THERAPEUTIC PROTOCOLS

• US 20090306012A1
• Filed: 06/11/2009
• Published: 12/10/2009
• Est. Priority Date: 08/27/2001
• Status: Abandoned Application

• Current Assignee: Alchemia Oncology Pty Ltd. (The Sustainable Nutrition Group Ltd.)
• Original Assignee: Alchemia Oncology Pty Ltd. (The Sustainable Nutrition Group Ltd.)
• Inventors: BROWN, Tracey Jean, FOX, Richard Mark
• Application Number:
  US12/482,870
• Publication Number:
  US 20090306012A1
• Time in Patent Office: Days
• US Class Current: 514/54
• 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 31/728 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 9/0019 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

Abstract

The present invention relates to the field of chemotherapy of diseases such as cell proliferation disorders including cancer. In particular, the present invention relates to the use of hyaluronan (HA) as a protective agent in the treatment of subjects. HA is administered in conjunction with a chemotherapeutic agent to facilitate the prolonged administration of a dose of the chemotherapeutic agent to be administered to a subject. Owing to the protective effects of the HA, the dose of chemotherapeutic agent may be substantially higher than a generally accepted effective dose, which would otherwise be expected to cause unacceptable side effects in the subject.

Claims

1. A method which facilitates the prolonged administration of a dose of chemotherapeutic agent to a subject, wherein said dose is higher than a generally accepted effective dose, said method comprising the pre- and/or co-administration of an effective amount of HA.

2. The method of claim 1 wherein a single dose may be up to 200% higher and/or a cumulative dose may be up to 600% higher than generally accepted effective dose

3. The method of claim 2 wherein the dose of chemotherapeutic agent is from about 10% to about 150% higher than the generally accepted effective dose.

4. The method of claim 3 wherein the dose of chemotherapeutic agent is from about 35% to about 100% higher than the generally accepted effective dose.

5. The method of claim 1, wherein HA and the chemotherapeutic agent are simultaneously administered.

6. The method of claim 1, wherein HA is administered from about 24 hours to about 5 minutes before the chemotherapeutic agent.

7. The method of claim 1, wherein HA is administered from about 12 hours to about 10 minutes before the chemotherapeutic agent.

8. The method of claim 1, wherein HA is administered about half an hour before the chemotherapeutic agent.

9. The method of claim 1, wherein the effective amount of HA is from about 0.5 mg to about 20 mg per kilogram body weight per day.

10. The method of claim 1, wherein the effective amount of HA is from about 5 mg to about 10 mg per kilogram body weight per day.

11. A method for the prolonged treatment of a subject with a dose of a chemotherapeutic wherein a single dose may be up to 200% higher and/or the cumulative dose may be up to 600% higher than a generally accepted effective dose, said method comprising pre- and/or co-administering an effective amount of HA with said chemotherapeutic agent.

12. The method of claim 11 wherein the dose of chemotherapeutic agent is from about 10% to about 150% higher than the generally accepted effective dose.

13. The method of claim 12 wherein the dose of chemotherapeutic agent is from about 35% to about 100% higher than the generally accepted effective dose.

14. The method of claim 11 wherein HA and the chemotherapeutic agent are simultaneously administered.

15. The method of claim 11 wherein HA is administered from about 24 hours to about 5 minutes before the chemotherapeutic agent.

16. The method of claim 11 wherein HA is administered from about 12 hours to about 10 minutes before the chemotherapeutic agent.

17. The method of claim 11 wherein HA is administered about half an hour before the chemotherapeutic agent.

18. The method of claim 11 wherein the effective amount of HA is from about 0.5 mg to about 20 mg per kilogram body weight per day.

19. The method of claim 11 wherein the effective amount of HA is from about 5 mg to about 10 mg per kilogram body weight per day.