indicate the lesions; and FIGS. 7 b and 8 b show imaging diagnoses after rSIFN-co medication: as shown in PET/CT, an arrow indicates the state of the original lesion after treatment.
  • FIGS. 9 a - 9 b , 10 a - 10 b and 11 a - 11 b show the treatment situation of patient 5, wherein FIGS. 9 a , 10 a and 11 a show imaging diagnoses before rSIFN-co medication: as shown in PET/CT, and arrows in the FIGS. 9 a , 10 a and 11 a show the lesions; and FIGS. 9 b , 10 b and 11 b show imaging diagnoses after rSIFN-co medication: as shown in PET/CT, and arrows in the FIGS. 9 b , 10 b and 11 b show the states of the original lesions after treatment.
  • FIGS. 12 a - 12 b shows the treatment situation of patient 6, wherein FIG. 12 a shows a chest CT imaging diagnosis before rSIFN-co medication, and an arrow shows the original lesion; and FIG. 12 b shows a CT imaging diagnosis after rSIFN-co medication, and an arrow shows the state of the original lesion after treatment.
  • FIGS. 13 a - 13 b and 14 a - 14 b show the treatment situation of patient 7, wherein FIGS. 13 a and 14 a show CT imaging diagnoses before rSIFN-co medication, and arrows show the original lesions; and FIGS. 13 b and 14 b show CT imaging diagnoses after rSIFN-co medication, and arrows show the states of the original lesions after treatment.
  • FIGS. 15 a - 15 b and 16 a - 16 b show the treatment situation of patient 8, wherein FIGS. 15 a and 16 a show CT imaging diagnoses before rSIFN-co medication, and arrows show the original lesions; and FIGS. 15 b and 16 b show CT imaging diagnoses after rSIFN-co medication, and arrows show the states of the original lesions after treatment.
  • FIGS. 171-17 b shows the treatment situation of patient 9, wherein FIG. 17 a shows a CT imaging diagnosis before rSIFN-co medication, and an arrow shows the original lesion; and FIG. 17 b shows a CT imaging diagnosis after rSIFN-co medication, and an arrow shows the state of the original lesion after treatment.
  • FIGS. 18 and 19 a - 19 b show the treatment situation of patient 10, wherein the FIG. 18 shows pleural effusion change before and after the treatment;
  • FIG. 19 a shows a chest CT imaging diagnosis before rSIFN-co medication, and an arrow shows the original lesion;
  • FIG. 19 b shows a chest CT imaging diagnosis after rSIFN-co medication, and an arrow shows the state of the original lesion after treatment.
  • FIGS. 20 , 21 a - 21 b , 22 a - 22 b and 23 a - 23 b show the treatment situation of patient 11, wherein FIG. 20 shows the biopsy of patient before treatment, FIGS. 21 a , 22 a and 23 a show PET/CT imaging diagnoses before rSIFN-co medication, and arrows show the original lesions; and FIGS. 21 b , 22 b and 23 b show PET/CT imaging diagnoses after rSIFN-co medication, and arrows show the states of the original lesions after treatment.
  • FIGS. 24 a - 24 b shows the treatment situation of patient 12, wherein FIG. 24 a shows a CT image at the beginning of the medicine administration, and an arrow shows the original lesion; and FIG. 24 b shows an imaging diagnosis after rSIFN-co medication, and an arrow shows the state of the original lesion after treatment.
  • FIGS. 25 a - 25 b shows the treatment situation of patient 13, wherein FIG. 25 a shows a CT image at the early stage of the treatment, and an arrow shows suspicious lesions of inferior lobe of right lung; and FIG. 25 b shows a chest CT image at the later stage of the treatment, and an arrow shows the state of original suspicious lesions of inferior lobe of right lung after treatment.
  • FIGS. 26 a - 26 b shows the treatment situation of patient 14, wherein FIG. 26 a shows a CT image at the beginning of the medicine administration (after surgery), and an arrow shows the original lesion; and FIG. 26 b shows a CT image at the later stage of the treatment, and an arrow shows the state of the original lesion after treatment.
  • FIGS. 27 a - 27 b shows the treatment situation of patient 15, wherein FIG. 27 a shows a pelvic cavity MRI imaging diagnosis before rSIFN-co medication, and an arrow shows the original lesion; and FIG. 27 b shows a pelvic cavity MRI imaging diagnosis after rSIFN-co medication, and an arrow shows the state of the original lesion after treatment.
  • FIG. 28 shows a pathological diagnosis of patient 16, and an arrow shows adenocarcinoma cells.
  • FIGS. 29 a - 29 b shows the treatment situation of the patient 16, wherein FIG. 29 a shows a PEC/CT imaging diagnosis before rSIFN-co medication, and an arrow shows the original lesion; and FIG. 29 b shows a PEC/CT imaging diagnosis after rSIFN-co medication, and an arrow show the state of the original lesion after treatment.
  • rSIFN-co can be advantageously used to control cancer, either alone or in combination with other anti-cancer therapies, as a first line or second line monotherapy or in combination with other treatment modalities.
  • the advantages are: Firstly, the recombinant interferon (rSIFN-co) has broad-spectrum anti-tumor effects, which is effective to treat both solid tumors and non-solid tumors. At the same time, rSIFN-co has good synergetic effect with existing treatment means such as surgical therapy, chemotherapy, radiotherapy, other biotherapies and other anti-tumor drugs.
  • rSIFN-co has low toxicity, which means that little or no harm to normal cells has been observed when rSIFN-co is used in large doses.
  • rSIFN-co is convenient to use and can be directly applied to tumors located in any part of the body.
  • rSIFN-co can be used by subcutaneous or intramuscular injection to control systemic progression of tumor, by intrapleural or abdominal perfusion to eliminate effusion and intrapleural or abdominal tumors, by topical or local injection to eliminate primary or metastatic tumors, and by infiltration (transdermal) administration to treat tumor lesions in bone, skin, muscle, prostate and the like.
  • rSIFN-co can be administered by aerosol inhalation or by nasal spray.
  • rSIFN-co its effective rate on tumors, as a monotherapy and as one element of a combination therapy, is not lower than 90%.
  • rSIFN-co can be used after surgery in place of chemotherapy and effectively prevent recurrence and tumor metastasis or prolong the period of disease-free survival; with regard to advanced cancer cases or cancer cases that are not indicated for surgery, rSIFN-co can be used to eliminate or reduce the size of tumors without surgery; with regard to tumors that are not indicated for surgery, rSIFN-co can be used to transform the tumors into ones for which surgery is possible, that is, turning a non-resectable tumor into a resectable tumor, thereby creating conditions appropriate for surgery. Therefore, rSIFN-co, alone or in combination with other one or more anti-tumor therapy, is capable of controlling cancer in a large number of instances.
  • amino acid sequence of the present recombinant interferon as well as the nucleotide sequence encoding the same (together with a termination codon), are shown below as SEQ ID NO:1 and SEQ ID NO:2, respectively. These sequences are also referenced in U.S. Pat. Nos. 7,585,647; 7,364,724; 8,114,395 and 8,287,852:
  • interferon alfacon-1 interferon alfacon-1
  • rSIFN-co interferon alfacon-1
  • the red represents rSIFN-co
  • the green represents IFN- ⁇ 2b
  • the red is black in the black-and-white print drawing
  • the green is grey in the black-and-white print drawing
  • the computation model structure of the interferon alfacon-1 see KORN, A P, Journal of Interferon Research 1994, 14:1-9.
  • the present recombinant interferon is more effective than any interferon used clinically at present (including interferon alfacon-1 (INFERGEN®)).
  • interferon alfacon-1 interferon alfacon-1
  • the present recombinant interferon is capable of not only inhibiting DNA replication of HBV, but also inhibiting secretion of both hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).
  • the efficiency of inhibiting DNA replication of hepatitis B core antigen (HBcAg) by this interferon is about twice that of interferon alfacon-1 (INFERGEN®).
  • the in vitro pharmacodynamics of the present recombinant interferon shows that it is capable of not only inhibiting the DNA replication of HBV, but also inhibiting secretion of both hepatitis B surface antigen and hepatitis B e antigen.
  • the cytotoxicity of the present recombinant interferon is only 1 ⁇ 8 that of the current clinically used interferons, but its antiviral activity is as much as 5-20 times greater; meanwhile, the biological responses of the present recombinant interferon is more effective, more broad-spectrum and longer lasting in the human body (see CN 1740197A).
  • the present recombinant interferon shows higher antiviral activity and less side effects compared with any other interferons (including interferon alfacon-1 (INFERGEN®)).
  • this recombinant interferon possesses not only an antiviral activity 20 times as great as that of the interferons currently in clinical use, but also a more effective inhibiting tumor cell growth or promoting apoptosis function compared with recombinant human interferon ⁇ .
  • the present recombinant interferon has a different spatial configuration, enhanced biologic activities and/or different pharmacokinetics characteristics as compared with the interferon such as interferon alfacon-1 (INFERGEN®), which has the amino acid sequence of SEQ ID NO: 1, but is not encoded by the nucleotide sequence of SEQ ID NO: 2.
  • interferon alfacon-1 IFERGEN®
  • the present recombinant interferon has the amino acid sequence of SEQ ID NO: 1, such as consisting of the amino acid sequence of SEQ ID NO: 1.
  • the present recombinant interferon is encoded by the nucleotide sequence of SEQ ID NO: 2.
  • the present recombinant interferon has the amino acid sequence of SEQ ID NO: 1, and is encoded by the nucleotide sequence of SEQ ID NO: 2.
  • the recombinant interferon comprises the amino acid sequence of SEQ ID NO: 1, and is encoded by the nucleotide sequence of SEQ ID NO: 2.
  • the recombinant interferon is consisted of the amino acid sequence of SEQ ID NO: 1, and is encoded by the nucleotide sequence of SEQ ID NO: 2.
  • the present recombinant interferon in comparison with interferon such as interferon alfacon-1 (INFERGEN®), which has the amino acid sequence of SEQ ID NO: 1, but is not encoded by the nucleotide sequence of SEQ ID NO: 2, the present recombinant interferon has a changed spatial configuration and/or enhanced biologic activities and/or different pharmacokinetics characteristics.
  • the present recombinant interferon has a changed spatial configuration and enhanced biologic activities, changed spatial configuration and different pharmacokinetics characteristics, or changed spatial configuration, enhanced biologic activities and different pharmacokinetics characteristics.
  • the enhanced biological activities include: enhanced antiviral activity, enhanced tumor cell growth inhibition or proapoptotic effect, less side effects and/or could be used in large dose (e.g.
  • the enhanced biological activities can be enhanced antiviral activity and/or enhanced tumor cell (such as breast cancer cell or cervical cancer cell) growth inhibition or proapoptotic effect (see Zheng, J. et al. J Sichuan Univ (Med Sci Edi), 2010, 41(1), 29-34; Chen, Y, et al. J Sichuan Univ (Med Sci Edi), 2008, 39(5), 715-718).
  • the different pharmacokinetics characteristics include: after intramuscular injection of the recombinant interferon in subjects whose BMI ranged from about 18 to about 23, the time of blood sample collection was plotted against the concentration of 2-5 A oligonucleotidase in the serum of the subjects, and the resulting area under the curve of this chart is significantly greater and/or the half-life of this recombinant interferon in the body is longer than those of the interferon such as interferon alfacon-1 (INFERGEN®), which has the amino acid sequence of SEQ ID NO: 1, but is not encoded by the nucleotide sequence of SEQ ID NO: 2 after injection under the same conditions.
  • interferon alfacon-1 IFERGEN®
  • the present recombinant interferon has the amino acid sequence of SEQ ID NO: 1, and is encoded by the nucleotide sequence of SEQ ID NO: 2, wherein the recombinant interferon has increased inhibitory activities on the expression of hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) of Hepatitis B Virus as compared to an interferon interferon such as interferon alfacon-1 (INFERGEN®), which has the amino acid sequence of SEQ ID NO: 1, but is not encoded by the nucleotide sequence of SEQ ID NO: 2.
  • HBsAg hepatitis B surface antigen
  • HBeAg hepatitis B e antigen
  • IFERGEN® interferon alfacon-1
  • the recombinant interferon (rSIFN-co) used in the present invention can be produced by the methods disclosed in, for example, U.S. Pat. No. 7,364,724, U.S. Pat. No. 7,585,647, U.S. Pat. No. 8,114,395, CN 1740197 A, CN 101001644 A, US 2009/0123417, US 2011/0158941 and WO 2011072487A1.
  • the present recombinant interferon can be produced by the method comprising the following steps: introducing a nucleotide sequence comprising SEQ ID NO: 2 that encodes the recombinant interferon into an isolated host cell; culturing the host cell under appropriate condition for expression of the recombinant interferon; and harvesting the recombinant interferon, wherein the recombinant interferon has an amino acid sequence of SEQ ID NO: 1, and the recombinant interferon inhibits secretion of hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) of Hepatitis B Virus.
  • HBsAg hepatitis B surface antigen
  • HBeAg hepatitis B e antigen
  • the host cell is Escherichia coli , such as Escherichia coli LGM 194.
  • the nucleotide sequence comprising SEQ ID NO: 2 is under the control of the promoter P BAD .
  • the harvesting step comprises extraction of the interferon from the fermentation broth, collection of the inclusion bodies, denaturation and renaturation of the harvested interferon. Still further, the harvesting step also comprises separation and purification of the recombinant interferon.
  • the specific activity of the present recombinant interferon is in a range of about 4.4 ⁇ 10 8 IU/mg to about 1.0 ⁇ 10 9 IU/mg, and optionally greater than 5.5 ⁇ 10 8 IU/mg.
  • Such specific activity is the ratio of the biological activity and the content of protein.
  • the biological activity is measured by a method well-known by the person skilled in the art such as the biological activity measurement method for the interferon (i.e. the cell lesion inhibition method) published in the Appendix X C in Chinese Pharmacopoeia (the third book), Edition 2010; and the content of the protein is measured by a method well-known by the person skilled in the art such as the second method (i.e. the Lowry method) of protein measurement method published in the Appendix VI B in Chinese Pharmacopoeia (the third book), Edition 2010.
  • the present recombinant interferon can be effectively used for treating tumors, in particular, solid tumors such as lung cancers and the like.
  • Monotherapy using the present recombinant interferon, rSIFN-co can suppress the growth of the tumors in patients, reduce the size of tumors in the patients effectively, even non-surgically directly eliminate tumors in the patients, reduce and even eliminate malignant pleural effusion, malignant ascites and/or malignant pericardial effusion, reduce tumor markers, effectively prolong the survival and/or tumor-free survival of the tumor patients and prevent postoperative cancer recurrence and/or metastasis of the tumor in the patients, and effectively treat advanced cancer patients and the cancer patients that are not indicated or appropriate for surgery.
  • the present recombinant interferon can effectively eliminate the tumors of the patients so as to achieve the effect of cure in some embodiments.
  • the present recombinant interferon has less side effects, so that it can be used in larger doses.
  • the diseases and conditions suitable for the treatment and/or prevention method of the invention include tumors.
  • tumors refers to all uncontrolled and malignant neoplastic cell growth and proliferation as well as all cancerous cells and tissues, and abnormally or aberrantly proliferative cells.
  • the tumors include malignant tumors.
  • cancer refers to physiological conditions of mammal generally characterized by unregulated cell growth and/or proliferation. In the context, the terms “cancer” and “malignant tumor” can be used interchangeably.
  • the tumors include solid tumors and non-solid tumors, optionally, the solid tumors.
  • solid tumor refers to the abnormal growth or caking of tissues, and generally does not include cyst or liquid areas.
  • non-solid tumor refers to neoplasia of the hemopoietic system, such as lymphoma, myeloma and leukemia, or neoplasia without solid formation generally and with spread substantially.
  • the solid tumors include but not limited to lung cancer, liver cancer, hepatocellular carcinoma (HCC), esophageal cancer, cholangiocarcinoma, gallbladder carcinoma, stomach cancer, abdominal cancer, gastrointestinal cancer, gastric cancer, pancreatic cancer, renal cell carcinoma, renal cancer, bone cancer, breast cancer, ovarian cancer, uterine cancer, cervical cancer, endometrial cancer, colorectal cancer, colon cancer, rectal cancer, bladder cancer, superficial bladder cancer, prostate cancer, adrenal tumors, squamous cell carcinoma, neuroma, malignant neuroma, myoepithelial carcinoma, synovial sarcoma, rhabdomyosarcoma, gastrointestinal interstitial cell tumor, skin cancer, basal cell carcinoma, malignant melanoma, thyroid cancer, nasopharyngeal carcinoma, hemangioma, epidermoid carcinoma, head and neck cancer, glioma, or Kaposi's sarcoma.
  • HCC hepatocellular
  • the non-solid tumors include but not limited to leukemia, acute leukemia, chronic leukemia, chronic myelocytic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, acute lymphoblastic leukemia, T-cell leukemia, hairy cell leukemia, polycythemia, myelodysplastic syndrome, multiple myeloma, lymphadenoma, Hodgkin's lymphoma, and Non-Hodgkin's lymphoma.
  • the tumors are lung tumors, and include but not limited to abnormally proliferative or aberrantly proliferative lung cells and/or malignant lung tumor.
  • lung tumor refers to any lung tumors, therefore, such tumors can be primary lung tumors and/or metastatic lung tumors, for example, the tumors are formed in a way that tumors at other positions are metastasized to the lung through various metastasis modes.
  • the lung tumors can be benign (non-carcinous), preinvasive lesion (precancerous lesion), or malignant (carcinous) lung tumors, such as lung cancers.
