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.
- 2. The method of claim 1, wherein the units of activity per microgram (μg) of omega IFN exceed the units of activity per μg of the non-omega IFN by a factor of more than 1 to about 3.
- 3. The method of claim 2, wherein the units of activity per μg of omega IFN exceed the units of activity per μg alpha IFN by a factor of two.
- 4. The method of claim 2, wherein the dose of omega IFN is about 135-700 μg/week and the omega IFN activity is about 27-420 million international units.
- 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.
- 8. The method of claim 1, wherein the disease is cirrhosis or hepatic fibrosis and the animal is a human.
- 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.
- 14. The method of claim 13, wherein the inosine monophosphate dehydrogenase inhibitor is ribavirin and is administered to a human subject at about 400 to about 1200 mg per day.
- 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.
- 23. The method of claim 21, wherein the device is a gel.
- 24. The method of claim 31, wherein the device is a non-gel polymer.
- 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.
- 27. The method of claim 26, wherein the disease is hairy cell leukemia, malignant melanoma, multiple myeloma, follicular lymphoma, non-Hodgkin's lymphoma, cutaneous T-Cell lymphoma, chronic myelogenous leukemia, basal cell carcinoma, carcinoid syndrome, superficial bladder cancer, renal cell cancer, colorectal cancer, laryngeal papillomatosis, actinic keratosis, or Kaposi's sarcoma, or other interferon-sensitive cancer.
- 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.
- 29. The method of claim 1, wherein the subject exhibits primary resistance to the administration of alfa IFN, beta IFN, consensus IFN, gamma IFN, leukocyte-derived IFN, or tau IFN, with or without the use of an adjunctive therapeutic agent.
- 30. The method of claim 1, wherein the subject is a hepatitis C-infected human that exhibits secondary resistance to alfa IFN, beta IFN, consensus IFN, gamma IFN, leukocyte-derived IFN, or tau IFN.
- 31. The method of claim 1, wherein the omega interferon is administered to such animal, optionally in combination with a therapeutically effective amount of at least one an adjunctive therapeutic agent, for as long a period of time as the animal tolerates omega interferon, monitoring the levels of a disease marker in the animal during the administration, and continuing the administration omega interferon for so long as the levels of the disease marker continue to be reduced.
- 32. The method of claim 31, wherein the disease is hepatitis B, C, or D and the animal is a human.
- 33. The method of claim 31, wherein the disease is a viral disease does not cause hepatitis and the animal is a human.
- 34. The method of claim 31, wherein the disease is yellow fever.
- 35. The method of claim 31, wherein omega interferon is administered with an adjunctive therapeutic agent.
- 36. The method of claim 31, wherein the disease is a proliferative disease.
- 37. The method of claim 36, wherein the disease is selected from the group consisting of hairy cell leukemia, malignant melanoma, multiple myeloma, follicular lymphoma, non-Hodgkin's lymphoma, cutaneous T-Cell lymphoma, chronic myelogenous leukemia, basal cell carcinoma, carcinoid syndrome, superficial bladder cancer, renal cell cancer, colorectal cancer, laryngeal papillomatosis, actinic keratosis, Kaposi's sarcoma.
- 38. The method of claim 36, wherein the disease mycosis fungoides, multiple sclerosis, chronic granulomatous disease, pulmonary fibrosis, hepatic fibrosis, fibrosis of any other organ or tissue, hepatic cirrhosis, or tuberculosis.
- 39. The method of claim 31, wherein the disease is an immunological disease.
- 40. An article of manufacture useful for treating an immunologic, proliferative, or infectious disease in a warm-blooded animal subject, which article comprises omega interferon (IFN) suitable for administering a therapeutically effective amount of the omega IFN to the subject in combination with instructions for administering the omega IFN at a dosage and activity for the disease state treated that is higher than would be well-tolerated based on data for non-omega IFNs.
- 41. The article of claim 40, wherein the article is suitable for enteral, parenteral or topical administration.
- 42. The article of claim 41, wherein the article is suitable for injection into the subject.
- 43. The article of claim 42, wherein the article is suitable for subcutaneous injection of omega IFN.
- 44. The article of claim 43, wherein the omega IFN is suitable for subcutaneous injection for controlled release of the omega IFN into the subject at a rate of about 135-700 μg per week.
- 45. The article of claim 44, wherein the controlled rate of release extends for at least one month.
- 46. The article of claim 42, wherein the omega IFN is formulated as a sterile aqueous composition for injection.
- 47. A process for preparing an omega interferon (IFN)-based article of manufacture useful for treating an immunologic, proliferative, or infectious disease in a warm-blooded animal subject, which process comprises
providing omega IFN as a composition suitable for administering to the subject at a therapeutically effective dosage, and combining the omega IFN so provided with instructions for administering the omega IFN for such disease at a dosage and activity for the disease state being treated that is higher than would be well-tolerated based on data non-omega IFNs.
- 48. The process of claim 47, wherein the omega IFN is suitable for enteral, parenteral, or topical administration.
- 49. The process of claim 48, wherein the omega IFN is suitable for parenteral administration into the subject.
- 50. The process of claim 49, wherein the omega IFN is suitable for subcutaneous administration.
- 51. The process of claim 50, wherein the omega IFN is suitable for subcutaneous administration for controlled release of the omega IFN into the subject at a rate of about 135-700 μg per week.
- 52. The process of claim 51, wherein the controlled rate of release extends for at least one month.
- 53. The process of claim 51, wherein the omega IFN is formulated as a sterile aqueous composition for injection or implantation.
- 54. The process of claim 51, wherein the omega IFN is suitable for injection into the subject.
- 55. The use omega interferon (IFN) in the manufacture of a medicament for treating an immunologic, proliferative, or infectious disease in a warm-blooded animal, wherein the medicament is for administration to the animal at a dosage and activity for the disease 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.
CROSS-REFERENCE
[0001] This application claims priority to U.S. Provisional Application No. 60/337,948 filed Nov. 9, 2001, and incorporates the entirety of that application by reference herein. This application converts the provisional application to a regular utility application.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60337948 |
Nov 2001 |
US |