IL299028A - Methods and compositions for treating chemotherapy-induced diarrhea - Google Patents

Methods and compositions for treating chemotherapy-induced diarrhea

Info

Publication number
IL299028A
IL299028A IL299028A IL29902822A IL299028A IL 299028 A IL299028 A IL 299028A IL 299028 A IL299028 A IL 299028A IL 29902822 A IL29902822 A IL 29902822A IL 299028 A IL299028 A IL 299028A
Authority
IL
Israel
Prior art keywords
composition
crofelemer
cancer
subject
chemotherapy
Prior art date
Application number
IL299028A
Other languages
Hebrew (he)
Original Assignee
Napo Pharmaceuticals Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Napo Pharmaceuticals Inc filed Critical Napo Pharmaceuticals Inc
Publication of IL299028A publication Critical patent/IL299028A/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (33)

What is claimed is:
1. A composition comprising crofelemer for use in a method of treating chemotherapy-induced diarrhea (CID) in a human subject undergoing chemotherapy.
2. The composition for use of claim 1, wherein the crofelemer is administered in combination with other chemotherapy agents.
3. The composition for use of claim 1, wherein the crofelemer is administered at the same time as chemotherapy to reduce or delay the onset of CID.
4. The composition for use of claim 1, wherein the crofelemer is administered before chemotherapy to prevent, reduce or delay the onset of CID.
5. The composition for use of claim 1, wherein the crofelemer is administered after chemotherapy to reduce the onset of or treat CID.
6. The composition for use of any one of the previous claims, wherein the chemotherapy is selected from alkylating agents, anthracyclines, cytoskeletal disruptors (taxanes), epothilones, histone deacetylase inhibitors, inhibitors of topoisomerase I, inhibitors of topoisomerase II, kinase inhibitors, nucleotide analogs and precursor analogs, peptide antibiotics, platinum-based agents and retinoids.
7. The composition for use of claim 6, wherein the chemotherapy comprises one or more tyrosine kinase inhibitors.
8. The composition for use of claim 7, wherein the tyrosine kinase inhibitor is selected from lapatinib, sunitinib, sorafenib, erlotinib, gefitinib, axitinib, imatinib, nilotinib, dasatinib, cabozantinib, ruxolitinib, neratinib, bosutinib, pazopanib, afatninib, lenvatinib, tucatinib, vandetanib, ceritinib, crizotinib, dacomitinib, and valatinib.
9. The composition for use of claim 7, wherein the tyrosine kinase inhibitor (TKI) is an anaplastic lymphoma kinase (ALK) TKI.
10. The composition for use of claim 8, wherein the ALK TKI is selected from crizotinib, ceritinib and alectinib.
11. The composition for use of claim 6, wherein the chemotherapy is a phosphoinositide 3-kinase inhibitor.
12. The composition for use of claim 11, wherein the phosphoinositide 3-kinase inhibitor is alpelisib.
13. The composition for use of claim 6, wherein the chemotherapy is a CDK (cyclin-dependent kinase) 4/6 inhibitor.
14. The composition for use of claim 13, wherein the CDK 4/6 inhibitor is abemaciclib.
15. The composition for use of any one of claims 1 to 6, wherein the chemotherapy comprises one or more HER (Human epidermal growth factor receptor) inhibitors.
16. The composition for use of claim 15, wherein the HER inhibitor is selected from RG7116, RG1273 (pertuzumab), RG3502 (trastuzumab emantasine, T-DMI), RG5(trastuzumab), RGA201 (RG7160), erlotinib, dacomitinib (PF-00299804), PF-052800(Pfizer’s biosimilar mAB to RG597).
17. The composition for use of claim 1, wherein the crofelemer is administered after a subject begins to exhibit symptoms of CID.
18. The composition for use of claim 1, wherein the crofelemer is administered for the duration of treatment with the chemotherapy.
19. The composition for use of claim 1, wherein the crofelemer is administered until symptoms of CID are ameliorated and then crofelemer is discontinued.
20. The composition for use of claim 1, wherein the method comprises administering about 250 mg to about 1000 mg per day of crofelemer to a subject in need thereof.
21. The composition for use of claim 1, wherein the method comprises administering about 250 mg per day of crofelemer to a subject in need thereof.
22. The composition for use of claim 1, wherein the method comprises administering about 500 mg per day of crofelemer to a subject in need thereof.
23. The composition for use of claim 1, wherein the method comprises administering about 1000 mg per day of crofelemer to a subject in need thereof.
24. The composition for use of claim 1, wherein the method comprises administering about 125 mg two times per day of crofelemer to a subject in need thereof.
25. The composition for use of claim 1, wherein the method comprises administering about 250 mg two times per day of crofelemer to a subject in need thereof.
26. The composition for use of claim 1, wherein the method comprises administering about 500 mg two times per day of crofelemer to a subject in need thereof.
27. The composition for use of claim 1, wherein the crofelemer is administered as an enteric coated oral dosage form.
28. The composition for use of claim 1, wherein the crofelemer is administered as an oral dosage form that is not enteric coated.
29. The composition for use of claim 1, wherein the subject can tolerate a chemotherapeutic agent that the subject could not tolerate without the administration of crofelemer or can tolerate a higher dosage of chemotherapeutic than the subject could tolerate without administration of crofelemer.
30. The composition for use of claim 1, wherein a subject is considered treated if the subject demonstrates one or more of a decrease in the number of bowel movements per day, a decrease in the number of watery bowel movements per day, an improvement in the daily abdominal score for pain or discomfort, an improvement in the score for daily stool consistency, a decrease in stool consistency, a decrease in the number of days per week that subjects experienced urgency, a decrease in the number of days per week that subjects experienced fecal incontinence, or a decrease in the unscheduled visit for a significant worsening of diarrhea.
31. The composition for use of claim 1, wherein the administration results in a decrease in 1, 2 or 3 Grades of the Grade of diarrhea according to the Common Toxicity Criteria.
32. The composition for use of claim 1, wherein the subject is undergoing chemotherapy to treat a cancer selected from breast cancer, ovarian cancer, prostate cancer, bladder cancer, cervical cancer, uterine cancer, testicular cancer, kidney cancer, thyroid cancer, oral or oropharyngeal cancer, astrocytoma, sarcoma, mesothelioma, meningioma, lymphoma, myeloma, head and neck cancer, lung cancer, carcinoma (e.g., squamous cell carcinoma), malignant melanoma, peritoneal cancer, gastric cancer, hepatic cancer, colorectal cancer, gallbladder cancer, bone cancer, pancreatic cancer, tongue cancer, esophageal cancer, brain tumor, brain stem glioma, a metastases thereof, and leukemia.
33. A composition comprising crofelemer for use in a method of treating CID in a human subject undergoing chemotherapy for HER positive breast cancer, said method comprising administering the composition to said human subject at a dose of 125 mg crofelemer twice per day, wherein the chemotherapy is trastuzumab, pertuzumab, docetaxel, paclitaxel, or neratinib, or a combination thereof, with or without carboplatin.
IL299028A 2020-06-19 2020-06-19 Methods and compositions for treating chemotherapy-induced diarrhea IL299028A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2020/038691 WO2021257089A1 (en) 2020-06-19 2020-06-19 Methods and compositions for treating chemotherapy-induced diarrhea