  • the lung tumors are the lung cancers, and include but not limited to small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).
  • SCLC small cell lung cancer
  • NSCLC non-small cell lung cancer
  • the term “lung cancer” refers to all types of lung cancers, and include but not limited to small cell lung cancer (SCLC) and the non-small cell lung cancer (NSCLC, including but not limited to adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous carcinoma and sarcomatoid carcinoma).
  • the SCLC includes but not limited to complex small cell lung cancer
  • the NSCLC includes but not limited to adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous carcinoma, sarcomatoid carcinoma, carcinoid and salivary gland cancer.
  • complex small cell lung cancer refers to one lung cancer, wherein the ingredients of the non-small cell lung cancer, such as large cell carcinoma, are mixed in the small cell lung cancer.
  • the lung tumors are preinvasive lesion (precancerous lesion), and include but not limited to squamous epithelial dysplasia of the lung, lung carcinoma in situ, atypical adenomatous hyperplasia of the lung, and diffuse and idiopathic neuroendocrine cell proliferation of the lung.
  • the metastatic lung tumors are the tumors formed in a way that breast cancer, colorectal cancer, stomach cancer, pancreatic cancer, renal cancer, malignant melanoma, prostate cancer, liver cancer, thyroid cancer and adrenal tumors and the like are metastasized to the lung.
  • the tumors are metastasized, and such metastasis can be in situ and in the distance.
  • metastasis refers to the spread of cancers or malignant tumors from the in-situ position to other in-vivo positions. Cancer cells can separate from in-situ tumors, penetrate into lymphatic vessels and blood vessels, and then grow in distant lesions in normal tissues at other in-vivo positions through blood circulation. The metastasis can be in situ or at the distance.
  • the lung tumors such as lung cancers can metastasize to lymph nodes, brain, central nervous system, bone, liver, adrenal, skin, intestine, thyroid, ovary, prostate and the like.
  • the present recombinant interferon can be used for treating these metastasized tumors such as metastasized lung cancers; particularly, the present recombinant interferon can relieve the symptoms caused by partial stress and invasion of the lung cancers to adjacent tissues, and treat the distant metastasis of the lung cancers.
  • the symptoms caused by the partial stress and invasion of the lung cancers include but not limited to dyscatabrosis caused by the metastasis and hyperplasia of lymph node around esophagus as well as dyspnea caused by the spread of tumors through the lung parenchyma lymphatic vessels.
  • the distant metastases of the lung cancers include but not limited to brain metastases of the lung cancers, central nervous system metastases of the lung cancers, bone metastases of the lung cancers, liver metastases of the lung cancers, adrenal metastases of the lung cancers, and other metastases such as skin metastases, thyroid metastases, ovary metastases, prostate metastases and the like of the lung cancers.
  • the tumors can be multiple primary cancers, for example, in the condition that the tumors are the lung cancers, such lung cancers can be multiple primary lung cancers such as the multiple primary lung cancers at different pulmonary segments or pulmonary lobes.
  • the term “multiple primary cancers” refers to more than two kinds of multiple primary malignant tumors that are formed at the same time or successively on a same body. Such multiple primary malignant tumors must be confirmed to be malignant and non-external metastasis tumors by histology.
  • multiple primary lung cancers refers to more than two multiple primary malignant tumors which are identical in histology and independent in existence, do not have metastasis between each other, and are generated at different pulmonary segments or pulmonary lobes.
  • the disease suitable for the treatment and/or prevention method of the invention also includes cancer emergencies, for example advanced cancer emergencies such as pleural effusion, ascites and/or pericardial effusion.
  • advanced cancer emergencies such as pleural effusion, ascites and/or pericardial effusion.
  • the pleural effusion, ascites and/or pericardial effusion are malignant pleural effusion, malignant ascites and/or malignant pericardial effusion.
  • the malignant pleural effusion can be caused by pleural primary tumors or pleural metastasized tumors, and is the common emergencies in the advanced lung cancers.
  • the pleural primary tumors include malignant and diffuse mesothelioma, and the pleural metastasized tumors are originated from lung cancer, breast cancer, lymphoma, ovarian cancer, endometrial cancer, cervical cancer, stomach cancer, colorectal cancer, pancreatic cancer, bladder cancer, liver cancer and the like.
  • the malignant pericardial effusion can be caused by lung cancer, breast cancer and the like.
  • the malignant pericardial effusion can be caused in a way that the lung cancer can be metastasized or can directly invade pericardium, which is also the common expression of the advanced lung cancers.
  • the malignant ascites can be caused by malignant tumors, wherein excessive liquid is accumulated in enterocoelia, and the malignant ascites is one of the advanced emergencies of cancers, and the malignant ascites are generally caused by ovarian cancer, cervical cancer, endometrial cancer, digestive tract tumor, lymphoma, breast cancer, peritoneal mesothelioma and the like.
  • the subject suitable for the treatment and/or prevention method of the invention includes mammal, which comprises but not limited to human and non-human mammal, optionally, the subject is human.
  • the terms “subject” and “patient” can be used interchangeably.
  • the subject with tumors is the subject previously diagnosed with tumors such as malignant tumors.
  • the subjects include but not limited to a subject with tumors such as malignant tumors that are not capable of being resected, a subject with tumors such as malignant tumors that are capable of being resected, a subject with cancers, a subject with metastasized tumors such as metastasized malignant tumors, and/or a subject with pleural effusion, ascites and/or pericardial effusion such as malignant pleural effusion, malignant ascites and/or malignant pericardial effusion.
  • the tumor is optionally resected by a surgical resection.
  • the solid tumors are capable of being resected or are not capable of being resected, such as solid tumors that are capable of being resected or are not capable of being resected surgically. In some embodiments, the solid tumors that are capable of being resected or are not capable of being resected, such as solid tumors that are capable of being resected or are not capable of being resected surgically, are advanced, or stage III or stage IV solid tumors. In some embodiments, the subjects are the subjects with or without indications for cancers or tumors surgery such as lung cancers surgery. In some embodiments, the solid tumors are solid tumors with or without indications for surgery such as indications for tumor surgery. In some embodiments, the solid tumors with or without indications for surgery such as indications for tumor surgery, are advanced, or stage III or stage IV solid tumors. In some embodiments, the solid tumors are lung cancers.
  • the term “indication for surgery” or “indicated for surgery” or “appropriate for surgery” refers to a surgical method which is employed when a disease is in accordance with the standard specified by treatment routine and cannot be cured by a non-surgical method and the surgical method can be employed for being helpful for the treatment of the disease.
  • the cancers without indications or not indicated for surgery include: (1) non-solid tumors or systematic tumors, such as leukemia, malignant lymphoma, bone tumor and the like; (2) cancers with extensive systematic metastases for which surgical treatment is of no value; (3) cancers at a position which is difficult for surgical resection, such as nasopharyngeal carcinoma, upper esophageal carcinoma, radix linguae carcinoma and the like; (4) cancers which easily metastasize at a very early stage, such as undifferentiated small cell lung cancer, so that surgical resection is generally not suggested; and (5) cancers with carcinoma cells which infiltrate into surrounding tissues while growing, have unclear boundary and cannot be completely resected by surgery, such as tonsil carcinoma, pancreas carcinoma and the like.
  • the solid tumors without indications or not indicated for surgery include: (1) systematic solid tumors such as bone tumor and the like; (2) solid tumors with extensive systematic metastases for which surgical treatment is of no value; (3) solid tumors at a position which is difficult for surgical resection, such as nasopharyngeal carcinoma, upper esophageal carcinoma, radix linguae carcinoma and the like; (4) solid tumors which easily metastasize at a very early stage, such as undifferentiated small cell lung cancer; and (5) solid tumors with carcinoma cells which infiltrate into surrounding tissues while growing, have unclear boundary and cannot be completely resected by surgery, such as tonsil carcinoma, pancreas carcinoma and the like.
  • tumors that are capable of being resected are tumors which are limited to primary organs and are suitable for surgical therapy, such as malignant tumors.
  • a subject with tumors such as malignant tumors that are not capable of being resected also includes a subject with tumors such as malignant tumors that are not capable of being resected surgically.
  • Such surgery can include surgical procedures, minimally invasive operation and the like.
  • the subject with tumors such as malignant tumors that are capable of being resected includes a subject with tumors such as malignant tumors which can be resected surgically.
  • the subjects include but not limited to early cancer patients, medium-term and advanced cancer patients, optionally medium-term or advanced cancer patients.
  • the term “early cancer” includes cancer in situ and stage I cancer
  • the term “medium-term cancer” includes stage II and stage III cancers
  • the term “advanced cancer” refers to metastatic cancers with extensive infiltration in situ or with metastises at remote organs, such as stage IV cancer.
  • the subjects include but not limited to stage 0, I, II, III or IV cancer patients, optionally stage III or stage IV cancer patients; and the subjects with metastasized tumors such as metastasized malignant tumors includes but not limited to subjects with tumors such as malignant tumors which are metastasized in situ or in the distance.
  • stage 0 I, II, III, or IV tumor or cancer
  • the stages of the tumor or cancer is defined by the TNM staging method well known in the art (see AJCC Cancer Staging Manual (Sixth Edition), Greene, F. L. et al. editor. LIAONING SCIENCE AND TECHNOLOGY PUBLISHING HOUSE, August 2005).
  • the subjects are medium-term, advanced, or Stage III or Stage IV cancer patients. In some embodiments, the subjects are advanced, or Stage III or Stage IV cancer patients.
  • the subjects with malignant pleural effusion, malignant ascites and/or malignant pericardial effusion include the subjects with malignant pleural effusion, malignant ascites and/or malignant pericardial effusion caused by cancers such as advanced, or Stage III or Stage IV cancers.
  • the cancers are lung cancers.
  • the subjects can be lung cancer patients, such as patients of lung cancer that is not capable of being resected surgically, the medium-term and advanced lung cancer patients, the Stage 0, I or II lung cancer patients, or Stage III or IV lung cancer patients, and the metastasized lung cancer patients or the lung cancer patients with malignant pleural effusion, malignant ascites and/or malignant pericardial effusion.
  • the lung cancer patients include but not limited to small cell lung cancer patients and non-small cell lung cancer patients.
  • other therapies or drugs can be administered to the subject before, simultaneously, and/or after administration of the present recombinant interferon.
  • the therapies are optionally anti-cancer therapies
  • the drugs are optionally anti-tumor drugs.
  • the term “administration” refers to giving a substance to achieve the therapeutic purposes.
  • the term “combination therapy” refers to employing two or more treatment means for the subjects in the process of the treatment period, such as employing the present recombinant interferon and extra treatment means. The extra treatment means can be employed for the subjects before, simultaneously, and/or after administration of the present recombinant interferon.
  • anti-cancer therapy refers to a useful therapy in the cancer treatment.
  • the other anti-cancer therapies include but not limited to chemotherapy, radiotherapy, surgical therapy, interventional therapy, biotherapy, gene therapy, ablation therapy, immune therapy, targeted therapy, traditional Chinese medicine therapy and any combination thereof.
  • the other anti-cancer therapies can be easily determined by the person skilled in the art.
  • the other anti-cancer therapies are optionally chemotherapy, radiotherapy, surgical therapy, targeted therapy and/or biotherapy.
  • the other anti-cancer therapies are optionally chemotherapy and/or radiotherapy.
  • chemotherapy refers to a drug therapy affecting cell growth and cell division, namely, the drug therapy is taken as a cell proliferation inhibitor or is used for inducing cell death (cell apoptosis). Compared with normal cells, cancer cells grow and divide uncontrollably so that the chemotherapy should be more effective to the cancer cells.
  • chemotherapy includes arterial infusion chemotherapy and embolism-form chemotherapy.
  • the chemotherapy can be the common first-line chemotherapy for the cancers.
  • chemotherapeutic drugs used in the first-line chemotherapy for treating lung cancer include but not limited to platinum compounds such as Cisplatin.
  • chemotherapeutic drugs used in the chemotherapy for the cancers in the invention include but not limited to alkylating agents such as nitrogen mustards including but not limited to chlormethine hydrochloride, chlorambucil, phenylalanine mustard, chlornaphazine, estramustine, cyclophosphamide, ifosfamide, Mechlorethamine, mustron, Melphalan, novembichin, phenesterin, Prednimustine, Trofosfamide and Uramustine; ethyleneimines and methyl melamines including but not limited triethylenemelamine, Thiotepa, MST-16, altretamine, triethylene melamine, triethylene phosphamide, triethylene Thiophosphoramide and trimethylol melamine; sulfoacid alkyl esters including but not limited to busulfan, improsulfan and piposulfan; and nitrosoureas including but not limited to carmustine, Semustine, Strept
  • chemotherapy protocols used for treating cancers such as lung cancers in the invention include but not limited to a CMC protocol (cyclohexyl nitrosourea, cyclophosphamide and Methotrexate), an EP protocol (etoposide and Cisplatin), an IVP protocol (ifosfamide, vindesine and Cisplatin), an ICE protocol (ifosfamide, Cisplatin and etoposide), a NIP protocol (Navelbine, ifosfamide and Cisplatin), a Paclitaxel+DDP/CBP protocol (Paclitaxel and Cisplatin/carboplatin), a docetaxel+DDP/CBP protocol (docetaxel and Cisplatin/carboplatin), a topotecan+DDP protocol (topotecan and Cisplatin), an IP protocol (Irinotecan and carboplatin), a MVP protocol (mitomycin, vindesine and Cisplatin),
  • chemotherapy protocols used for treating tumors such as cancers in the invention include but not limited to an FOLFOX protocol (see Newest Chemotherapy Development of Malignant Tumors , July, 2009, chief editor: Zheng Cuiping, Beijing: People's Military Medical Press, 1031), a DP protocol (see Newest Chemotherapy Development of Malignant Tumors , July, 2009, chief editor: Zheng Cuiping, Beijing: People's Military Medical Press, 232), a CHOPE protocol, a MTX protocol, a GCE protocol, an ESAP protocol, a CMOP protocol, a CHOP protocol (see Practical Anti - tumor Pharmacotherapeutics, 2002, chief editor: Liu Xinchun etc., Beijing: People's Medical Publishing House, 1031), a bleomycin+CHOP+Methotrexate protocol, a GP+Endostar protocol, a GP-T2 protocol, a TP protocol (see Practical Anti - tumor Pharmacotherapeutics, 2002, chief
  • the term “radiotherapy” refers to employing high-energy radiation for treating tumors such as cancers.
  • the radiotherapy includes external radiation such as external radiotherapy from a linear accelerator, and brachytherapy for which radioactive sources are placed near the surface of the human body or in the body cavity.
  • the radioactive sources include but not limited to ⁇ , ⁇ and ⁇ rays generated by radioactive nuclides, and electron beams, proton beams. Neutron beams, ⁇ meson beams and other heavy particle beams generated by various accelerators.
  • the radioactive nuclides include but not limited to 137 Cs, 60 Co, 131 I, 125 I, 32 P, 198 Au, 192 Ir, 90 Y, 186 Re and 109 Pd. Such radioactive sources can perform radiation in vitro and/or in vivo.
  • the typical radiotherapy is employed as one-time administration, and the usual dose is in the range of about 1 to about 200 grays/day, such as about 2 to about 150 grays/day, about 5 to about 100 grays/day, about 10 to about 70 grays/day, about 10 to about 50 grays/day and the like.
  • the radiotherapy used in the invention includes but not limited to two-dimensional conventional radiotherapy, three-dimensional conformal radiotherapy (3D-CRT), proton radiotherapy, brachytherapy, intensity modulated radiotherapy (IMRT), stereotactic radiotherapy (SRT), respiratory gating four-dimensional radiotherapy (4DRT) and gamma knife therapy, such as systematic gamma knife therapy and head gamma knife therapy.
  • 3D-CRT three-dimensional conformal radiotherapy
  • IMRT intensity modulated radiotherapy
  • SRT stereotactic radiotherapy
  • RDT respiratory gating four-dimensional radiotherapy
  • gamma knife therapy such as systematic gamma knife therapy and head gamma knife therapy.
  • the term “targeted therapy” refers to a therapy aiming at identifying specific target molecules which can be, for example, play a role in tumorigenesis or tumor proliferation or cell repairing. Such identification may be, for example, lead to the combination between the targeted therapy and the target molecules, and can enhance or reduce the activity of the target molecules.
  • Drugs used for the targeted therapy includes antibodies, in particular to monoclonal antibodies and small molecule drugs.
  • Potential targets include EGFR receptors, which playing a role in vasculogenesis, VEGFA ligands, which being important in vasculogenesis, or PARP1, which being important in cell repairing, because the tumors with cancer gene defect can be more sensitive to the chemical therapy due to the suppression to the PARP1.
  • the targeted drug includes but not limited to an anti-angiogenesis drug, Kinase inhibitor, pan Kinase inhibitor or growth factor inhibitor.
  • the anti-angiogenesis drug includes but not limited to EGF inhibitor, EGFR inhibitor, VEGF inhibitor, VEGFR inhibitor, TIE2 inhibitor, IGF1R inhibitor, COX-II (cyclo-oxygenase-II) inhibitor, MMP-2 (matrix metalloproteinase-2) inhibitor and MMP-9 (matrix metalloproteinase-9) inhibitor.
