Hyaluronan as a drug pre-sensitizer and chemo-sensitizer in the treatment of disease

• US 8,287,894 B2
• Filed: 07/27/2005
• Issued: 10/16/2012
• Est. Priority Date: 07/14/2000
• Status: Expired due to Fees

• Current Assignee: Alchemia Oncology Limited
• Original Assignee: Alchemia Oncology Pty Ltd. (The Sustainable Nutrition Group Ltd.)
• Inventors: Brown, Tracey J., Fox, Richard M.
• Primary Examiner(s): Blanchard, David J
• Assistant Examiner(s): PURDY, KYLE A
• Application Number:
  US11/191,407
• Publication Number:
  US 20050267069A1
• Time in Patent Office: 2,638 Days
• Field of Search: None
• US Class Current: 424/422
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/4745 condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48
• CPC Class Codes: A61K 31/525 Isoalloxazines, e.g. riboflavins, vitamin B2
• CPC Class Codes: A61K 31/704 attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin digitoxin A61K31/7048
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/04 specific for metastasis

Abstract

This application provides methods and compositions for the treatment of cancer. The application provides compositions comprising hyaluronic acid and a chemotherapeutic agent such as irinotecan that are useful in the treatment of cancer.

Claims

1. A method of treating cancer comprising intravenously administering to a subject in need thereof a therapeutically effective amount of hyaluronan prior to the administration of at least one cancer chemotherapeutic agent, wherein the hyaluronan is intravenously administered from 24 hours to 30 minutes prior to the intravenous administration of the cancer chemotherapeutic agent and wherein the hyaluronan has a size expressed as a molecular weight of 750,000 to 1,500,000 Daltons.

2. The method according to claim 1 wherein the hyaluronan has an intrinsic viscosity of 10.0 dl/gm to 14.5 dl/gm.

3. The method according to claim 2 wherein the modal molecular weight of hyaluronan is 750,000 Daltons.

4. The method according to claim 2 wherein the modal molecular weight of hyaluronan is 1,500,000 Daltons.

5. The method according to claim 1 wherein the cancer is selected from the group consisting of breast, lung, prostate, kidney, neural, ovary, uterus, liver, pancreas, epithelial, gastric, intestinal, exocrine, endocrine, lymphatic, haematopoetic system or head and neck tissue.

6. The method according to claim 1 wherein the subject is a mammal.

7. The method according to claim 6 wherein the mammal is selected from the group consisting of bovine, canine, equine, feline, porcine and human.

8. The method according to claim 1 in which the cancer chemotherapeutic agent is selected from the group consisting of carmustine (BCNU), cisplatin (Platinol), Cytarabine, doxorubicin (Adriamycin), 5-fluorouracil (5FU), methotrexate (mexate), irinotecan (CPT-11), etoposide, plicamycin (Mithracin) and taxanes.

9. The method according to claim 8 wherein the cancer chemotherapeutic agent is 5-fluorouracil.

10. The method according to claim 8 wherein the cancer chemotherapeutic agent is irinotecan.

11. The method according to claim 8 wherein the cancer chemotherapeutic agent is doxorubicin.

12. The method according to claim 1 wherein the hyaluronan is administered from 24 hours to 1 hour before the administration of the cancer chemotherapeutic agent.

13. The method of claim 1 wherein the hyaluronan is administered from 12 hours to 30 minutes before the cancer chemotherapeutic agent.

14. The method of claim 1 wherein the amount of hyaluronan in the composition is from 0.5 mg to 150 mg per kilogram body weight per day.

15. The method of claim 1 wherein the amount of hyaluronan in the composition is from 5 mg to 40 mg per kilogram body weight per day.

16. The method of claim 1, wherein the wherein the modal molecular weight of hyaluronan is about 850,000 Daltons.