Publications (1)

Publication Number Publication Date
IL299028A true IL299028A (en) 2023-02-01

Family

ID=79268234

Family Applications (1)

Application Number Title Priority Date Filing Date
IL299028A IL299028A (en) 2020-06-19 2020-06-19 Methods and compositions for treating chemotherapy-induced diarrhea

Country Status (10)

Country Link
EP (1) EP4168027A4 (en)
JP (1) JP2023538186A (en)
KR (1) KR20230027226A (en)
AU (1) AU2020454132A1 (en)
BR (1) BR112022025741A2 (en)
CA (1) CA3182864A1 (en)
IL (1) IL299028A (en)
JO (1) JOP20220339A1 (en)
MX (1) MX2022016367A (en)
WO (1) WO2021257089A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115089592B (en) * 2022-05-21 2024-02-27 复旦大学 Application of multiple tyrosine kinase in preparation of medicines for inhibiting enterovirus 71 type neurotropic viruses

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2485596A4 (en) * 2009-10-06 2013-07-17 Univ California Methods of treating diseases with proanthocyanidin oligomers such as crofelemer
MX348184B (en) * 2010-10-31 2017-06-02 Napo Pharmaceuticals Inc Methods and compositions for treating hiv-associated diarrhea.
US20160067311A1 (en) * 2014-09-10 2016-03-10 Helsinn Healthcare Sa Use of elsiglutide to treat gastrointestinal mucositis including chemotherapy-induced diarrhea
BR112017014750A2 (en) * 2015-01-09 2018-06-19 Jaguar Animal Health methods for treating diarrhea in pets
EP4295840A3 (en) * 2016-12-06 2024-03-13 DSM Nutritional Products, LLC Glycan polymers and related methods thereof

Also Published As

Publication number Publication date
WO2021257089A1 (en) 2021-12-23
MX2022016367A (en) 2023-01-30
JP2023538186A (en) 2023-09-07
BR112022025741A2 (en) 2023-01-03
CA3182864A1 (en) 2021-12-23
KR20230027226A (en) 2023-02-27
AU2020454132A1 (en) 2023-02-02
JOP20220339A1 (en) 2023-01-30
EP4168027A1 (en) 2023-04-26
EP4168027A4 (en) 2024-04-03

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