  • a targeted drug that can be used herein includes but not limited to at least one of: Gefitinib (Iressa), Erlotinib (TARCEVA®), Lapatinib (GSK572016), Vatalanib (PTK787), Imatinib (GLEEEVEC®), Dasatinib (Sprycel), Sunitinib (SUTENT®), Nilotinib (Tasigna), Semaxanib (SU5416), Pazopanib (GW-786034), Erbitux (IMC-C225), Panitumumab (Vectibix), Trastuzumab (Herceptin), Recombinant Human Endostatin (Endostar), Sorafenib (NEXAVAR®), Bevacizumab (Avastin), Alemtuzumab (Campath), Gemtuzumab (Mylotarg), ibritumomab tiuxetan (Zevalin), tositumom
  • the targeted drug in the targeted therapy used for treating cancers such as lung cancers in the invention includes but not limited to Gefitinib (Iressa), Erlotinib (TARCEVA®), and Recombinant Human Endostatin (Endostar).
  • the dose and duration of the drugs and/or the radioactive sources used in the chemical therapy, radiotherapy and/or targeted therapy can be easily determined by skilled physicians according to the experience and the practical situations of patients such as age, weight, general health state, gender, diet, administration time, drug interaction and illness severity.
  • surgical therapy refers to an invasive cancer therapy aiming at physically eliminating cancer cells.
  • the surgical therapy includes, for example, tumor resection and lymph node dissection.
  • gene therapy refers to a therapy by delivering recombinant genetic materials by virus or non-virus carriers ex vivo or in vivo so as to treat or prevent diseases or medical conditions, such as cancers.
  • ablation therapy refers to a well known tissue damage method, such as high-temperature ablation such as radio frequency, microwave and laser ablation, low-temperature ablation such as cryocare knife cryotherapy, chemical ablation, radioactive ablation and the like.
  • the term “immunotherapy” refers to a treatment strategy which is employed for regulating the immune system so as to prevent and/or treat specific diseases such as cancers.
  • vaccination is one immunotherapy.
  • the vaccine used in the present immunotherapy includes but limited to ALLOVECTIN® vaccine, LEUVECTIN® vaccine, VAXID® vaccine and the like.
  • the term “interventional therapy” refers to a treatment method with smallest trauma for performing local treatment to the lesion under the condition that the lesion is not operated through tiny channels made on the skin or original channels of the human body under the guidance of imaging equipment (such as a Digital Subtraction Angiography, a perspective machine, CT, MR and B ultrasonic).
  • the interventional therapy includes but not limited to transcatheter arterial chemoembolization, arterial infusion chemotherapy, high-temperature ablation such as radio frequency, microwave and laser ablation, low-temperature ablation such as cryocare knife cryotherapy, chemical ablation, radioactive ablation, gene drug arterial infusion, stent implantation and the like.
  • biotherapy refers to all treatment methods employing modern biotechnologies and the products (small molecule compounds, polypeptide, polysaccharide, protein, cells, tissues, genes, RNAs and the like) thereof.
  • the biotherapy can directly or indirectly mediate anti-tumor and tumor-killing effects.
  • the biotherapy used for treating the tumors includes but not limited to the application of non-specific immunologic stimulant, Biological Response Modifier (BRM), a tumor cell factor treatment and immunological effect cell treatments such as NK cell anti-tumor therapy, biology supporting therapy, tissue and cell transplanting therapy and the like.
  • BRM Bio Response Modifier
  • traditional Chinese medicine therapy refers to all methods employing the traditional Chinese medicine and drugs guided by Chinese medicine theories for treating diseases such as cancers.
  • interferon such as interferon ⁇ including interferon ⁇ -1a, interferon ⁇ -1b, interferon ⁇ -2a, interferon ⁇ -2b and the like, interferon ⁇ including interferon ⁇ -1a, interferon ⁇ -1b and the like, interferon ⁇ including interferon ⁇ -1b and the like, consensus interferon such as interferon ⁇ -con1, long-acting interferon such as PEGylation interferon, fusion protein of interferon and albumin, and fusion protein of interferon and IgG Fc fragment; colony stimulating factors (CSF) such as macrophage-colony stimulating factor (M-CSF), granulocyte-macrophage (GM-CSF) and granulocyte-colony stimulating
  • the present recombinant interferon can be incorporated into pharmaceutical compositions, so as to be administered to subjects.
  • the pharmaceutical composition comprises the present recombinant interferon and pharmaceutically acceptable carriers.
  • the “pharmaceutically acceptable carrier” herein includes any and all solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, and the like that are physiologically compatible.
  • Examples of pharmaceutically acceptable carriers include one or more of water, saline, phosphate buffered saline, dextrose, glycerol, ethanol and the like, as well as combinations thereof.
  • isotonic agents for example, sugars, polyalcohols such as mannitol, sorbitol, or sodium chloride in the composition.
  • Pharmaceutically acceptable carriers may further comprise minor amounts of auxiliary substances such as wetting or emulsifying agents, preservatives or buffers, which enhance the shelf life or effectiveness of the present recombinant interferon.
  • compositions of the invention may be in a variety of forms. These include, for example, liquid, semi-solid and solid dosage forms, such as liquid solutions (e.g., injectable and infusible solutions), dispersions or suspensions, aqueous solutions, tablets, capsules, oral solutions, patchs, sprays, suppositorys, powders and lyophilized powders.
  • liquid solutions e.g., injectable and infusible solutions
  • dispersions or suspensions e.g., aqueous solutions
  • aqueous solutions e.g., injectable and infusible solutions
  • aqueous solutions e.g., tablets, capsules, oral solutions, patchs, sprays, suppositorys, powders and lyophilized powders.
  • Typical pharmaceutical compositions are in the form of injectables or infusible solutions, lyophilized powders, sprays, and aqueous solutions.
  • the pharmaceutical composition can be prepared by any well known method in the pharmaceutical field with reference to: Gilman, etc., (editor) 1990 , The Pharmacological Bases of Therapeutics , the 8 th version, Pergamon Press; A. Gennaro (editor), Remington's Pharmaceutical Sciences , the 18 th version, 1990, Mack Publishing Co., Easton, Pa.; Avis, etc., (editor) 1993 , Pharmaceutical Dosage Forms: Parenteral Medications Dekke, New York; Lieberman, etc., (editor) 1990 , Pharmaceutical Dosage Forms: Tablets Dekker, New York; and Lieberman, etc., (editor) 1990 , Pharmaceutical Dosage Forms: Disperse Systems Dekker, New York.
  • systemic administration refers to a mode for administering compositions or drugs to a subject, in a manner that leads to systemic circulation of the drugs or compositions in the subject, such as the spreading or distribution of the administered compositions or drugs to all parts of the body.
  • systemic administration include, but are not limited to: intravenous injection, intra-arterial injection, intramuscular injection, subcutaneous injection, intra-lymphatic injection, oral administration, and the like.
  • local administration refers to administering a composition or drug into a limited or partial anatomy space.
  • Examples of local administration include but are not limited to: intratumoral, intra-lymph node, intra-pleural space, intraperitoneal cavity and the like.
  • topical administration refers to administering a drug or composition on the surface of skin or mucous membrane.
  • topical administration includes but is not limited to spraying the drug or composition onto the skin of a subject.
  • the present recombinant interferon can be administered to the subject by at least one administration route, the administration route comprises but not limited to: oral, rectal, sublingual, intravenous, intra-arterial, intramuscular, subcutaneous, intra-bone, intracutaneous, intra-articular, intraperitoneal, intrathecal, intracerebral, vaginal, percutaneous, transdermal, epidermal, transmucosal, transocular, pulmonary, nasal, abdominal, intrapleural, intraventricular, pericardial, inhalation, intratumoral, uterine, infiltration, and intravesical administration.
  • the administration route comprises but not limited to: oral, rectal, sublingual, intravenous, intra-arterial, intramuscular, subcutaneous, intra-bone, intracutaneous, intra-articular, intraperitoneal, intrathecal, intracerebral, vaginal, percutaneous, transdermal, epidermal, transmucosal, transocular, pulmonary, nasal, abdominal, intrapleural, intraventricular,
  • the present recombinant interferon can be administered to the subject by injection route, such as subcutaneous, intramuscular, intravenous, intra-arterial, intracerebral, intraperitoneal and/or intratumoral injection.
  • the present recombinant interferon can be administered to the subject by inhalation, such as pulmonary inhalation and nasal inhalation.
  • the inhalation can be dry powder inhalation and/or aerosol inhalation.
  • the present recombinant interferon can be administered to the subject by perfusion, such as intrapleural perfusion, abdominal perfusion, pericardial perfusion, uterine perfusion and/or intravesical perfusion.
  • the present recombinant interferon can be administered to lesion (such as the surfaces of skin and mucosa, superficial lymph nodes and/or subcutaneous tissue) by spray, such as percutaneous, epidermal, transdermal and/or transmucosal spray administration.
  • the infiltration administration includes pulmonary infiltration administration, percutaneous infiltration administration, epidermal infiltration administration, transmucosal infiltration administration, intrapleural infiltration administration, abdominal infiltration administration, uterine infiltration administration, vaginal infiltration administration, intravesical infiltration administration, pericardial infiltration administration and the like.
  • compositions suitable for injection/perfusion include sterile aqueous solutions (where water soluble) or dispersions and sterile powders for the extemporaneous preparation of sterile injectable solutions or dispersion.
  • the composition must be sterile and should be fluid so as to be administered using a syringe.
  • Such compositions should be stable during manufacture and storage and must be preserved against contamination from microorganisms such as bacteria and fungi.
  • the carrier can be a solvent or dispersion medium containing, for example, water, ethanol, polyol (such as glycerol, propylene glycol, and liquid polyethylene glycol), and suitable mixtures.
  • compositions that can delay absorption include agents such as aluminum monostearate and gelatin.
  • Sterile injection/perfusion solutions can be prepared by incorporating the present recombinant interferon in the required amount in an appropriate solvent with one or a combination of ingredients as required, followed by sterilization.
  • dispersions are prepared by incorporating the present recombinant interferon into a sterile vehicle that contains a basic dispersion medium, and the other required ingredients.
  • Sterile powders for the preparation of sterile injection/perfusion solutions, methods of preparation include vacuum drying and freeze-drying that yield a powder containing the active ingredient and any desired ingredient from a sterile solutions.
  • the present recombinant interferon can be delivered by any of a variety of inhalation devices know in the art for administration of a therapeutic agent by inhalation. These devices include metered dose inhalers, nebulizers, dry powder generators, sprayers, and the like. Other devices suitable for inhalation administration of the present recombinant interferon are also known in the art.
  • Metered dose inhalers like the Ventolin® metered dose inhaler, typically use a propellent gas and require actuation during inspiration (See, e.g., WO 94/16970, WO 98/35888).
  • Dry powder inhalers like TurbuhalerTM (Astra), Rotahaler® (Glaxo), Diskus® (Glaxo), SpirosTM inhaler (Dura), devices marketed by Inhale Therapeutics, and the Spinhaler® powder inhaler (Fisons), use breath-actuation of a mixed powder (U.S. Pat. No. 4,668,218 Astra, EP 237507 Astra, WO 97/25086 Glaxo, WO 94/08552 Dura, U.S. Pat. No.
  • Nebulizers like AERxTM Aradigm, the Ultravent® nebulizer (Mallinckrodt), the Acorn II® nebulizer (Marquest Medical Products) (U.S. Pat. No. 5,404,871 Aradigm, WO 97/22376), and the AP-100200 type spray inhaler (Taiwan Albert incorporated company). Producing aerosols from solutions, while metered dose inhalers, dry powder inhalers, etc. generate small particle aerosols.
  • the present recombinant interferon is delivered by a nebulizer.
  • the inhalation devices for administering the present recombinant interferon have several desirable features.
  • delivery by the inhalation device is advantageously reliable, reproducible, and accurate.
  • the inhalation device can optionally deliver small dry particles or aerosol, e.g., less than about 10 ⁇ m, for example about 0.5 ⁇ m to about 5 ⁇ m, for good respirability.
  • a spray including the present recombinant interferon can be produced by forcing a suspension or solution of the recombinant interferon through a nozzle under pressure.
  • the nozzle size and configuration, the applied pressure, and the liquid feed rate can be chosen to achieve the desired output and particle size.
  • An electrospray can be produced, for example, by an electric field in connection with a capillary or nozzle feed.
  • particles delivered by a sprayer have a particle size less than about 10 ⁇ m, optionally, in the range of about 0.5 ⁇ m to about 5 ⁇ m.
  • Formulations of the present recombinant interferon suitable for use with a sprayer typically include ones at a concentration in a range of about 0.01 mg to about 5 mg, such as about 0.03 mg to about 2 mg, about 0.05 mg to about 1 mg, and about 0.1 mg to about 0.5 mg of the recombinant interferon per ml of solution.
  • the formulation can include an excipient or agent for stabilization of the present recombinant interferon, such as a buffer, a reducing agent, a bulk protein, or a carbohydrate.
  • Bulk proteins useful in formulating the recombinant interferon include albumin, protamine, or the like.
  • Typical carbohydrates useful in formulating the recombinant interferon include sucrose, mannitol, lactose, trehalose, glucose, or the like.
  • the present recombinant interferon formulation can also include a surfactant, which can reduce or prevent surface-induced aggregation of the recombinant interferon caused by atomization of the solution in forming an aerosol.
  • Effective amount of the present recombinant interferon can be administered to the subjects such as cancer subjects, and such effective amount can be a therapeutically effective amount or a prophylactically effective amount according to the method of the invention.
  • the term “effective amount” refers to an amount effective, at dosages and for periods of time necessary, to achieve the desired therapeutic or prophylactic result.
  • a therapeutically effective amount of the present recombinant interferon may vary according to factors such as the disease state, age, sex, and weight of the individual, and the ability of the recombinant interferon to elicit a desired response in the individual.
  • a therapeutically effective amount is also one in which any toxic or detrimental effects of the recombinant interferon are outweighed by the therapeutically beneficial effects.
  • prophylactically effective amount refers to an amount effective, at dosages and for periods of time necessary, to achieve the desired prophylactic result. Typically but no surely, since a prophylactic dose is used in subjects prior to or at an earlier stage of disease, the prophylactically effective amount will be less than the therapeutically effective amount.
  • the present recombinant interferon can be administered to the subjects such as the cancer subjects in different amounts of single doses.
  • the single doses of the present recombinant interferon can be in the range of about 2 ⁇ g to about 2000 ⁇ g, optionally about 4 ⁇ g to about 1500 ⁇ g, and further optionally about 9 ⁇ g to about 1000 ⁇ g.
  • the term “single dose” refers to an amount of drug which can be at administered one time, that can be therapeutically or prophylactically effective by itself or cumulatively with other single doses.
  • Such administration includes systemic administration, local administration and/or topical administration.
  • the single dose of the recombinant interferon can be in the range of about 4 ⁇ g to about 70 ⁇ g, optionally, about 4 ⁇ g to about 50 ⁇ g, and further optionally, about 4 ⁇ g to about 30 ⁇ g, wherein the single dose can be about 4 ⁇ g, about 4.5 ⁇ g, about 5 ⁇ g, about 6 ⁇ g, about 7 ⁇ g, about 8 ⁇ g, about 9 ⁇ g, about 10 ⁇ g, about 11 ⁇ g, about 12 ⁇ g, about 13 ⁇ g, about 13.5 ⁇ g, about 14 ⁇ g, about 15 ⁇ g, about 16 ⁇ g, about 17 ⁇ g, about 18 ⁇ g, about 19 ⁇ g, about 20 ⁇ g, about 21 ⁇ g, about 22 ⁇ g,
  • the single dose of the recombinant interferon can be in a range of about 60 ⁇ g to about 600 ⁇ g, optionally, about 60 ⁇ g to about 500 ⁇ g, further optionally, about 80 ⁇ g to about 400 ⁇ g, and still further optionally, about 100 ⁇ g to about 250 ⁇ g, wherein the single dose can be about 60 ⁇ g, about 70 ⁇ g, about 80 ⁇ g, about 90 ⁇ g, about 100 ⁇ g, about 110 ⁇ g, about 120 ⁇ g, about 130 ⁇ g, about 140 ⁇ g, about 150 ⁇ g, about 160 ⁇ g, about 170 ⁇ g, about 180 ⁇ g, about 190 ⁇ g, about 200 ⁇ g, about 210 ⁇ g, about 220 ⁇ g, about 230 ⁇ g, about 240 ⁇ g, about 250 ⁇ g, about 260 ⁇ g, about 270 ⁇ g, about
  • the single dose of the recombinant interferon can be in a range of about 100 ⁇ g to about 2000 ⁇ g, optionally, about 100 ⁇ g to about 1500 ⁇ g, further optionally, about 150 ⁇ g to about 800 ⁇ g, and still further optionally, about 200 ⁇ g to about 600 ⁇ g, wherein the single dose can be about 100 ⁇ g, about 110 ⁇ g, about 120 ⁇ g, about 130 ⁇ g, about 140 ⁇ g, about 150 ⁇ g, about 160 ⁇ g, about 170 ⁇ g, about 180 ⁇ g, about 190 ⁇ g, about 200 ⁇ g, about 210 ⁇ g, about 220 ⁇ g, about 230 ⁇ g, about 240 ⁇ g, about 250 ⁇ g, about 260 ⁇ g, about 270 ⁇ g, about 280 ⁇ g
  • the single dose of the recombinant interferon can be in a range of about 30 ⁇ g to about 2000 ⁇ g, optionally, about 100 ⁇ g to about 1500 ⁇ g, further optionally, about 150 ⁇ g to about 1000 ⁇ g, still optionally, about 200 ⁇ g to about 800 ⁇ g, and still further optionally, about 200 ⁇ g to about 400 ⁇ g, wherein the single dose can be about 30 ⁇ g, about 40 ⁇ g, about 50 ⁇ g, about 60 ⁇ g, about 70 ⁇ g, about 80 ⁇ g, about 90 ⁇ g, about 100 ⁇ g, about 110 ⁇ g, about 120 ⁇ g, about 130 ⁇ g, about 140 ⁇ g, about 150 ⁇ g, about 160 ⁇ g, about 170 ⁇ g, about 180 ⁇ g, about
  • the single dose of the recombinant interferon can be in a range of about 6 ⁇ g to about 100 ⁇ g, optionally, about 10 ⁇ g to about 40 ⁇ g, and further optionally, about 20 ⁇ g to about 40 ⁇ g, wherein the single dose can be about 6 ⁇ g, about 7 ⁇ g, about 8 ⁇ g, about 9 ⁇ g, about 10 ⁇ g, about 11 ⁇ g, about 12 ⁇ g, about 13 ⁇ g, about 14 ⁇ g, about 15 ⁇ g, about 16 ⁇ g, about 17 ⁇ g, about 18 ⁇ g, about 19 ⁇ g, about 20 ⁇ g, about 21 ⁇ g, about 22 ⁇ g, about 23 ⁇ g, about 24 ⁇ g, about
  • the present recombinant interferon can be administered to the subjects through different administration protocols.
