Method for treating diseases with omega interferon

• US 20070248572A1
• Filed: 06/07/2007
• Published: 10/25/2007
• Est. Priority Date: 11/09/2001
• Status: Abandoned Application

• Current Assignee: Intarica Therapeutics Incorporated
• Original Assignee: Intarica Therapeutics Incorporated
• Inventors: Langecker, Peter, Blanchett, Dennis, Moran, S.
• Application Number:
  US11/811,415
• Publication Number:
  US 20070248572A1
• Time in Patent Office: Days
• US Class Current: 424/85.400
• CPC Class Codes: A61K 2039/505 comprising antibodies
• 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 31/4172 Imidazole-alkanecarboxylic acids, e.g. histidine
• CPC Class Codes: A61K 38/21 Interferons [IFN]
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A method of treating an immunologic, proliferative, or infectious disease in a warm-blooded animal is disclosed. The method comprises administering to the animal omega interferon (IFN) at a dosage and activity for the disease state treated sufficient to induce a therapeutic response in the animal, which dosage and activity for the disease state treated is higher than would be well-tolerated based on data for non-omega IFN'"'"'s. The omega IFN is administered alone or In combination with a therapeutically effective amount of at least one adjunctive therapeutic agent. Also disclosed is an article of manufacture useful for treating an immunologic, proliferative, or infectious disease, which article comprises (1) omega IFN in a form suitable for administering a therapeutically effective amount of the omega IFN to the subject in order to induce the desired therapeutic response (2) instructions for administering the omega IFN as desired, that is higher than would be well-tolerated based on data for non-omega IFNs.

Claims

1. A method of treating an immunologic, proliferative, or infectious disease in a warm-blooded animal, which method comprises administering to the animal omega interferon (IFN) at a dosage and activity for the disease state treated sufficient to induce a therapeutic response in the animal, which dosage and activity for the disease state treated is higher than would be well-tolerated based on data for non-omega IFNs.

5. The method of claim 1, wherein the disease is a viral disease and the animal is a human.

6. The method of claim 5, wherein the viral disease causes hepatitis.

7. The method of claim 6, wherein the hepatitis is hepatitis B, C, D, or G.

9. The method of claim 5, wherein the viral disease is yellow fever.

10. The method of claim 1, wherein the subject exhibits primary or secondary resistance to treatment with a non-omega IFN.

11. The method of claim 1, wherein omega IFN is administered with an adjunctive therapeutic agent.

12. The method of claim 11, wherein the adjunctive therapeutic agent is an inosine monophosphate dehydrogenase inhibitor, interleukin-2, an interleukin-2 derivative, histamine, a histamine derivative, a monoclonal antibody, small molecule inhibitor of hepatitis C viral replication, or a polyclonal antibody.

13. The method of claim 12, wherein the inosine monophosphate dehydrogenase inhibitor is ribavirin or a ribavirin analog.

15. The method of claim 12, wherein the inosine monophosphate dehydrogenase inhibitor is selected from the group consisting of mycophenolic acid, mycophenolate mofetil, mycophenolic acid sodium, aminothiadiazole, thiophenfurin, tiazofurin, viramidine, VX-148, VX-497, and VX-944.

16. The method of claim 15, wherein the inosine monophosphate dehydrogenase inhibitor is administered to a human subject at a therapeutically effective dose that may vary from about 200 to about 4800 mg per day.

17. The method of claim 1, wherein the dose of omega interferon is administered parenterally, enterally, or topically.

18. The method of claim 17, wherein the omega interferon is administered parenterally.

19. The method of claim 18, wherein the omega interferon is administered subcutaneously.

20. The method of claim 19, wherein the omega interferon is administered subcutaneously at a controlled rate over time.

21. The method of claim 17, wherein the dose of omega is administered using a device.

22. The method of claim 21, wherein the device is a pump.

25. The method of claim 19, wherein the omega interferon is administered subcutaneously three times weekly.

26. The method of claim 1, wherein the disease is a proliferative disease.

28. The method of claim 26, wherein the disease is mycosis fungoides, multiple sclerosis, chronic granulomatous disease, pulmonary fibrosis, hepatic fibrosis, fibrosis of any other organ or tissue, hepatic cirrhosis, or tuberculosis.

2-4. -4. (canceled)

8. (canceled)

14. (canceled)

23-24. -24. (canceled)

27. (canceled)

29-55. -55. (canceled)