AU2010204547B2 - New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein - Google Patents

New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein Download PDF

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Publication number
AU2010204547B2
AU2010204547B2 AU2010204547A AU2010204547A AU2010204547B2 AU 2010204547 B2 AU2010204547 B2 AU 2010204547B2 AU 2010204547 A AU2010204547 A AU 2010204547A AU 2010204547 A AU2010204547 A AU 2010204547A AU 2010204547 B2 AU2010204547 B2 AU 2010204547B2
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AU
Australia
Prior art keywords
neug
csf
albumin
protein
dose
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
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AU2010204547A
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English (en)
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AU2010204547A1 (en
Inventor
Jason Benjamin Bock
Xia Luo
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Teva Pharmaceutical Industries Ltd
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Teva Pharmaceutical Industries Ltd
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Publication of AU2010204547A1 publication Critical patent/AU2010204547A1/en
Application granted granted Critical
Publication of AU2010204547B2 publication Critical patent/AU2010204547B2/en
Priority to AU2014202190A priority Critical patent/AU2014202190B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • A61K38/385Serum albumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/193Colony stimulating factors [CSF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/643Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2010204547A 2009-01-16 2010-01-15 New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein Ceased AU2010204547B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2014202190A AU2014202190B2 (en) 2009-01-16 2014-04-22 New Stable Formulations of Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor Fusion Protein

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US14544009P 2009-01-16 2009-01-16
US14543609P 2009-01-16 2009-01-16
US61/145,440 2009-01-16
US61/145,436 2009-01-16
PCT/US2010/021235 WO2010083434A2 (en) 2009-01-16 2010-01-15 New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2014202190A Division AU2014202190B2 (en) 2009-01-16 2014-04-22 New Stable Formulations of Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor Fusion Protein

Publications (2)

Publication Number Publication Date
AU2010204547A1 AU2010204547A1 (en) 2011-07-28
AU2010204547B2 true AU2010204547B2 (en) 2014-01-23

Family

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Family Applications (2)

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AU2010204547A Ceased AU2010204547B2 (en) 2009-01-16 2010-01-15 New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein
AU2010204552A Ceased AU2010204552B2 (en) 2009-01-16 2010-01-15 New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2010204552A Ceased AU2010204552B2 (en) 2009-01-16 2010-01-15 New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein

Country Status (16)

Country Link
US (4) US8323634B2 (enExample)
EP (2) EP2387419A2 (enExample)
JP (2) JP2012515222A (enExample)
KR (2) KR20110132326A (enExample)
CN (2) CN102378635A (enExample)
AU (2) AU2010204547B2 (enExample)
BR (2) BRPI1005159A2 (enExample)
CA (2) CA2749786A1 (enExample)
EA (2) EA201190079A1 (enExample)
IL (2) IL214051A0 (enExample)
MX (2) MX2011007583A (enExample)
NZ (2) NZ594055A (enExample)
SG (3) SG196821A1 (enExample)
UA (2) UA103221C2 (enExample)
WO (2) WO2010083439A2 (enExample)
ZA (1) ZA201105171B (enExample)