  • the present recombinant interferon can be administered to the subject about 1, 2, 3, 4, 5, 6, 7, 8, or more times per day, or the present recombinant interferon can be administered to the subject once at the time interval of every about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or 21 days, every month, every 2 months, or longer time.
  • the present recombinant interferon can be administered to the subject once at the time interval of every about 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, every 2 weeks, every 3 weeks, every month, every 2 months, every 3 months, every half year, every 1 year, or a longer time.
  • treatment cycle refers to a biological or medical response time length reached by the present recombinant interferon or the pharmaceutical composition comprising the recombinant interferon, and explored for researchers, veterinarians, medical practitioners or other clinicians observed in tissues, systems, animals, individuals or human beings.
  • the duration of such one treatment cycle is at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or about 6 years and the like, or the duration can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about 9 months and the like.
  • the present recombinant interferon can be administered for a long time, namely, namely, the lasting prolonged time in one treatment cycle includes over the life time of the subject so as to improve or control or limit the symptom of the subjects.
  • the present recombinant interferon can be administered to the subjects one or more times.
  • the present recombinant interferon can be administered to the subjects in more treatment cycles.
  • treatment cycles can be 2, 3, 4, 5, 6, 7, 8, 9, 10, or more treatment cycles; and the duration of the treatment cycles can include over the life time of the subject.
  • the time intervals i.e.
  • the time interval can be at least about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, about 6 years and the like; and such time interval can also be about 2 days to about 6 years, about 4 days to about 3 years, about 1 week to about 1 year, about 2 months to about 9 months, or about 3 months to about 6 months and the like.
  • the dose in every administration can be the same or different, for example, the present recombinant interferon is administered for one or more times in a lower dose, and then the present recombinant interferon is administered for one or more times in an increased or gradually-increased dose; or, the present recombinant interferon is administered for one or more times in a smaller dose, then the present recombinant interferon is administered for one or more times in an increased or gradually-increased dose, and the present recombinant interferon is administered for one or more times in a decreased or gradually-decreased dose; or, the present recombinant interferon is administered for one or more times in a larger dose, and then the present recombinant interferon is administered for one or more times in a decreased or gradually-decreased dose; or, the present recombinant interferon is administered for one or more times in a larger dose, then the present recombinant interferon is administered for one or more times in a
  • the later increasingly administered dose can be about 110% to about 500%, including, for example about 110%, about 120%, about 130%, about 140%, about 150%, about 160%, about 170%, about 180%, about 190%, about 200%, about 220%, about 240%, about 260%, about 280%, about 300%, about 350%, about 400%, about 450% and about 500%, of the previously administered dose.
  • the later gradually-increased administered dose can be about 110% to about 500% including, for example about 110%, about 120%, about 130%, about 140%, about 150%, about 160%, about 170%, about 180%, about 190%, about 200%, about 220%, about 240%, about 260%, about 280%, about 300%, about 350%, about 400%, about 450% and about 500%, of the previously administered dose sequentially.
  • the gradually-increased dose can be increased by 1 time, 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times, 10 times, or more times, and then the last dose can be kept till the end of the treatment cycle.
  • the later decreasingly administered dose can be about 5% to about 99% including, for example, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95% and about 99%, of the previously administered dose.
  • the later gradually-decreased administered dose can be about 5% to about 99% including, for example, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95% and 99%, of the previously administered dose sequentially.
  • the gradually-decreased dose can be decreased by 1 time, 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times, 10 times, or more times, and then the last dose can be kept till the end of the treatment cycle.
  • the single doses of the present recombinant interferon in two different treatment cycles can be the same or different.
  • the single dose can be gradually increased or decreased. Compared with the previously administered dose, the increasing or decreasing degree is as mentioned above.
  • the gradually increasing or the gradually decreasing can be linear increasing or decreasing, for example, the first administered drug is 9 ⁇ g, then the later increased dose is 18 ⁇ g, 36 ⁇ g, 72 ⁇ g and the like sequentially, namely, the sequential increasing rate is 100%; or, the gradually increasing or the gradually decreasing can be non-linear increasing or decreasing, for example, the first administered drug is 9 ⁇ g, then the later increased dose can be 15 ⁇ g, 18 ⁇ g, 21 ⁇ g and the like, namely, compared with the previous administered drug, the drug increasing degree at every time can be different.
  • administration dosage and the administration protocol can be changed reasonably by the person skilled in the art based on the teaching of the invention, with the type and severity of the disorder to be released, the subject, the administration methods and the like.
  • the present invention provides a method for treating a tumor in a subject, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the present invention provides a method for treating tumor in a subject, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2, and at least one other anti-cancer therapy, wherein the at least one other anti-cancer therapy is administered to the subject before, simultaneously, and/or after administration of the recombinant interferon, and wherein the tumor is a cancer or solid tumor that is not indicated nor appropriate for surgery, or the tumor is a solid tumor that cannot be resected, and the combination of the recombinant interferon and the at least one other anti-cancer therapy eliminate the tumor or reduce the size of the tumor compared to the tumor before treatment.
  • the present invention provides a method for preventing tumor recurrence and/or metastasis or prolonging or maintaining a tumor-free status in a subject with a tumor after at least one anti-cancer therapy, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the present invention provides a non-surgical method for eliminating a tumor in a subject or reducing the size of a tumor in a subject, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the present invention provides a method for eliminating or reducing the pleural effusion, ascites, and/or pericardial effusion in a subject with tumor, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the present invention provides a method for treating tumor in a subject, comprising topically or locally administering to the tumor lesions of the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the present invention provides a method for eliminating or reducing metastatic tumor lesions in a subject, comprising topically or locally administering to the metastatic tumor lesions of the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the present invention provides a method for eliminating or reducing the bone metastatic lesions of tumor in a subject, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 by topical or local administration, wherein the topical or local administration comprises transdermal administration and/or infiltration administration, optionally, the recombinant interferon is administered to the bone metastatic lesions of tumor of the subject.
  • the present invention provides a method for eliminating or reducing the bone lesions of tumor such as bone metastatic lesions of tumor, muscular lesions of tumor such as muscular metastatic lesions of tumor, subcutaneous tissue lesions of tumor such as subcutaneous tissue metastatic lesions of tumor, prostatic lesions of tumor such as prostatic metastatic lesions of tumor, and/or lymph node lesions of tumor such as lymph node metastatic lesions of tumor in a subject, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 by any administration route through the skin, so that eliminating or reducing the bone lesions of tumor such as bone metastatic lesions of tumor, muscular lesions of tumor such as muscular metastatic lesions of tumor, subcutaneous tissue lesions of tumor such as subcutaneous tissue metastatic lesions of tumor, prostatic lesions of tumor such as prostatic metastatic lesions of tumor, and/or lymph node lesions of tumor such as lymph node metastatic lesions of tumor, optionally, the recombinant interferon is administered to the meta
  • the present invention provides a method for treating lung cancer in a subject, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the present invention provides a method for treating lung cancer in a subject, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 and one or more chemotherapeutic drugs in two or more treatment cycles, and then administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 and one or more targeted drugs in one or more treatment cycles.
  • the present invention provides a method for treating lung cancer in a subject, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 by subcutaneous administration and/or intramuscular administration, wherein the recombinant interferon is administered in an amount in a range of about 2 ⁇ g to about 70 ⁇ g, optionally about 4 ⁇ g to about 50 ⁇ g, further optionally about 4 ⁇ g to about 30 ⁇ g by one subcutaneous administration and/or intramuscular administration, the recombinant interferon is administered by subcutaneous administration and/or intramuscular administration once every about 1 to about 7 days, optionally every about 1 to about 2 days, lasting at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months
  • the present invention provides a method for treating lung cancer in a subject, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 by subcutaneous administration and/or intramuscular administration, wherein the recombinant interferon is administered one or more times by subcutaneous administration and/or intramuscular administration at an induction dose in a range of about 2 ⁇ g to about 10 ⁇ g each time, optionally about 4 ⁇ g to about 10 ⁇ g each time, further optionally about 4.5 ⁇ g to about 9 ⁇ g each time, such as about 4.5 ⁇ g each time or about 9 ⁇ g each time, and then the recombinant interferon is administered more times by subcutaneous administration and/or intramuscular administration at a therapeutic dose in a range of about 10 ⁇ g to about 70 ⁇ g each time, optionally about 12 ⁇ g to about 50 ⁇ g each time, further optionally about 12 ⁇ g to about 30 ⁇ g each time.
  • the present invention provides a method for treating cancer in a subject, wherein the cancer originates from lung cancer in the subject and metastasizes to brain, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2, wherein the recombinant interferon is administered one or more times by subcutaneous administration and/or intramuscular administration at an induction dose in a range of about 2 ⁇ g to about 10 ⁇ g each time, optionally about 4 ⁇ g to about 10 ⁇ g each time, further optionally about 4.5 ⁇ g to about 9 ⁇ g each time, such as about 4.5 ⁇ g each time or about 9 ⁇ g each time, and then the recombinant interferon is administered more times by subcutaneous administration and/or intramuscular administration at a therapeutic dose in a range of about 10 ⁇ g to about 70 ⁇ g each time, optionally about 12 ⁇ g to about 50 ⁇ g each time, further optionally about 12 ⁇ g to about 30 ⁇ g each time, and the
  • the present invention provides a method for treating cancer in a subject, wherein the cancer originates from lung cancer in the subject and metastasizes to bone or liver, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2, wherein the recombinant interferon is administered one or more times by subcutaneous administration and/or intramuscular administration at an induction dose in a range of about 2 ⁇ g to about 10 ⁇ g each time, optionally about 4 ⁇ g to about 10 ⁇ g each time, further optionally about 4.5 ⁇ g to about 9 ⁇ g each time, such as about 4.5 ⁇ g each time or about 9 ⁇ g each time, and then the recombinant interferon is administered more times by subcutaneous administration and/or intramuscular administration at a therapeutic dose of about 10 ⁇ g-about 70 ⁇ g each time, optionally about 12 ⁇ g to about 50 ⁇ g each time, further optionally about 12 ⁇ g to about 30 ⁇ g each time.
  • the present invention provides a method for treating cancer in a subject, wherein the cancer originates from lung cancer in the subject and metastasizes to lymph nodes, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2, wherein the recombinant interferon is administered one or more times by subcutaneous administration and/or intramuscular administration at an induction dose in a range of about 2 ⁇ g to about 10 ⁇ g each time, optionally about 4 ⁇ g to about 10 ⁇ g each time, further optionally about 4.5 ⁇ g to about 9 ⁇ g each time, such as about 4.5 ⁇ g each time or about 9 ⁇ g each time, and then the recombinant interferon is administered more times by subcutaneous administration and/or intramuscular administration at a therapeutic dose of about 10 ⁇ g to about 70 ⁇ g each time, optionally about 12 ⁇ g to about 50 ⁇ g each time, further optionally about 12 ⁇ g to about 30 ⁇ g each time, and the recombinant
  • the present invention provides a method for treating lung cancer in a subject, wherein the subject has pleural effusion, ascites and/or pericardial effusion, comprising administering to the subject a recombinant interferon encoded by SEQ ID NO: 2 by topical or local administration.
  • the present invention provides uses of a recombinant interferon encoded by SEQ ID NO: 2 in preparation of drugs for treating tumors in a subject.
  • the present invention provides uses of a recombinant interferon encoded by SEQ ID NO: 2 and other anti-tumor drugs in preparation of drugs for treating tumors in a subject.
  • the present invention provides uses of a recombinant interferon encoded by SEQ ID NO: 2 in preparation of drugs for preventing tumor recurrence and/or metastasis after anti-tumor therapies in a subject.
  • the present invention provides uses of a recombinant interferon encoded by SEQ ID NO: 2 in preparation of drugs for eliminating a tumor or reducing the size of a tumor in a subject by non-surgical method.
  • the present invention provides uses of a recombinant interferon encoded by SEQ ID NO: 2 in preparation of drugs for eliminating or reducing pleural effusion, ascites, and/or pericardial effusion in a subject with tumor.
  • the present invention provides a uses of a recombinant interferon encoded by SEQ ID NO: 2 in preparation of drugs for treating lung cancer in a subject.
  • the present invention provides uses of a recombinant interferon encoded by SEQ ID NO: 2 in preparation of drugs for treating lung cancer in a subject in combination with chemotherapeutic drugs, targeted drugs.
  • the subject is an early, medium-term, or advanced cancer patient, optionally, the subject is a medium-term, or advanced cancer patient, further optionally, the subject is an advanced cancer patient, such as an advanced lung cancer patient.
  • the subject can be a stage 0, I, II, III, or IV cancer patient, optionally, the subject is an stage III or stage IV cancer patient, such as an stage III or stage IV lung cancer patient.
  • stage III or stage IV cancer patient such as an stage III or stage IV lung cancer patient.
  • Such cancer patient can be a patient with metastasized tumors, such as the tumors which are metastasized in situ or in the distance.
  • the subject is a medium-term, advanced cancer patient, or stage III or stage IV cancer patient, optionally, the subject is an advanced, or stage III or stage IV cancer patient.
  • the tumor is a cancer or a solid tumor with or without indications for surgery.
  • the tumor in a subject is a tumor that is capable of being resected. In some embodiments, the tumor in a subject is a tumor that is not capable of being resected. In some embodiments, the surgeries include but not limited to surgical procedures.
  • the subject is a subject with solid tumors.
  • the solid tumor is a solid tumor that is capable of or is not capable of being resected.
  • the solid tumor that is capable of or is not capable of being resected is an advanced solid tumor.
  • the solid tumor is a solid tumor with or without indications for surgery, such as indications for tumor surgery.
  • the solid tumor with or without indications for surgery such as indications for tumor surgery is an advanced, or stage III or stage IV solid tumor.
  • the tumor is a solid tumor.
  • the solid tumor comprises one or more of: lung cancer, liver cancer, hepatocellular carcinoma (HCC), esophageal cancer, cholangiocarcinoma, gallbladder carcinoma, stomach cancer, abdominal cancer, gastrointestinal cancer, gastric cancer, pancreatic cancer, renal cell carcinoma, renal cancer, bone cancer, breast cancer, ovarian cancer, uterine cancer, cervical cancer, endometrial cancer, colorectal cancer, colon cancer, rectal cancer, bladder cancer, superficial bladder cancer, prostate cancer, adrenal tumors, squamous cell carcinoma, neuroma, malignant neuroma, myoepithelial carcinoma, synovial sarcoma, rhabdomyosarcoma, gastrointestinal interstitial cell tumor, skin cancer, basal cell carcinoma, malignant melanoma, thyroid cancer, nasopharyngeal carcinoma, hemangioma, epidermoid carcinoma, head and neck cancer, glioma, or Kaposi's sar
  • the tumor is a non-solid tumor.
  • the non-solid tumor comprises one or more of leukemia, acute leukemia, chronic leukemia, chronic myelocytic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, acute lymphoblastic leukemia, T-cell leukemia, hairy cell leukemia, polycythemia, myelodysplastic syndrome, multiple myeloma, lymphadenoma, Hodgkin's lymphoma, or Non-Hodgkin's lymphoma.
  • the effective amount is a therapeutically effective amount or a prophylactically effective amount.
  • the present recombinant interferon can be administered to the subject in single dose of about 2 ⁇ g to about 2000 ⁇ g, optionally, about 4 ⁇ g to about 1500 ⁇ g, further optionally, about 9 ⁇ g to about 1000 ⁇ g, and still further optionally, about 9 ⁇ g to about 600 ⁇ g.
  • the therapeutically effective amount is about 2 ⁇ g to about 70 ⁇ g, optionally about 4 ⁇ g to about 50 ⁇ g, further optionally about 4 ⁇ g to about 30 ⁇ g, and still further optionally, about 9 ⁇ g to about 30 ⁇ g.
  • the prophylactically effective amount is about 2 ⁇ g to about 70 ⁇ g, optionally about 4 ⁇ g to about 50 ⁇ g, further optionally about 4 ⁇ g to about 30 ⁇ g, and still further optionally, about 9 ⁇ g to about 30 ⁇ g.
  • the present recombinant interferon and/or chemotherapeutic drugs, targeted drugs, biological drugs and the like combined with the present recombinant interferon can be administered to the subject by at least one of: systemic administration, topical administration, and local administration.
