Methods and compositions for the treatment of diseases with consensus interferon while reducing side effect

• US 5,372,808 A
• Filed: 04/15/1992
• Issued: 12/13/1994
• Est. Priority Date: 10/17/1990
• Status: Expired due to Term

• Current Assignee: Amgen Inc.
• Original Assignee: Amgen Inc.
• Inventors: Blatt, Lawrence M., Taylor, Milton W.
• Primary Examiner(s): Hill, Jr., Robert J.
• Assistant Examiner(s): GUEST CERMAK, SHELLY
• Application Number:
  US07/868,916
• Time in Patent Office: 972 Days
• Field of Search: 530/351, 424/85.7, 424/85.6, 424/85.5, 424/85.4
• US Class Current: 424/85.4
• 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 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/1816 Erythropoietin [EPO]
• CPC Class Codes: A61K 38/193 Colony stimulating factors [CSF]
• CPC Class Codes: A61K 38/20 Interleukins [IL]
• CPC Class Codes: A61K 38/2006 IL-1
• CPC Class Codes: A61K 38/21 Interferons [IFN]
• CPC Class Codes: A61K 38/212 IFN-alpha
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• 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

Methods for the treatment of cell proliferation disorders, viral infections, and other conditions without causing significant side effects normally associated with interferon therapy, involving administering to a patient in need thereof a therapeutically effective amount of consensus human leukocyte interferon are disclosed. Also disclosed are pharmaceutical compositions of consensus human leukocyte interferon.

Claims

1. A method for treating a patient having a viral disease selected from the group consisting of hepatitis A, hepatitis B, hepatitis C or hepatitis Delta while reducing the occurrence of Grade 3or 4 toxicities associated with alpha interferon treatment as measured by the World Health Organization toxicity scale, which comprises administering to said patient a therapeutically effective amount of a consensus human leukocyte interferon.

2. A method according to claim 1, wherein said viral disease is hepatitis A.

3. A method according to claim 1, wherein said viral disease is hepatitis B.

4. A method according to claim 1, wherein said viral disease is hepatitis C.

5. A method according to claim 1, wherein said viral disease is hepatitis Delta.

7. A method according to claim 1 or 6, wherein said toxicities are selected from the group consisting of headache, fever, chills, nausea, anorexia. depression, and insomnia.

8. A method according to claim 1 or 6, wherein the consensus human leukocyte interferon is :

;

elected from the group consisting of IFN-con₁, IFN-con₂, and IFN-con₃.

9. A method according to claim 1 or 6, wherein the consensus human leukocyte interretort is ZFN-con₁.

10. A method according to claim 1 or 6, wherein the consensus human leukocyte interferon is a product of procaryotic expression of an exogenous DNA sequence.

11. A method according to claim 1 or 6, wherein the therapeutically effective amount is administered by a route of administration selected from the group consisting of oral, intravenous, intramuscular. subcutaneous, intranasal, and intralesional.

12. A method according;

to claim 1 or 6, wherein the therapeutically effective amount of consensus human leukocyte interferon is from 2×

10⁶ to 30×

10⁶ units per patient.

13. A method according to claim 1 or 6, wherein the therapeutically effective amount of consensus human leukocyte interferon is from 6×

10⁶ to 15×

10⁶ units per patient.

14. A method according to claim 1 or 6, wherein the patient is a human.

15. A method according to claim 1 or 6, further comprising administering a therapeutically effective amount of a chemotherapeutic agent.

16. A method according to claim 1 or 6, further comprising administering:

a therapeutically effective amount of G-CSF.

6. A method for treating a patient having Kaposi'"'"'s Sarcoma while reducing the occurrence of Grade 3 or 4 toxicities associated with alpha interferon treatment as measured by the World Health Organization toxicity scale, which comprises administering to said patient a therapeutically effective amount of a consensus human leukocyte interferon.