Combination therapy for treatment of fibrotic disorders

• US 20060110358A1
• Filed: 08/20/2003
• Published: 05/25/2006
• Est. Priority Date: 08/28/2002
• Status: Abandoned Application

• Current Assignee: Intermune Incorporated (Roche Holding AG)
• Original Assignee: Intermune Incorporated (Roche Holding AG)
• Inventors: Hsu, Henry H.
• Application Number:
  US10/526,087
• Publication Number:
  US 20060110358A1
• Time in Patent Office: Days
• US Class Current: 424/85.600
• 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 31/4412 having oxo groups directly attached to the heterocyclic ring
• CPC Class Codes: A61K 38/217 IFN-gamma
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 19/04 for non-specific disorders of the connective tissue
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

The present invention provides methods of treating a fibrotic disorder. The methods generally involve administering an effective amount of IFN-γ and an effective amount of pirfenidone or a pirfenidone analog.

Claims

1. A method of treating a fibrotic disease in an individual, the method comprising administering to an individual suffering from a fibrotic disease a synergistic combination of IFN-γ

and pirfenidone or a specific pirfenidone analog that is effective in the treatment or prophylaxis of the fibrotic disease in the individual.

4. The method of any of claims 1-3 wherein the fibrotic disease is pulmonary fibrosis.

5. The method of claim 4 wherein the pulmonary fibrosis is idiopathic pulmonary fibrosis.

6. The method of claim 4 wherein the pulmonary fibrosis is from a known etiology.

7. The method of any of claims 1-3 wherein the fibrotic disease is liver fibrosis.

8. The method of any of claims 1-3 wherein the fibrotic disease is renal fibrosis.

9. The method of any of claims 1-3 wherein the fibrotic disease is cardiac fibrosis.

10. The method of any of claims 1-3 wherein the fibrotic disease is scleroderma.

11. The method of any of claims 1-10 wherein the individual is a human.

2. A method of treating a fibrotic disease in an individual, the method comprising administering to an individual suffering from a fibrotic disease a combination of IFN-γ

and pirfenidone or a specific pirfenidone analog that is effective in the treatment or prophylaxis of the fibrotic disease in the individual and that reduces the incidence or severity of one or more side effects ordinarily associated with the administration of either drug alone in the treatment of the fibrotic disease.

3. A method of treating a fibrotic disease in an individual, the method comprising administering to an individual suffering from a fibrotic disease a combined dosage of about 50 mcg to about 200 mcg IFN-γ

three times weekly and about 400 mg to about 3600 mg pirfenidone or a specific pirfenidone analog daily.