  • the present recombinant interferon and/or chemotherapeutic drugs, targeted drugs, biological drugs and the like combined with the present recombinant interferon can be administered to the subject by an administration route, the administration route comprises one or more of oral, rectal, sublingual, intravenous, intra-arterial, intramuscular, subcutaneous, intra-bone, intracutaneous, intra-articular, intraperitoneal, intrathecal, intracerebral, vaginal, percutaneous, transdermal, epidermal, transmucosal, transocular, pulmonary, nasal, abdominal, intrapleural, intraventricular, pericardial, inhalation, intratumoral, uterine, infiltration, or intravesical administration.
  • the administration route comprises one or more of oral, rectal, sublingual, intravenous, intra-arterial, intramuscular, subcutaneous, intra-bone, intracutaneous, intra-articular, intraperitoneal, intrathecal, intracerebral, vaginal, percutaneous, transdermal, epidermal,
  • the present recombinant interferon and/or chemotherapeutic drugs, targeted drugs, biological drugs and the like combined with the present recombinant interferon can be administered to the subject by subcutaneous, intramuscular, inhalation, infiltration, intrapleural, abdominal, pericardial, intratumoral, spary administration or any combination thereof.
  • the present recombinant interferon and/or chemotherapeutic drugs, targeted drugs, biological drugs and the like combined with the present recombinant interferon can be administered to the subject by intramuscular and/or subcutaneous administration.
  • the present recombinant interferon and/or chemotherapeutic drugs, targeted drugs, biological drugs and the like combined with the present recombinant are administered to the operative site, which can be administered to the subject by topical or local administration, such as infiltration, intrapleural, abdominal, pericardial, uterine, intravesical, intratumoral, pulmonary, nasal, percutaneous, transdermal, epidermal, and/or transmucosal administration.
  • the present recombinant interferon and/or chemotherapeutic drugs, targeted drugs, biological drugs and the like combined with the present recombinant interferon can be administered to the subject by injection, such as subcutaneous, intramuscular, intravenous, intra-arterial, intracerebral, intraperitoneal, intratumoral, intra-articular, intrathecal and intra-bone injection and the like.
  • the inhalation when administering by inhalation, can be pulmonary and/or nasal inhalation.
  • the inhalation administration can be dry powder inhalation or aerosol inhalation.
  • the present recombinant interferon and/or chemotherapeutic drugs, targeted drugs, biological drugs and the like combined with the present recombinant interferon can be further administered to the subject by perfusion, such as intrapleural, abdominal, uterine, intravesical, and/or pericardial perfusion.
  • the present recombinant interferon and/or chemotherapeutic drugs, targeted drugs, biological drugs and the like combined with the present recombinant interferon can be further administered to the subject by spray, such as percutaneous, epidermal, transdermal and/or transmucosal spray.
  • the single dose can be about 2 ⁇ g to about 70 ⁇ g, optionally about 4 ⁇ g to about 50 ⁇ g, and further optionally about 4 ⁇ g to about 30 ⁇ g, including but not limited to about 2 ⁇ g, about 3 ⁇ g, about 4 ⁇ g, about 4.5 ⁇ g, about 9 ⁇ g, about 13.5 ⁇ g, about 15 ⁇ g, about 18 ⁇ g, about 21 ⁇ g, about 25.5 ⁇ g, about 30 ⁇ g, about 40 ⁇ g, about 50 ⁇ g, about 60 ⁇ g, and about 70 ⁇ g.
  • the present recombinant interferon is administered by subcutaneous and/or intramuscular administration once every about 1 day to about 7 days, optionally once every about 1 day to about 2 days.
  • the injection lasts at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject; or the duration can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about
  • the single dose of the recombinant interferon can be in the range of about 60 ⁇ g to about 600 ⁇ g, optionally about 60 ⁇ g to about 500 ⁇ g, further optionally about 80 ⁇ g to about 400 ⁇ g, and still further optionally about 100 ⁇ g to about 250 ⁇ g.
  • the present recombinant interferon is administered via intratumoral administration once every about 1 day to about 10 days, optionally once every about 1 day to about 7 days such as every about 1, 2, 3, 4, 5, 6 or 7 days.
  • the intratumoral administration such as intratumoral injection lasts at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject; or the duration can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about 9 months and the like.
  • the protocol of intratumoral administration is as follow: the recombinant interferon is administered by intratumoral injection once every about 1 day for about 4 to about 8 times, and then the recombinant interferon is administered by intratumoral injection once every about 3 days to about 5 days for about 4 to about 8 times, and then the recombinant interferon is administered by intratumoral injection once every about 7 days, the intratumoral administration is stopped when the tumor disappears or becomes too small to conduct the intratumoral injection, wherein the recombinant interferon is administered in an amount of about 60 ⁇ g to about 600 ⁇ g, optionally about 60 ⁇ g to about 500 ⁇ g, further optionally about 80 ⁇ g to about 400 ⁇ g, still further optionally about 100 ⁇ g to about 250 ⁇ g by once intratumoral injection.
  • the single dose of the recombinant interferon can be about 100 ⁇ g to about 2000 ⁇ g, optionally about 100 ⁇ g to about 1500 ⁇ g, further optionally about 150 ⁇ g to about 800 ⁇ g, and still further optionally about 200 ⁇ g to about 600 ⁇ g, including but not limited to about 100 ⁇ g, about 200 ⁇ g, about 300 ⁇ g, about 400 ⁇ g, about 500 ⁇ g, about 600 ⁇ g, about 700 ⁇ g, about 800 ⁇ g, about 900 ⁇ g and about 1000 ⁇ g.
  • the present recombinant interferon is administered via inhalation once every about 1 day to about 3 days, optionally every about 1 day.
  • the inhalation lasts at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject; or the duration can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about 9 months and the like.
  • the single dose of the recombinant interferon can be about 30 ⁇ g to about 2000 ⁇ g, optionally about 100 ⁇ g to about 1500 ⁇ g, further optionally about 150 to about 1000 ⁇ g, still optionally about 200 to about 800 ⁇ g, and still further optionally about 200 to about 400 ⁇ g.
  • the present recombinant interferon is administered via intrapleural, abdominal and/or pericardial administration once every about 1 day to about 10 days, optionally once every about 1 day to about 7 days such as every about 1, 2, 3, 4, 5, 6, or 7 days.
  • the perfusion lasts at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject; or the duration can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about 9 months and the like.
  • the single dose of the recombinant interferon can be about 6 ⁇ g to about 100 ⁇ g, optionally about 10 ⁇ g to about 40 ⁇ g, and further optionally about 20 ⁇ g to about 40 ⁇ g.
  • the present recombinant interferon is administered by spray administration about 1 to about 6 times such as about 1, 2, 3, 4, 5, or 6 times per day.
  • the spray lasts at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, about 6 years and the like, or the recombinant interferon can be administered for a long time, including over the life time of the subject; or the duration can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about 9 months and the like.
  • the present recombinant interferon can be administered to the subject about 1, 2, 3, 4, 5, 6, 7, 8, or more times per day, or the present recombinant interferon can be administered to the subject once at the time interval of every about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or 21 days, every month, every 2 months, or a longer time.
  • the present recombinant interferon can be administered to the subject once at the time interval of every about 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, every 2 weeks, every 3 weeks, every month, every 2 months, every 3 months, every half year, every 1 year, or a longer time.
  • the present recombinant interferon is administered in one or more treatment cycles.
  • the more cycles can be 2, 3, 4, 5, 6, 7, 8, 9, 10, or more treatment cycles.
  • duration of the one treatment cycle is at least about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, about 6 years and the like, or the duration can also be about 1 day to about 6 years, about 1 week to about 4 years, about 2 weeks to about 3 years, about 1 month to about 1 year, or about 2 months to about 9 months and the like.
  • the present recombinant interferon can be administered for a long
  • the present recombinant interferon could be administered in more treatment cycles.
  • the treatment cycles are 2 or more treatment cycles.
  • the duration of the multiple treatment cycles may include over the life time of the subject.
  • the time intervals of any two adjacent treatment cycles in all the treatment cycles can be the same or different.
  • the time intervals can be at least about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, about 6 years and the like; or the time intervals can be about 2 days to about 6 years, about 4 days to about 3 years, about 1 weeks to about 1 years, about 2 months to about months, about 3 months to about 6 months and the like.
  • the present recombinant interferon when the present recombinant interferon is administered more times in one treatment cycle, the present recombinant interferon can be administered for one or more times in a smaller dose, then the present recombinant interferon is administered for one or more times in an increased or gradually-increased dose.
  • the present recombinant interferon when the present recombinant interferon is systemically administered via subcutaneous, intramuscular administration (such as subcutaneous, intramuscular injection), the present recombinant interferon can be administered once at a smaller dose such as about 4.5 ⁇ g or 9 ⁇ g, then the recombinant interferon can be administered for more times in an increased (such as to be about 15 ⁇ g, about 18 ⁇ g, about 21 ⁇ g) or gradually-increased dose. In embodiments, the present recombinant interferon is administered once every about 1 day to abut 2 days.
  • the duration for administration of the present recombinant interferon is about 1 week to about 2 years, optionally about 2 weeks to about 1 year, or further optionally about 1 month to about 9 months, including about 2 months to about 6 months, or over the life time of the subject.
  • the gradually-increased administered dose can be about 110% to about 500% of the previously administered dose sequentially.
  • a smaller dose of the present recombinant interferon (such as about 4.5 ⁇ g or about 9 ⁇ g) can be administered, followed by about 12 ⁇ g to about 18 ⁇ g (such as about 13.5 ⁇ g, about 15 ⁇ g, about 18 ⁇ g), and then about 15 ⁇ g to about 30 ⁇ g (such as about 18 ⁇ g, about 21 ⁇ g, about 25.5 ⁇ g, about 30 ⁇ g), once every about 2 days, and for about 2 months to about 3 years, or over the life time of the subject.
  • the recombinant interferon can be administered one or more times at an induction dose, and then one or more times at a therapeutic dose.
  • the induction dose is about 2 ⁇ g to about 10 ⁇ g each time, optionally about 4 ⁇ g to about 10 ⁇ g each time, further optionally about 4.5 ⁇ g to 9 ⁇ g each time, for example, about 4.5 ⁇ g each time or about 9 ⁇ g each time.
  • the therapeutic dose is about 10 ⁇ g to about 70 ⁇ g each time, optionally about 12 ⁇ g to about 50 ⁇ g each time, further optionally about 12 ⁇ g to about 30 ⁇ g each time.
  • the induction dose is about 4 ⁇ g to about 10 ⁇ g each time, and the therapeutic dose is about 12 ⁇ g to about 50 ⁇ g each time. In some embodiments, the induction dose is usually lower than the therapeutic dose. In some embodiments, the time interval between administration of the induction dose and the therapeutic dose is about 1 day to about 1 month, optionally about 1 day to 1 week, further optionally about 1 day to about 3 days, including, for example, about 1 day, about 2 days, about 3 days, about 4 days, about 5 days, about 6 days, about 7 days, about 8 days, about 9 days, about 10 days, about 1 week, about 2 weeks, about 3 weeks and about 1 month.
  • the induction dose when administered more times, it is administered once every about 1 day to about 10 days, optionally every about 1 day to about 7 days, further optionally every about 1 day to about 2 days, including, for example every about 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 days.
  • the therapeutic dose when the therapeutic dose is administered more times, it is administered once every about 1 day to about 10 days, optionally every about 1 day to about 7 days, further optionally every about 1 day to about 2 days, including, for example, every about 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 days.
  • the total administration time of the induction and therapeutic dose should last at least about 1 week, about 2 weeks, about 3 weeks, about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, about 6 years and the like, o or the recombinant interferon can be administered for a long time, including over the life time of the subject.
  • the treatment has reduced the tumor size of the subject, for example, by about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 95%, or about 100% or more, or even completely eliminate the tumor, according to the tumor size at the beginning of treatment.
  • the treatment has reduced the number of cancer cells in tumor, malignant pleural effusion, malignant ascites and/or malignant pericardial effusion of the subjects, for example, by about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 95%, about 100% or more, or even the number of cancer cells is zero, according to the number of cancer cells at the beginning of treatment.
  • the treatment has inhibited (including reduced to some degree and/or terminated) the infiltration of tumor cells into peripheral organs; inhibited or prevented tumor metastasis, such as the in-situ or distant metastasis of tumors, or micrometastasis of tumors; reduced the size of the lesions; brought about downstaging of tumor; and also inhibited or killed micrometastasis in the blood and lymphatic channels; thereby allowing complete resection of initially unresectable tumors or helping to resect tumor which is capable of being resected, such resection is for example a surgical resection.
  • the method it can be a “neoadjuvant method” or an “introducing method”.
  • neoadjuvant method or “introducing method” refers to a therapy given prior to surgery, the goal of the therapy is to reduce the size of the lesions, bring about downstaging of tumor, inhibit or kill micrometastases in the blood and lymphatic channels, reduce the tumor size thereby allowing more conveniently resect tumors or completely resect of initially unresectable tumors.
  • the present recombinant interferon can be further administered to the subject to prevent recurrence and/or metastasis of the tumors after resection of the tumors.
  • the method has reduced or eliminated malignant pleural effusion, malignant ascites and/or malignant pericardial effusion, for example, by about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 95%, about 100% or more, or even completely eliminated malignant pleural effusion, malignant ascites and/or malignant pericardial effusion, according to the volume of malignant pleural effusion, malignant ascites and/or malignant pericardial effusion at the beginning of treatment.
  • the method for preventing recurrence of tumor has reduced the possibility of tumor recurrence after the subject with tumors received treatment.
  • the subject with tumors has been identified and treated prior to administration of the present recombinant interferon (rSIFN-co); such treatments may be the method with the present recombinant interferon, or one or more other different anti-cancer therapies such as chemotherapy, radiotherapy, surgical therapy, interventional therapy, biotherapy, gene therapy, ablation therapy, immunotherapy, targeted therapy, traditional Chinese medicine therapy or any combination thereof.
  • the treatment results can be clinical or basic healing.
  • such preventive therapies can inhibit or eliminate possible micrometastasis in the blood channel and lymphatic channel, so as to prevent recurrence and/or metastasis of the tumor, such micrometastasis can or cannot be clinically detected.
  • the present recombinant interferon could delay the growth of tumor in the subject, for example, by about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 95% or more, according to the tumor growth speed at the beginning of the treatment.
  • the present recombinant interferon is administered to the subject as monotherapy.
  • further comprising one or more other anti-cancer therapies administered to the subject optionally, other anti-cancer therapies are administered to the subject before, simultaneously, and/or after administration of the recombinant interferon.
  • the other anti-cancer therapies comprise one or more of: chemotherapy, radiotherapy, surgical therapy, interventional therapy, biotherapy, gene therapy, ablation therapy, immunotherapy, targeted therapy, and traditional Chinese medicine therapy.
  • the other anti-cancer therapies comprise one or more of chemotherapy, radiotherapy, surgical therapy, targeted therapy, and biotherapy.
  • the other anti-cancer therapies comprise chemotherapy, radiotherapy, or both.
  • the other anti-cancer therapies comprise chemotherapy such as first-line chemotherapy, for example, chemotherapeutic drugs and/or chemotherapeutic protocols comprising platinum compounds, such as Cisplatin.
  • chemotherapeutic drugs used in the chemotherapy combined with the present recombinant interferon include but not limited to platinum compounds such as Cisplatin, Carboplatin, Eloxatin and the like; Paclitaxel compounds such as Docetaxel (Docetaxel Injection, Taxotere) and the like; cytidine antimetabolite such as Gemcitabine (Gemzar) and the like; antifolic antimetabolite such as Pemetrexed (Alimta) and the like; pyrimidine antimetabolite such as Capecitabine (Xeloda) and the like; as well as any combination of the chemotherapeutic agents.
  • platinum compounds such as Cisplatin, Carboplatin, Eloxatin and the like
  • Paclitaxel compounds such as Docetaxel (Docetaxel Injection, Taxotere) and the like
  • cytidine antimetabolite such as Gemcitabine (Gemzar) and the like
  • antifolic antimetabolite such as
  • the following chemotherapy protocols are used, including but not limited to chemotherapy protocols containing platinum compounds, such as GP, TP, EP, GP-T2 protocols and the like.
  • the chemotherapy protocol applied in conjunction with the present recombinant interferon includes Cisplatin nebulized inhalation, Cisplatin pericardial perfusion and the like.
  • the targeted drugs used in the targeted therapy combined with the present recombinant interferon include but not limited to Gefitinib, Erlotinib and/or recombinant human endostatin and the like.
  • other anti-cancer therapies applied in combination with the present recombinant interferon include any combination of the chemotherapeutic drugs/chemotherapy protocols and targeted drugs.
  • other anti-cancer therapies applied in combination with the present recombinant interferon include GP protocol combined with recombinant human endostatin, EP protocol combined with Cisplatin nebulized inhalation and the like.
  • the method of the present invention is a non-surgical therapy.
  • the tumor lesions are divided into measurable lesions and un-measurable lesions, wherein the measurable lesions are defined as target lesions; the longest diameter represents the size of each lesion; at most 5 lesions can be selected in each involved organ, the sum of the measured lesions of all the involved organ is not more than 10, and the sum of the longest diameters of all the lesions is the overall diameter of the target lesion.
  • the un-measurable lesions are defined as non-target lesions, only the existence of the lesions are recorded and tracked, but the sizes of the lesions are not measured.
  • the curative effect evaluation standard of the target lesion is divided into 4 grades, the curative effect evaluation standard of the non-target lesion is divided into 3 grades, and the overall curative effect evaluation is obtained by combining the curative effects of the two kinds of lesions. It is specifically described as follows:
  • the curative effect evaluation standard of the target lesions (1) CR (complete remission): all the target lesions disappear; (2) PR (partial remission): the overall diameter of the target lesions is decreased by more than 30%; (3) NC or SD (no change or stable disease): the target lesions are neither decreased to “PR” nor increased to “PD”; and (4) PD (progression disease): the overall diameter of the target lesions is increased by more than 20%, or one or more new lesions appear.