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US9061097B2 (en) * 2010-06-07 2015-06-23 Amgen Inc. Drug delivery device
CN102628869B (zh) * 2012-04-19 2014-04-02 上海蓝怡科技有限公司 提高甲胎蛋白抗体冻干稳定性的制剂
MX2015009141A (es) * 2013-01-15 2016-03-16 Teva Pharma Formulaciones de albu-bche, preparacion y usos de las mismas.
US20140271538A1 (en) 2013-03-15 2014-09-18 Teva Pharmaceutical Industries Ltd. Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor for the Prevention of Neutropenia in Pediatric Patients
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US10238650B2 (en) 2015-03-06 2019-03-26 Beyondspring Pharmaceuticals, Inc. Method of treating cancer associated with a RAS mutation
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EP3328415B1 (en) * 2015-07-30 2020-11-25 Endor Technologies, S.L. Colony stimulating factor for use in pancreatic or colon cancer treatment
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US11278665B2 (en) 2016-11-22 2022-03-22 Eitan Medical Ltd. Method for delivering a therapeutic substance
CN110431135A (zh) 2017-01-06 2019-11-08 大连万春布林医药有限公司 微管蛋白结合化合物及其治疗用途
KR20190109479A (ko) 2017-02-01 2019-09-25 비욘드스프링 파마수티컬스, 인코포레이티드. 호중구감소증의 감소 방법
WO2018187786A1 (en) * 2017-04-07 2018-10-11 La Jolla Institute For Allergy And Immunology Unipotent neutrophil progenitor cells, methods of preparation, and uses thereof
CN109420159A (zh) * 2017-08-23 2019-03-05 江苏泰康生物医药有限公司 一种重组蛋白药物的新型稳定制剂
WO2019147615A1 (en) 2018-01-24 2019-08-01 Beyondspring Pharmaceuticals, Inc. Composition and method for reducing thrombocytopenia via the administration of plinabulin
KR20200116477A (ko) * 2018-02-01 2020-10-12 비욘드스프링 파마수티컬스, 인코포레이티드. 플리나불린 및 g-csf 제제의 투여를 통해 화학요법-유도된 호중구감소증을 감소시키기 위한 조성물 및 방법
US11583633B2 (en) 2018-04-03 2023-02-21 Amgen Inc. Systems and methods for delayed drug delivery
US11357909B2 (en) 2018-10-05 2022-06-14 Eitan Medical Ltd. Triggering sequence
CN111383745A (zh) * 2018-12-29 2020-07-07 医渡云(北京)技术有限公司 计算机数据处理方法、装置、存储介质及设备
US11267858B2 (en) 2019-05-31 2022-03-08 Spectrum Pharmaceuticals, Inc. Methods of treatment using G-CSF protein complex
US11684655B2 (en) * 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex
CN112316120A (zh) * 2019-08-05 2021-02-05 天津派格生物技术有限公司 使用低动员型g-csf有效且安全治疗粒细胞减少症的方法
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Also Published As

Publication number Publication date
CA2749786A1 (en) 2010-07-22
WO2010083434A3 (en) 2010-09-10
WO2010083439A2 (en) 2010-07-22
CA2749802A1 (en) 2010-07-22
EA201190080A1 (ru) 2014-03-31
US8993519B2 (en) 2015-03-31
AU2010204552B2 (en) 2014-05-01
US20130129669A1 (en) 2013-05-23
NZ594056A (en) 2013-03-28
US20150202268A1 (en) 2015-07-23
NZ594055A (en) 2013-03-28
MX2011007583A (es) 2011-12-14
MX2011007582A (es) 2011-12-14
KR20110132326A (ko) 2011-12-07
EA201190079A1 (ru) 2013-02-28
EA023344B1 (ru) 2016-05-31
US20100297062A1 (en) 2010-11-25
AU2010204552A1 (en) 2011-08-04
IL214051A0 (en) 2011-08-31
WO2010083439A3 (en) 2010-09-10
US8323634B2 (en) 2012-12-04
BRPI1005159A2 (pt) 2018-04-03
KR20110132327A (ko) 2011-12-07
UA103221C2 (uk) 2013-09-25
IL214052A0 (en) 2011-08-31
US20100227818A1 (en) 2010-09-09
EP2387420A2 (en) 2011-11-23
CN102395379B (zh) 2015-07-22
CN102395379A (zh) 2012-03-28
CA2749802C (en) 2016-08-23
SG172940A1 (en) 2011-08-29
ZA201105171B (en) 2015-12-23
SG196821A1 (en) 2014-02-13
SG172941A1 (en) 2011-08-29
WO2010083434A2 (en) 2010-07-22
JP5753095B2 (ja) 2015-07-22
UA105201C2 (uk) 2014-04-25
AU2010204547A1 (en) 2011-07-28
BRPI1004940A2 (pt) 2018-06-19
JP2012515222A (ja) 2012-07-05
JP2012515221A (ja) 2012-07-05
CN102378635A (zh) 2012-03-14
EP2387419A2 (en) 2011-11-23

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