  • the curative effect evaluation standard of the non-target lesion (1) CR: all the non-target lesions disappear, and the tumor marker level is normal; (2) IR (incomplete response)/SD: one or more non-target lesions is/are not changed, and/or the tumor markers exceed the normal limit; and (3) PD: one or more new lesions appear, and/or the non-target lesions are obviously developed.
  • the recombinant interferon has the beneficial effects as follows:
  • the recombinant interferon rSIFN-co used in the present invention has obvious different structural features and physiological activities compared with the existing interferons such as INFERGEN® (interferon alfacon-1) of the US Amgen.
  • the recombinant interferon can be singly used and/or can be combined with radiotherapy, chemotherapy, biological agents, and/or targeted drugs and the like, so as to non-surgically eliminate or reduce the tumors of the solid tumor subjects, particularly advanced tumors; specifically, the recombinant interferon can eliminate or reduce the solid tumors without indications for surgery, particularly the advanced solid tumors without indications for surgery.
  • the recombinant interferon can be singly administered through topical or local administration such as intratumoral injection/epidermal spray administration and the like, or through the combination of the topical or local administration together with the systemic administration (using the present recombinant interferon or radiotherapy/other anti-tumor drugs and the like), so as to non-surgically (namely, without surgery) eliminate or reduce the solid tumors.
  • topical or local administration such as intratumoral injection/epidermal spray administration and the like
  • systemic administration using the present recombinant interferon or radiotherapy/other anti-tumor drugs and the like
  • the recombinant interferon has obvious effect in replacing the chemotherapy drugs for preventing post-surgery recurrence or metastasis of the tumors, particularly various metastatic lesions such as bone metastasis which cannot be eliminated by existing treatment means; however, drugs can be directly administered to the lesions by the present invention, especially by the topical or local administration, to obviously reduce or eliminate the tumors.
  • the recombinant interferon can be singly administered through intrapleural or abdominal perfusion so as to for effectively eliminate or decrease malignant pleural effusion and/or malignant ascites.
  • cancer can be controlled by the rSIFN-co combination therapy.
  • the present recombinant interferon rSIFN-co
  • rSIFN-co has broad-spectrum anti-tumor effects, which is effective on both solid tumors and non-solid tumors while, at the same time, rSIFN-co has a good synergetic effect with existing treatment means such as surgical therapy, chemotherapy, radiotherapy, biotherapy and other anti-tumor drugs.
  • rSIFN-co has low toxicity which means no harm to normal cells has been observed when rSIFN-co is used in large doses.
  • rSIFN-co is convenient to use and can be directly applied to tumors in any position.
  • the rSIFN-co can be used by subcutaneous/intramuscular injection to control systemic progress of tumor, by intrapleural/abdominal perfusion to eliminate effusion and intrapleural/abdominal tumors, by topical or local injection to eliminate primary or metastatic tumors, and by infiltration (transdermal) administration to treat tumor lesions in bone, skin, muscle, prostate and the like; and rSIFN-co can also be administered by aerosol inhalation. According to above three advantages of rSIFN-co, effective rate of the combination therapy is no lower than 90%.
  • rSIFN-co can be used after surgery to replace chemotherapy and effectively prevent recurrence and metastasis; with regard to advanced cancer cases or cancer cases without indications for therapy, rSIFN-co can be used to eliminate tumors without surgery; with regard to cases without indications for surgery, rSIFN-co can be used to transformed the cases into ones with indications for surgery, thereby creating surgical conditions. Therefore, we believe the rSIFN-co combination therapy is capable of curing cancer.
  • the present invention provides a method for eliminating or reducing the malignant pleural effusion, malignant ascites, and/or malignant pericardial effusion in a subject with tumor, the method comprises administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the tumor is a solid tumor.
  • the recombinant interferon is administered to the subject by an administration route comprising one or more of: infiltration administration, intrapleural administration, abdominal administration, pericardial administration, thoracic administration and intraperitoneal administration.
  • the recombinant interferon is administered in an amount in a range of about 30 ⁇ g to about 2000 ⁇ g by one administration.
  • the recombinant interferon is additionally administered to the subject by systemic administration.
  • the subject is administered with at least one other anti-cancer drug.
  • the other anti-cancer drug is chemotherapeutic drug, targeted drug, or biological drug.
  • the present invention provides a method for preventing tumor recurrence or metastasis, or prolonging or maintaining a tumor-free status in a subject with a tumor, the method comprises administering to the subject a recombinant interferon encoded by the nucleotide sequence SEQ ID NO: 2, and the subject has been treated with at least one anti-cancer therapy before the administration of said recombinant interferon.
  • the anti-cancer therapy is chemotherapy, radiotherapy, surgical therapy, interventional therapy, biotherapy, gene therapy, ablation therapy, immunotherapy, targeted therapy, or traditional Chinese medicine therapy.
  • the recombinant interferon is administered to the subject in a single dose of the range of about 2 ⁇ g to about 2000 ⁇ g.
  • the present invention provides a method for eliminating or reducing metastatic tumor lesion in a subject, the method comprises administering a recombinant interferon encoded by SEQ ID NO: 2 topically or locally to the tumor lesion.
  • the metastatic tumor lesion comprises at least one of a bone lesion, a muscular lesion, a subcutaneous tissue lesion, a prostatic lesion, and a lymph node lesion.
  • the recombinant interferon is administered to the lesion by an administration route comprising at least one of infiltration administration, percutaneous administration, transdermal administration, epidermal administration and transmucosal administration. In another embodiment, the recombinant interferon is administered topically. In another embodiment, the recombinant interferon is further administered systemically.
  • the present invention provides a non-surgical method for eliminating a tumor in a subject or reducing the size of a tumor in a subject, the method comprises administering to the subject a recombinant interferon encoded by SEQ ID NO: 2.
  • the tumor is a non-resectable tumor.
  • the recombinant interferon is administered to the subject by at least one of systemic administration, local administration, and topical administration.
  • the local administration or topical administration comprises one or more of intratumoral administration and spray administration.
  • the subject is administered at least one other anti-cancer therapy.
  • the anti-cancer therapy is chemotherapy, radiotherapy, surgical therapy, interventional therapy, biotherapy, gene therapy, ablation therapy, immunotherapy, targeted therapy, or traditional Chinese medicine therapy.
  • the present invention provides a method for treating lung cancer in a subject, the method comprises administering to the subject a recombinant interferon encoded by SEQ ID NO: 2, and the recombinant interferon is administered to the subject by at least one of systemic administration, topical administration, and local administration.
  • the recombinant interferon is administered systemically and via inhalation.
  • the systemic administration comprises at least one of subcutaneous administration and intramuscular administration
  • inhalation comprises at least one of: pulmonary inhalation and nasal inhalation.
  • the recombinant interferon is administered locally by perfusion.
  • the at least one other anti-cancer therapy is administered to the subject before, simultaneously, and/or after administration of the recombinant interferon.
  • Preparation procedures raw materials were weighed by the ingredients and dissolved by sterile and pyrogen-free water for injected; then filtered by a membrane of 0.22 ⁇ m pore diameter for sterilization, and preserved at 6-10° C.; the materials were sampled for sterile and pyrogen inspections and then separately loaded in vials after qualified inspections, each with a single dose of 0.3-0.5. And then, the materials were put into freeze dryer for freezing and drying.
  • Preparation procedures raw materials were weighed by the ingredients and dissolved by sterile and pyrogen-free water for injection; then filtered by a membrane of 0.22 ⁇ m pore diameter for sterilization, and preserved at 6-10° C.; the materials were sampled for sterile and pyrogen inspections and then separately loaded in sealed containers after qualified inspections, each with a single dose of 0.3-0.5. And then, the finished product were preserved at 2-10° C. in dark places.
  • the ingredient content percentages in the table below are based on weight percentages.
  • the preparation method refers to conventional preparation method of spray.
  • the recombinant interferon inhalant of the present invention was prepared according to conventional preparation methods of interferon inhalant.
  • Table 2 Summary of Clinical Treatment of Multiple Types of Cancers in 58 Patients
  • rSIFN-co therapy began on From April 20, Year The size of PR lung began at January, Year 1: April 14, Year 1. Intramuscular 1 to September 3, the primary adenocarcinoma Taxotere and Carboplatin. injection of rSIFN-co was done once Year 1, Endostar ⁇ circle around (5) ⁇ lesions on One cycle of 21 days was every other day: 9 ⁇ g for the 1st was administrated upper lobe of provided. time, 15 ⁇ g for the 2nd time, 18 ⁇ g every day: 7.5 mg/m 2 right lung for the 3rd time and 21 ⁇ g for the 4th per dose, reduced from time and thereafter.
  • Intramuscular Gamma knife lesion of injection of rSIFN-co was done once radiotherapy for the about every other day: 9 ⁇ g for the 1st brain lesions was 5.1 ⁇ 3.2 cm on time, 18 ⁇ g for the 2nd time and conducted. the upper lobe 21 ⁇ g for the 3rd time and thereafter. of right lung Aerosol inhalation of rSIFN-co was disappeared. simultaneously performed: The enlarged 200 ⁇ g/every other day. lymph nodes From July 14, Year 1, 18 ⁇ g of in the rSIFN-co was used in intramuscular mediastinum injection. Aerosol inhalation of and the 400 ⁇ g of rSIFN-co was metastatic simultaneously performed every lesions in the other day.
  • Intramuscular lesions of left lung injection of rSIFN-co was about performed once every other day: 2.0 ⁇ 2.0 cm in 18 ⁇ g for 1st time, 21 ⁇ g for 2nd time left lung and thereafter. Such administration basically continued for almost 1 year till disappeared March, Year 2. and malignant Intrapleural perfusion of rSIFN-co pleural was done once every 8 days from effusion April 29, Year 1: 9 ⁇ g ⁇ 4 vials for 1st disappeared. and 2nd time and 9 ⁇ g ⁇ 5 vials for 3rd time. Three perfusions were provided totally. Four CT-guided interventional operations were performed in July and August Year 2.
  • the rSIFN-co was injected into relatively large lesions in lungs and 21 ⁇ g ⁇ 10 vials were used each time.
  • An aerosol CHOP (11) around mesenteric times of CHOPE regimen preparation of rSIFN-co (72 ⁇ g/ml) chemotharepy were nasopharynx lymph nodes and two times of MTX was sprayed onto the nasopharynx provided from July and regimen) began on August, Year 1.
  • quincunx 15 ⁇ g ⁇ 10 vials per due to at Chemotherapy was treatment. Two times later, local myelosuppression. submaxillary administered 6 times (3 subcutaneous injection was region, neck times of large-dosed performed every other day: 30 ⁇ g per and clavicular CHOPE regimen, 2 times treatment. Till August 27, Year 3 region shrank of CMOP regimen and 1 (more than 2 months), for a total of from 7.4 cm ⁇ time of a regimen of 10 times.
  • 2.4 cm ⁇ “bleomycin + CHOP (11) + 14.6 cm to Methotrexate”) began on 1.1 cm ⁇ January, Year 3, in 1.5 cm. combination with stem cell therapy.
  • the second course was performed from December Year 2 to July Year 3 during which intramuscular injection was done every other day with 21 ⁇ g per dose.
  • the third course was performed from February 21, Year 4 to May 21, Year 4 during which intramuscular injection was done every other day with 18 ⁇ g per dose.
  • 14 Male 44 Non small cell IIIb Upper lobe of right lung Treatment of rSIFN-co began on After surgery, CR lung cancer was resected on October November 6, Year 1. Intramuscular no tumor (poorly 20, Year 1. injection of rSIFN-co was recurrence or differentiated administered once every other day: metastasis adenocarcinoma) 18 ⁇ g for 1st time, 21 ⁇ g for 2nd time was found at and thereafter.
  • Intramuscular injection of rSIFN-co was provided every other day with 15 ⁇ g per dose.
  • Intramuscular injection of rSIFN-co and Aerosol inhalation were administered for 3 months from November Year 4.
  • Intramuscular injection was done once every other day with 15 ⁇ g per dose. Aerosol inhalation was performed every day and a total of 300 ⁇ g was used for one day.
  • 15 Male 68 Lung cancer IV Treatment with Gamma Treatment of rSIFN-co began on Mass of about PR with systemic Knife was done under local June 25, Year 3.
  • the rSIFN-co was 11.3 ⁇ 4.9 cm in metastases anesthesia on April 27, Year injected into lymph nodes of groin pelvic cavity 3. Intramuscularly every day: 15 ⁇ g ⁇ 6 reduced in Sr-89 therapy was done by vials for 1 st time, 15 ⁇ g ⁇ 8 vials for size to Nuclear Medicine 2nd time and 15 ⁇ g ⁇ 10 vials for 3rd 7.52 ⁇ 7.67 ⁇ Department on April 30, time and thereafter. Eleven 6.72 cm Year 3.
  • lymph nodes combined with 15 mg of Endostar on day once every other day: 9 ⁇ g for 1st at bilateral bone 1 ⁇ 10 and 200 mg of time, 15 ⁇ g for 2nd time, 18 ⁇ g for shoulder metastases at temozolomide on day 1 ⁇ 5, 3rd time and thereafter. Meanwhile, joints and bilateral hip oral administration.
  • the drug was locally applied by axillae joints, bilateral Targeted radiotherapy spraying onto the skin surface of the disappeared; femurs, (50Gy/25f) was done on right shouder: 70 ⁇ g- recurrence bilateral November 2, Year 1 and the 139 ⁇ g/dose/site, 4-5 doses/day. and metastatic humeri, ribs targets were right maxillary Spraying was provided to skin lesions at and bilateral sinus + 1 ⁇ 4 of the left surface of the left shoulder and other residual right shoulder joints.
  • liver metastases was eliminated, surgery of the lower left performed on March while no lung cancer was performed 17, Year 2. apparent on January 6, Year 2. Hepatic local change in Radiofrequency ablation of perfusion of liver the liver metastases was “Paclitaxel + metastases performed on January 13, Carboplatin” was was observed. Year 2. performed on April 21, Year 2.
  • Lung tumor PR treatments were performed rSIFN-co began on July 9, Year 2; shrunk, and in March, April and May of Intramuscular injection once every swollen Year 1; Began taking other day: 9 ⁇ g for the 1st time, lymph nodes Gefitinib on June 10, Year 1. 13.5 ⁇ g for the 2nd time, and 18 ⁇ g disappeared. for the 3rd time and thereafter; Aerosol inhalation of 300 ⁇ g per day.
  • Perfusion of rSIFN-co at 21 ⁇ g ⁇ 5 vials once every 6-8 days began on September 22, Year 2, depending on the subject's pleural effusion level and tolerance.
  • Perfusion of rSIFN-co at 21 ⁇ g ⁇ 6 to 8 or 10 vials once every 4 days began on October 21, Year 2, depending on the subject's pleural effusion level and tolerance.
  • rSIFN-co began on March 17, Year ablation targeting of colon, with Six chemotherapy 4; right lung metastases lung treatments had been Intramuscular injection once every was performed on metastases performed from May Year other day: March 28, Year 4; after surgery 1 to September Year 1, with 9 ⁇ g for the first time, Argon-helium the regimen of XELOX, 21 ⁇ g for the second time and cryosurgery targeting capecitabine tablets thereafter.
  • Radiofrequency Oxaliplatin 150 mg ablations targeting intravenous drip, QD, d1; left lung metastases cetuximab 600 mg, were performed 2 intravenous drip, QD, d1; times on May 5, Year irinotecan 240 mg, 4and June 13, Year 4, intravenous drip, QD, d2; respectively; fluorouracil 2500 mg, The right lower lung continuous intravenous drip metastases were for 48 hours; treated by ion TCM treatment had been implantation on May performed from November 27, Year 4. Year 2 to August Year 3. 2 courses of chemotherapy in December Year 4: capecitabine tablets 3000 mg, oral, d1-d14. Systemic chemotherapy on March 9, Year 5, cetuximab + alimta.
  • Avastin and NK cells were added for treatment on March 23, Year 5. Radiotherapy of hepatic metastases from April 21, Year 5 to May 19, Year 5. 41 Male 57 Colon cancer IV Hepatic interventions were Treatment by administering NC/SD with hepatic performed 2 times in rSIFN-co began on September 30, Year 1; metastases August Year 1 and on Intramuscular injection once every September 12, Year 1, other day: respectively.
  • the 3rd TACE was performed on August 2, Year 2.
  • Argon-helium cryoablation targeting multiple intrahepatic lesions was performed in September Year 2.
  • the 2nd argon-helium cryoablation was performed on November 7, Year 2.
  • Wedge resection of rSIFN-co began on September 5, Year 4; metastases left lung superior lobe
  • Intramuscular injection of 9 ⁇ g every masses was performed on other day from September 5, Year 4 July 6, Year 4. to September 9, Year 4.
  • Intramuscular injection of 9 ⁇ g at the 1st time Intramuscular injection of 18 ⁇ g from the 2nd time and thereafter.
  • Intramuscular injection of 9 ⁇ g at the radiotherapy was lesions were Radiofrequency ablation 1st time; Intramuscular injection of performed 24 times, eliminated or targeting a large pelvic 21 ⁇ g from the 2nd time and beginning December shrank. lymph node was performed thereafter; 12, Year 1 (60Gy on June 26, Year 1. Intraperitoneal perfusion, 7 times, 2.5 ⁇ 24 times).. I-125 particle implantation 21 ⁇ g ⁇ 8 vials each time. was performed on July 18, Year 1. 54 Female 46 Gastrointestinal Ib Duodenal tumorectorny Treatment by administering No signs of CR stromal was performed on July 13, Year 1. rSIFN-co began on December Year apparent tumors Radiotherapy was 1.
  • Non-small-cell lung cancer the primary lesions in the right pulmonary hilum and the mediastinal lymph node metastasis disappeared after treatment by intramuscular injection of recombinant super-compound interferon (rSIFN-co) in combination with radiotherapy.
  • rSIFN-co super-compound interferon
  • Patient 1 Gender Male Age: 53
  • Pathological diagnosis Squamous cell carcinoma Clinical and pathological staging ⁇ circle around (1) ⁇ : T 3 N 2 M 0.
  • Regimens before administration of DP Regimen ⁇ circle around (8) ⁇ was provided from October 14, rSIFN-co: Year 1 to November 25, Year 1: 75 mg of Taxotere and 75 mg of Cisplatin on Day 1. Two cycles of chemotherapy were performed in total, each lasting for 21 days.
  • Regimens administration of rSIFN-co The rSIFN-co therapy started in November, Year combined with radiotherapy 1.
  • Intramuscular injection of rSIFN-co was done once every other day: 9 ⁇ g for the 1st time, 15 ⁇ g for the 2nd time and 18 ⁇ g for the 3rd time and thereafter. Therapy continued till February, Year 3, during which rSIFN-co treatment had been stopped for 1 month in April, Year 2, leading to a total treatment duration of 15 months.
  • Non-small-cell lung adenocarcinoma with systemic metastases on body parts including bilateral lungs, liver and lymph nodes/Intramuscular injection and aerosol inhalation of rSIFN-co combined with chemotherapy (GP regimen) and administration of recombinant human endostatin (Endostar).
  • GP regimen chemotherapy
  • Endostar recombinant human endostatin
  • Patient 2 Gender Male Age: 40 Pathological diagnosis: Lung Adenocarcinoma Clinical and pathological staging ⁇ circle around (1) ⁇ : T 3 N 3 M 1.
  • IV Regimens before administration of Systematic chemotherapy began at January, Year rSIFN-co: 1: Taxotere and Carboplatin. One cycle of 21 days was provided.
  • rSIFN-co aerosol inhalation of rSIFN-co was done once every day: 300 ⁇ g for the 1st time, 500 ⁇ g for the 2nd time, 600 ⁇ g for the 3rd time and thereafter.
  • Administration of rSIFN-co ended in April Year 2. From April 20, Year 1 to September 3, Year 1, Endostar 5 was administrated every day: 7.5 mg/m 2 per dose, 1.2 ⁇ 10 ⁇ circle around (5) ⁇ U/m 2 . Four cycles were performed totally with each lasting for 14 days. Meanwhile, GP regimen was combined: 1600 mg of Gemcitabine on days 1 and 8 and 40 mg of Cisplatin on days 1 ⁇ 3. Four cycles were performed, each being 15 days.
  • Cisplatin One intrapericardial infusion with Cisplatin (30 mg) was performed on July 19, Year 1. Aerosol inhalation of Cisplatin was added from December 23, Year 1 to January 14, Year 2: 10 mg/dose, 2 doses per day. The second course of Endostar treatment was provided from January 18, Year 2 to January 30, Year 2 with same dosage. Chemotherapy using Pemetrexed ⁇ circle around (6) ⁇ proceeded from December 25, Year 1 to January 19, Year 2: iv. 500 mg/m 2 , every 3 to 4 weeks.
  • Patient 3 Gender Female Age: 51 Pathological diagnosis: None Clinical and pathological staging ⁇ circle around (1) ⁇ : T 2 N 2 M 1 .
  • IV Regimens before administration of None rSIFN-co Regimens: administration of rSIFN-co Treatment with rSIFN-co started on May 29, combined with Gamma knife treatment Year 1.
  • Intramuscular injection of rSIFN-co was done once every other day: 9 ⁇ g for the 1st time, 18 ⁇ g for the 2nd time and 21 ⁇ g for the 3rd time and thereafter. Aerosol inhalation of rSIFN-co was simultaneously performed: 200 ⁇ g/every other day.
  • Irregular increased density shadows were found about 5.1 ⁇ 3.2 cm was found at the apex of at upper lobe of right lung near mediastinum, right lung, which had an obscure suggesting the possible occurrence of boundary and connected to anterior inflammation in the right lung.
  • the thorax was pleural membrane. Enlarged lymph nodes symmetrical, and the perivascular space in were found in neighboring mediastinum. mediastinum was clear with no enlarged lymph Diagnostic imaging showed that it was a node found. (See the original location of the space-occupying lesion in the apex of lesions indicated by arrow in FIG. 5b) right lung. 2.
  • Irregular low-density shadows could be seen in Brain CT scans on May 14, Year 1 (see the right frontal lobe and left temporal lobe.
  • FIGS. 5a-5b After 3-month of treatment, the mass at the apex of right lung completely disappeared.
  • chemotherapy anerosol inhalation of Cisplatin and EP regimen
  • interventional therapy for supraclavicular lesions.
  • Patient 4 Gender Male Age: 49 Pathological diagnosis: Small-cell lung cancer Clinical and pathological staging ⁇ circle around (1) ⁇ : T 4 N 3 M 1 .
  • IV Regimes before administration of rSIFN-co The first cycle of EP ⁇ circle around (7) ⁇ chemotherapy was conducted from March 25, Year 1 to Apr 9, Year 1: 100 mg of Etoposide and 30 mg of Cisplatin.
  • Regimes administration of rSIFN-co The treatment of rSIFN-co began on April 12, combined with chemotherapy and Year 1. Intramuscular injection was done interventional therapy once every other day: 9 ⁇ g for the 1st time, 15 ⁇ g for the 2nd time and 18 ⁇ g for the 3rd time and thereafter.
  • Aerosol inhalation of rSIFN-co was performed once every other day: 0.5 ⁇ 2 ml/dose (200 ⁇ g/ml). From July 16, Year 1, 21 ⁇ g of rSIFN-co was used in intramuscular injection. Aerosol inhalation of rSIFN-co continued but the amount per dose was changed to 200 ⁇ g. The first cycle finished by the end of March Year 2 (lasting for almost 1 year). The administration of rSIFN-co was stopped for 1 month because Aerosol inhalation of Cisplatin (one dose per day and 10 mg per dose) was performed throughout September Year 1.
  • the 2nd cycle of treatment proceeded from October 9, Year 2 to January 26, Year 3 during which 18 ⁇ g of rSIFN-co was intramuscularly injected every other day.
  • Five cycles of EP chemotherapy were conducted from March 25, Year 1 to September 10, Year 1 and the same regimen as mentioned above was used.
  • An interventional cryoablation was conducted on the supraclavicular lesions on September 3, Year 2.
  • a 15-day regimen of aerosol inhalation of Cisplatin was added: 10 mg per dose, 1 dose per day. Two cycles were done, each lasting for 15 days.
  • rSIFN-co PET/CT scans on April 8, Year 1 (see the PET/CT scans on December 24, Year 1 (see lesions indicated by arrows in FIG. 7a-8a) the original lesion locations indicated by after the chemotherapy: arrows in FIG. 7a-8a): 1.
  • PET showed 2.
  • the nodules on right clavicle were abnormal radioactive concentration and the significantly downsized. PET showed SUV value was 4.1. abnormal radioactive concentration with a 2.
  • Nodules of about 2.6 ⁇ 2.2 cm were SUV value of 4.7; observed at right clavicle, the boundaries of 3. The nodules around the mediastinal which were obscure. PET showed abnormal brachiocephalic trunk, right brachiocephalic radioactive concentration and the SUV value veins, and trachea were not clearly observed. was 9.1. superior vena cava; 3. Multiple nodules of about 5.5 cm ⁇ 4.9 cm 4. Multiple nodules were found around the appeared around the mediastinal superior vena cava. PET did not show an brachiocephalic trunk, right brachiocephalic obvious radioactive concentration, indicating veins, superior vena cava, and trachea. The the suppression on the lesions' metabolism.
  • PET Streaky shadows were found in the upper showed abnormal radioactive concentration lobe of right lung while patchy shadows were and the SUV value was 11.5). Metastasis of found in dorsal segment of lower lobe. PET lymph nodes should be taken into account. scan did not show obvious radioactive 4. The superior vena cava could not be concentration; excluded. 2. After cryotherapy was conducted for the right supraclavicular metastasis, no obvious nodules or masses were found in the right clavicle and PET image did not show obvious radioactive concentration. PET scans on other parts showed similar metabolic images as before.
  • PET/CT on February 7, Year 4 (after treatment of “small-cell cancer of right lung” and compared to PET/CT scans taken on July 26, Year 3): 1.
  • the posterior wall of left nasopharynx was thickened slightly and PET imaging showed radioactive concentration, suggesting the possible occurrence of an inflammatory lesion; 2.
  • Multiple nodules were at deep cervical and submentum and PET imaging did not show abnormal radioactive concentration, suggesting the possible occurrence of inflammatory hyperplasia of lymph nodes; 3.
  • the wall of greater gastric curvature was slightly thickened and PET imaging did not show radioactive concentration. Inflammatory lesion could be taken into consideration; 4.
  • PET/CT scans on other parts did not show significant changes.
  • Description of FIGS. 7a-7b After 8 months of treatment, the lesions on the apex of the right lung disappeared.
  • Description of FIGS. 8a-8b After 8 months of treatment, the metastatic lesions in mediastinum disappeared.
  • Non-small-cell lung cancer with metastases to the right humerus after surgeries/Intramuscular injection and aerosol inhalation of rSIFN-co combined with chemotherapy (aerosol inhalation of Cisplatin). After treatment, the metastatic lesions in right lung hilum, paratracheal lymph nodes and several sites of spinal metastases disappeared.
  • Patient 5 Gender Female Age: 42 Pathological diagnosis ⁇ circle around (1) ⁇ : Metastatic adenocarcinoma (in right humerus) (moderately differentiated adenocarcinoma) Clinical and pathological staging ⁇ circle around (1) ⁇ : T 2 N 2 M 1.
  • IV Regimes before administration of rSIFN-co A surgical repair of right humerus was performed on February 23, Year 1. After that surgery, patient was given 4 courses of DP ⁇ circle around (8) ⁇ chemotherapy: 75 mg of Taxotere and 75 mg of Cisplatin on day 1.
  • Regimes administration of rSIFN-co Treatment with rSIFN-co began on April 15, combined with chemotherapy Year 1.
  • Intramuscular injection was performed once every other day: 9 ⁇ g for the 1st time and 21 ⁇ g for the 2nd time and thereafter.
  • the treatment was provided for a total of 3 months till September 15, Year 1, during which rSIFN-co administration was suspended for 1 month due to chemotherapy (the chemotherapy regimen shown below related to aerosol inhalation of Cisplatin) and for 1 month because of the patient's physical condition.
  • Aerosol inhalation of rSIFN-co was added on September 16, Year 1: 1 ml (200 ⁇ g/ml) per day. Till February, Year 2, the co-administration regimen was provided for 5 months. From September 15, Year 2, intramuscular injection of 15 ⁇ g was provided every other day.
  • Aerosol inhalation of Cisplatin began on September 16, Year 1: 10 mg per dose and 2 doses per day. Eight cycles were conducted with each cycle being 15 days.
  • Response to rSIFN-co treatment CR ⁇ circle around (2) ⁇ (radioactive concentrations at the primary lesion of right lung tumor, right humerus and the T6 vertebra evidently decreased. Metastatic lesions on pelvis and lumbar vertebrae as well as enlarged paratracheal lymph nodes disappeared.) Survival: After about 40 months (February Year 1 to July Year 4), the patient remained alive with a normal life. No recurrence or metastasis was observed upon imaging.
  • rSIFN-co PET/CT scans on February 26, Year 1 after PET/CT scans on March 2, Year 2 (see original surgery (See lesions indicated by arrows in locations of lesions indicated by arrows in FIG. FIG. 9a-11a): 9b-11b): 1.
  • the mass on the soft tissue of anterior 24 mm ⁇ 19 mm ⁇ 18 mm was found at the front segment of upper lobe of right lung did not end of right lung' upper lobe. change in shape, size and density. The extent of 2.
  • FIGS. 9a-9b After treatment, the radionuclide metabolism reduced significantly in the primary lesions of right lung.
  • Description of FIGS. 10a-10b The radioactive concentration of the lesions at upper segment of right humerus decreased.
  • Description of FIGS. 11a-11b Metastatic lesions on pelvis disappeared.
  • Non-small-cell lung cancer with multiple lymph node metastases in mediastinum, left segment of neck, right and root segment of neck, left supraclavicular fossa; left-sided pleural effusion; multiple bone metastases in vertebral column, bilateral ribs, right clavicle joint, sternum and left sacrum, and obvious generalized pain/Intramuscular injection, aerosol inhalation and local spraying of rSIFN-co combined with chemotherapy (GP regimen) and Gefinitib (Iressa) therapy. After the treatment, primary lesions on left lung disappeared and metastatic lesions around the body shrank. Further, generalized pain was relieved.
  • Intramuscular injection of rSIFN-co started on December 12, Year 1, once every other day: 9 ⁇ g for 1st time, 15 ⁇ g for 2nd time and 18 ⁇ g for 3rd time and thereafter.
  • Local spraying on bone metastases began on March 12, Year 2: 70 ⁇ g ⁇ 139 ⁇ g/does/site, 4 ⁇ 5 doses/day.
  • the second cycle of GP Regimen ⁇ circle around (9) ⁇ started on October 14, Year 1 (the regimen was exactly the same as mentioned above).
  • Gefinitib was taken from November 24, Year 1: 1 pill/dose (250 mg/pill), 1 dose/day.
  • rSIFN-co Chest CT scans on September 21, Year 1 CT scans on November 15, Year 1: (see primary lesions indicated by arrows Shadows of soft tissues of about 3.6 ⁇ 4.2 cm were in FIG. 12a): found; sheet-like density shadows were scattered A blocky shadow (9 ⁇ 3.5 cm) of high and had obscure boundaries; no enlarged lymph density was found around left nodes were seen in the mediastinum (the original mediastinum and CT value was 39Hu. ones disappeared). The boundaries between this shadow and CT scans on December 12, Year 1 (see original part of great vessels in mediastinum locations of lesions indicated by arrows in FIG.
  • pleura were obscure. Patchy shadow of Sheet-like and single-sheet-like shadows with inflammatory exudation with high density increased density were scattered in both lungs. could be seen in lung. Enlarged lymph The boundaries were obscure and two hila were nodes were found in mediastinum. A few not larger. The tracheas were clear and no patchy shadows with high density were enlarged lymph nodes were seen in the seen inhomogeneous in upper segment of mediastinum. Pneumonia of both lungs might right lung, boundaries of which were happen. clear. Arched effusions were found on left Bone scans on December 6, Year 1: posterior side.
  • Diagnosis conclusion lung cancer in left shadows with abnormal radioactive concentration mediastinum combined with pleural could be seen in right sternoclavicular joints, ribs, effusion and obstructive pneumonia; spinal column and pelvis. Radioactive multiple patchy shadows were present in distributions in other parts were basically uniform hilum, suggesting the possible occurrence and symmetrical. of metastases. Diagnosis conclusion: systemic bone metastases Color Doppler ultrasound on September shrank in size and were relieved to some extent 30, Year 1: than before.
  • hypoechoic nodules were at left PET/CT scans on December 29, Year 1: segment of neck, which had clear A nodule with diameter of about 8 mm was boundaries and had no hilum of lymph observed at the apex of left lung and radioactive nodes. The big hypoechoic nodule was distribution was slightly increased. Patchy 1.0 cm ⁇ 0.7 cm in size. One hypoechoic shadows with slightly higher (than normal) nodule of about 1.2 cm ⁇ 0.8 cm was at left density and fabric lesions were found in supraclavicular fossa. It had clear surrounding area of lung and the radioactive boundary but had no hilum of lymph distribution was slight increased. Scattered, node.
  • hypoechoic nodule of about patchy shadows with slightly higher density were 1.4 cm ⁇ 1.1 cm was at root segment of neck found in both lungs and the radioactive on the right side. It had clear boundary distribution was not obviously abnormal. but had no hilum of lymph node.
  • hypoechoic increase of FDG metabolism was found on at nodules were found at left segment of lesions of the apex of left lung, suggesting the neck, left supraclavicular fossa and root inactivation of most tumor cells; 2. Asymmetric segment of neck on the right side.
  • Patient 7 Gender Female Age: 53 Pathological diagnosis: metastatic adenocarcinoma (lymph nodes at left clavicle) Clinical and pathological staging ⁇ circle around (1) ⁇ : T 4 N 3 M 1.
  • IV Regimens before administration of None rSIFN-co Regimens: administration of rSIFN-co Treatment with rSIFN-co began on July 31, Year combined with administration of other 1.
  • Intramuscular injection was done once every biological agents other day: 9 ⁇ g for 1 st time, 18 ⁇ g for 2nd time and 21 ⁇ g for 3 rd time and thereafter. Seventy-five times of intramuscular injection were done till January 2, Year 2 (totally 5 months).
  • Iressa (Gefinitib) ⁇ circle around (10) ⁇ produced in India was administered in combination for 1 year: 1 pill/dose (250 mg/pill), 1 dose/day.
  • Response to rSIFN-co treatment PR ⁇ circle around (2) ⁇ (primary lesions in right lung and metastatic lesions in both lungs and several bones shrank with radioactive concentration decreased; metastasis in liver disappeared.)
  • the disease was diagnosed as lung cancer in CT imaging on July 2, Year 1: July. Specifically, patchy nodular lesions in the see lesions indicated by arrows in FIG. lower lobe of right lung and circumjacent 14a. spot-like shadows with high density were seen. Condition was improved as compared with previous CT scans. 2. The size and shape of liver were normal. Density of liver is even and no focal density abnormality was found. CT scans on March 3, Year 2: Compared with the imaging on October 22, Year 1, no new lesion was found and partial sclerotin radiation was reduced. Multiple bone metastases existed with lung cancer, but improved after treatment. Description of FIGS. 13a-13b: After treatment, systemic metastatic lesions at bones partially disappeared or shrank. Description of FIGS. 14a-14b: After treatment, metastatic lesions in both lungs disappeared and lesions in right lung evidently shrank.
  • Patient 8 Gender Female Age: 68 Clinical and pathological staging ⁇ circle around (1) ⁇ : T 4 N 2 M 1.
  • IV Regimens before administration of None rSIFN-co Regimens: administration of rSIFN-co Treatment with rSIFN-co began on July 21, Year combined with other biological therapies 1
  • Intramuscular injection was done once every other day: 9 ⁇ g for 1st time, 15 ⁇ g for 2nd time and 18 ⁇ g for 3rd time and thereafter. Meanwhile, aerosol inhalation of rSIFN-co of 600 ⁇ g was performed once a day.
  • Administration of rSIFN-co continued for 3 months till October 31, Year 1.
  • a density shadow of soft tissue lung markings increased and disordered and mass (3.0 ⁇ 3.9 cm) was found in lower transmittance of lung field was elevated. Lesions lobe of right lung.
  • Patient 9 Gender Male Age: 55 Pathological diagnosis: Squamous cell carcinoma Clinical and pathological staging ⁇ circle around (1) ⁇ : T 2 N 1 M 0. IIb Regimens before administration of None rSIFN-co: Regimens: rSIFN-co combined with Treatment with rSIFN-co began on March 18, chemotherapy. Year 1. Aerosol inhalation of rSIFN-co of 600 ⁇ g was performed once a day. A course completed till July 20, Year 1 (for 4 months) with 100 doses of aerosol inhalation done.
  • FIGS. 17a-17b After treatment of 4 months, soft tissue masses at hilum of lower lobe of right lung evidently shrank.
  • Non-small-cell lung cancer with metastases in lung and pleura pleural effusion/Intramuscular injection of rSIFN-co alone or intrapleural perfusion of rSIFN-co alone.
  • pleural effusion/Intramuscular injection of rSIFN-co alone or intrapleural perfusion of rSIFN-co alone After treatment, primary lesions on the apical segment of upper lobe of left lung were cleared up and metastatic lesions on lingual segment of left lung shrank.
  • Cytological diagnosis before Cytological diagnosis after administration of administration of rSIFN-co rSIFN-co: Pleural fluid smear (March 2, Year 1): Pleural fluid smear and cell mass (September 18, poorly differentiated cancer cells were Year 1): found. Lymphocytes, neutrophils and necrotic materials were found, no tumor cells was found. Diagnostic imaging before administration Diagnostic imaging after administration of of rSIFN-co: rSIFN-co: Chest CT scans on February 23, Year 1: CT scans on August 1, Year 1 (see original 1. A mass of 2.0 ⁇ 2.0 cm was found at locations of lesions indicated by arrows in FIG. apical segment of the upper lobe of the 19b): left lung, suggesting the possible 1.
  • Non-hodgkin lymphoma/Aerosol inhalation (though nasopharynx and Oral Cavity) of rSIFN-co and local injection into enlarged lymph nodes at neck combined with radiotherapy. After local administration, lesions in the nasal cavity, oropharynx, neck and submaxillary region disappeared or shrank.
  • Chemotherapy was administered 6 times (3 times of large-dosed CHOPE regimen, 2 times of CMOP regimen and 1 time of a regimen of “bleomycin + CHOP (11) + Methotrexate”) began on January, Year 3, in combination with stem cell therapy.
  • chemotherapy and radiotherapy An aerosol preparation of rSIFN-co (72 ⁇ g/ml) was sprayed onto the nasopharynx and Oral Cavity 2 ⁇ 3 times every day. Administration continued till August 27, Year 3 with 5 days of suspension because of chemotherapy (see chemotherapy describebd below). Local injections on lymph nodes in neck started on June 11, Year 3.
  • Injection was performed every other day by injection at multiple sites in a quincunx: 15 ⁇ g ⁇ 10 vials per treatment. Two times later, local subcutaneous injection was performed every other day: 30 ⁇ g per treatment. Till August 27, Year 3 (more than 2 months), for a total of 10 times.
  • Four cycles of CHOP (11) chemotharepy were provided from July Year 3 to November 28, Year 3 with each cycle lasting for 21 days. Radiotherapy began on June 11, Year 3 (scheduled for 25 times) and stopped on July 5, Year 3 as the patient was weak due to myelosuppression.
  • FIGS. 21a-21b After treatment, a large number of primary enlarged lymph nodes at neck disappeared.
  • Description of FIGS. 22a-22b After treatment, primary lesions at bilateral mandible disappeared.
  • Description of FIGS. 23a-23b After treatment, primary lesions at pharyngeal disappeared.
  • Patient 12 Gender Male Age: 67 Cytologic diagnosis: Lung adenocarcinoma Clinical and pathological staging ⁇ circle around (1) ⁇ : T 3 N 0 M 0. II b Regimens before administration of From August 16, Year 1, two cycles of GP rSIFN-co: regimen ⁇ circle around (9) ⁇ were provided: 1000 mg/m 2 of Gemcitabine on day 1 and 8 and 75 mg/m 2 of Cisplatin on day 1. Intrathoracic injection of Cisplatin was also performed for 5 times. 1 dose every 7 days, 30-40 mg per dose. Regimens: administration of rSIFN-co Treatment with rSIFN-co began on November alone 10, Year 1.
  • Intramuscular injection of rSIFN-co was provided once every two days: 9 ⁇ g for 1st time, 18 ⁇ g for 2nd time and 21 ⁇ g for 3rd time and thereafter. Administration lasted for almost 1 year till October 27, Year 2.
  • Response to rSIFN-co treatment PR ⁇ circle around (2) ⁇ (the mass reduced from about 3.1 ⁇ 4.2 cm to 2.2 ⁇ 1.5 cm after 2 months' treatment, and the lesion further reduced in size after administration for 3 months.)
  • Survival about 28 months (from Augugst 11, Year 1 to Year 4) Diagnostic imaging before Diagnostic imaging after administration of administration of rSIFN-co: rSIFN-co: Chest CT scans on October 10, Year 1 CT scans on January 10, Year 2: after chemotherapy: The mass was about 2.2 ⁇ 1.5 cm on lower A shadow of tumor mass of about segment of right hilum which was significantly 3.1 ⁇ 4.2 cm was found at opening segment smaller than before.
  • FIG. 24b Lung tissue was compressed by about After 3 months' treatment, the mass on lower 10% in size and not much pleural effusion segment of right hilum evedently shrank. were seen in right-sided thoracic cavity.
  • Non-small-cell lung cancer after surgeries/Intramuscular injection of rSIFN-co alone. After the treatment, no tumor recurrence or metastasis was found in right lung and the whole body.
  • Patient 13 Gender Male Age: 63
  • Pathological diagnosis poorly differentiated adenocarcinoma (upper lobe of right lung)
  • Clinical and pathological staging ⁇ circle around (1) ⁇ T 4 N 2 M 0.
  • IIIb Regimens before administration of On October 15, Year 1, resection of upper lobe of rSIFN-co: right lung and lymph node dissection were done as well as wedge resection of nodules on lower lobe of right lung.
  • Postoperative pathology report Poorly differentiated adenocarcinoma occured on upper lobe of right lung; the tumor was 4.5 ⁇ 4.5 ⁇ 4 cm in size and grew to regions below visceral pleura.
  • the third course was performed from February 21, Year 4 to May 21, Year 4 during which intramuscular injection was done every other day with 18 ⁇ g per dose.
  • Response to rSIFN-co CR ⁇ circle around (2) ⁇ (After surgery on primary lesions, no tumor recurrence or metastasis occurred.) Survival: After 45 months (from September 13, Year 1 to July Year 5), the patient remained alive and had normal life. No recurrence or metastases was observed on imaging test. Diagnostic imaging before Diagnostic imaging after administration of administration of rSIFN-co: rSIFN-co: CT scans on May 25, Year 3: see the suspicious lesion at lower lobe of right lung indicated by arrows in FIG. 25a. Chest CT scans on February 11, Year 4: 1.
  • FIGS. 25a-25b After treatment, the space occupying at lower lobe of right lung disappeared and no tumor recurrence or metastasis was found.
  • Non-small-cell lung adenocarcinoma after surgery/Intramuscular injection of rSIFN-co alone. After the treatment, no tumor recurrence and metastasis was found.
  • Patient 14 Gender Male Age: 44 Pathological diagnosis: Poorly differentiated adenocarcinoma Clinical and pathological staging ⁇ circle around (1) ⁇ : T 4 N 3 M 0 , IIIb Regimens before administration of Upper lobe of right lung was resected on October rSIFN-co: 20, Year 1. Postoperative pathology report: Examination on October 27, Year 1: (masses at upper lobe of the right lung) part of lung tissue was resected. Alveolar epithelium hyperplasia and chronic inflammatory cell infiltration were observed under microscope. Fibroplasia happened at the side of pleura with collagenization. Focal hemorrhage and necrosis were also observed while poorly differentiated adenocarcinoma was found.
  • Intramuscular injection was done once every other day with 15 ⁇ g per dose. Aerosol inhalation was performed every day and a total of 300 ⁇ g was used for one day.
  • Response to rSIFN-co treatment CR ⁇ circle around (2) ⁇ (after surgery, no tumor recurrence or metastasis was found at primary lesions.)
  • Survival After about 44 months (from October 14, Year 1 to July Year 5), the patient remained alive and had a normal life. No initial recurrence or metastases was observed upon imaging.
  • rSIFN-co Chest CT scans on October 13, Year 1: CT scans on February 22, Year 3 (see the original Peripheral lung cancer was found in surgical site indicated by arrow in FIG. 26b): posterior segment of right upper lobe; the High-density stripe-like shadows were found in tumor of about 4.0 ⁇ 2.9 cm in size grew residual part of upper lobe of right lung and local into posterosuperior segment of bronchiectasia happened, which were mainly right-sided pleura and implantation postoperative changes. No significant change was metastasis happened at right-sided pleura; found in lesions as compared with previous CT.
  • Non-small-cell lung cancer with systemic metastases local injection of rSIFN-co into enlarged lymph nodes in groin. After local injections, metastatic lesions in the lymph nodes in pelvic cavity and inguinal area were cleared up or shrank.
  • the rSIFN-co was injected into lymph nodes of groin Intramuscularly every day: 15 ⁇ g ⁇ 6 vials for 1st time, 15 ⁇ g ⁇ 8 vials for 2nd time and 15 ⁇ g ⁇ 10 vials for 3rd time and thereafter. Eleven injections were done till July 20, Year 3 (Severe diarrhea occurred after 3 injections and administration was stopped for 2 weeks; after that injection was performed every day and 8 injections in total were continuasly provided). Discontinuous local injection in lymph nodes were performed for 6 times from August 18, Year 3 to September 16, Year 3: 15 ⁇ g ⁇ 10 vials for each time.
  • Rectal cancer after a surgery/Intramuscular injection of rSIFN-co alone. After the treatment, no tumor recurrence or metastasis was found.
  • Patient 16 Gender Female Age: 63 Pathological diagnosis: Well to moderately differentiated adenocarcinoma was found in rectum and mucinous adenocarcinoma was found in part of rectum. Cancer invaded into deep muscularis of intestinal wall and formed cancerous nodules in mesorectum (see the cancer cells indicated by arrows in FIG. 28) Clinical and pathological staging ⁇ circle around (1) ⁇ : T 4 N 1 M x . IIIb Regimens before administration of Laparoscopic-assisted abdominal perineal radical rSIFN-co: resection of rectal cancer was done on May 16, Year 1. Regimens: administration of rSIFN-co Treatment of rSIFN-co began on May 23, Year 1.
  • Intramuscular injection of rSIFN-co was provided once every other day: 21 ⁇ g for each time.
  • the first course of 8 months ended on February Year 2.
  • the second course was provided from January Year 3 to April Year 3.
  • Intramuscular injection of rSIFN-co was provided once every other day with 9 ⁇ g each time and continued for 3 months.
  • the third course was administered from December Year 3 to March Year 4.
  • Intramuscular injection was performed every other day with 15 ⁇ g each time.
  • Response to rSIFN-co treatment CR ⁇ circle around (2) ⁇ (after surgery, no tumor recurrence or metastasis occurred at primary lesions.)
  • Survival After about 49 months (from May Year 1 to July Year 5), the patient remained alive.
  • FIGS. 29a-29b During 25 months after surgery, no recurrence or systemic metastasis occurred in the cured primary lesions.
  • Patient 17 Gender Female Age: 25 Cytologic diagnosis: Cervical smear on May 11, Year 1 showed high-grade intraepithelial lesion.
  • Clinical and pathological staging ⁇ circle around (1) ⁇ Ib1 Regimens before administration of none rSIFN-co: Regimens: administration of rSIFN-co Treatment of rSIFN-co began on May 14, Year 1. alone Intramuscular injection of rSIFN-co was provided once every other day: 9 ⁇ g for 1st time, 15 ⁇ g for 2nd time and 18 ⁇ g for 3rd time and thereafter. Meanwhile, uterine perfusion was done once a day: at 1000 ⁇ g per dose, for 2 hours.
  • Prostatic cancer/Intramuscular injection of rSIFN-co and local spraying to skin surface where prostate biopsy was done
  • rSIFN-co combined with local radiotherapy.
  • the prostate tumor and two lymph nodes in right-sided ischiorectal fossa were eliminated; the posterior wall of fundus of urinary bladder, bilateral seminal vesicles and anterior rectal wall infected by lesions recovered; and the level of tumor marker (PSA) become normal.
  • PSA tumor marker
  • Patient 18 Gender Male Age: 64 Pathological diagnosis: Adenocarcinoma was found in the 1st-10th prostate biopsy. Clinical and pathological staging ⁇ circle around (1) ⁇ : T 4 N 1 M 0. IV Regimens before administration of none rSIFN-co: Regimens: administration of rSIFN-co Treatment of rSIFN-co began on November 15, combined with radiotherapy Year 1. Intramuscular injection of rSIFN-co was provided once every other day: 9 ⁇ g for 1st time, 15 ⁇ g for 2nd time, 18 ⁇ g for 3rd time and 24 ⁇ g for 4th time and thereafter.
  • the amount of rSIFN-co to be intramuscularly injected changed to 21 ⁇ g from December 15, Year 1 to July 1, Year 2.
  • Radiotherapy on prostate (EBRT) ⁇ circle around (12) ⁇ was performed for 38 times from December 5, Year 1 to February 26, Year 2.
  • the prostate was smaller in size and left and irregular mass shadows of about posterior part protruded slightly. No obvious 4.7 ⁇ 4.3 ⁇ 5.6 cm in size were formed with abnormality was found in each imaging sequence obsecure border and inhomogeneous signal. signals. Inhomogeneous reinforcement 2.
  • Bladder wall was inhomogeneously thickened: happened in enhanced scan. All these inflammation? suggested the occurrence of prostatic 3.
  • Two lymph nodes in right-sided ischiorectal fossa were found with diameter of about 1 cm, suggesting the occurrence of metastasis. 3.
  • Patient 19 Gender Female Age: 43 Pathological diagnosis: Tumors were found in the neoplasma inside the right maxillary sinus. Malignant melanoma was proved by immunohistochemistry: (HMB45 (part+), MART1 ( ⁇ ), S100 ( ⁇ ), CD63 (+), NSE ( ⁇ ), PCK ( ⁇ ), EMA (+), CD56 ( ⁇ ) and KI671 25%). Clinical and pathological staging ⁇ circle around (1) ⁇ : pT 3 NxM 1 . IV Regimens before administration of rSIFN-co: Two cycles were provided on October 30, Year 1 and November 30, Year 1: 15 mg of Endostar on day 1 ⁇ 10 and 200 mg of temozolomide on day 1 ⁇ 5, oral administration.
  • Targeted radiotherapy (50Gy/25f) was done on November 2, Year 1 and the targets were right maxillary sinus + 1 ⁇ 4 of the left maxillary sinus, bilateral ethmoid sinus, frontal sinus and the adjacent tissues of the right eyeball. Radiotherapy ended on December 7, Year 1.
  • Regimens administration of rSIFN-co alone Treatment of rSIFN-co began on December 21, Year 1. Intramuscular injection of rSIFN-co was provided once every other day: 9 ⁇ g for 1st time, 15 ⁇ g for 2nd time, 18 ⁇ g for 3rd time and thereafter.
  • the drug was locally applied by spraying onto the skin surface of the right shouder: 70 ⁇ g-139 ⁇ g/ dose/site, 4-5 doses/day. Spraying was provided to skin surface of the left shoulder and other sites with bone metastasis began on February 27, Year 2: 70 ⁇ g-139 ⁇ g/dose/site, 4-5 doses/day.
  • Radiotherapy of lung cancer refer to Modern Lung Cancer Pathology and Clinical Practice /Edited by Xiong Min and Wu Yilong, (Beijing: Science Press, 2003 June), p 324-365;

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