Composition containing human alpha interferon species proteins and method for use thereof

• US 5,676,942 A
• Filed: 05/25/1995
• Issued: 10/14/1997
• Est. Priority Date: 02/10/1992
• Status: Expired due to Fees

• Current Assignee: Hemispherx Biopharma, Inc.
• Original Assignee: Interferon Sciences, Inc. (Stem Cell Innovations, Inc.)
• Inventors: DiPaola, Mario, Ferencz-Biro, Katalin, Testa, Douglas, Rashidbaigi, Abbas, Liao, Mei-June
• Primary Examiner(s): Sayala, Chhaya D.
• Application Number:
  US08/454,444
• Time in Patent Office: 873 Days
• Field of Search: 424/85.7, 424/85.4, 514/2, 514/21, 435/70.5, 530/351
• US Class Current: 424/85.7
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: C07K 14/56 IFN-alpha
• 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

This invention provides alpha interferon compositions comprising one or a mixture of selected highly antiviral interferon proteins, which compositions are characterized by increased anti-viral activity. These compositions may be used therapeutically in the treatment of viral infection, particularly retroviral or hepatitis infection or as additives to conventional antiviral agents to increase the antiviral potency thereof.

Claims

1. A pharmaceutical composition comprising a natural human leukocyte alpha interferon (IFN) species protein selected from the group consisting of IFN-α

4a, IFN-α

4b, IFN-α

7a, IFN-α

7c, IFN-α

8a, IFN-α

8b, IFN-α

8c, IFN-α

10a, IFN-α

16, IFN-α

17a, IFN-α

17b, IFN-α

17c, IFN-α

17d, IFN-α

21a, IFN-α

21b and combinations thereof, in a pharmaceutically acceptable carrier, said composition containing substantially no IFN-α

2a, IFN-α

2b or IFN-α

2c and characterized by an anti-viral activity greater than that of IFN-α

2a, IFN-α

2b, or IFN-α

2c.

2. The composition according to claim 1 consisting essentially of the alpha IFN species of peak 6 of Table 11, corresponding to at least one specie selected from the group consisting of IFN-α

8a, IFN-α

8b, IFN-α

8c and combinations thereof.

3. The composition according to claim 1 consisting essentially of IFN-α

8b.

4. The composition according to claim 1 consisting essentially of the alpha IFN species of peak 2 of Table 11, corresponding to at least one protein selected from the group consisting of IFN-α

4a, IFN-α

4b, IFN-α

16, and combinations thereof.

5. The composition according to claim 1 consisting essentially of the alpha IFN species of peak 5of Table 11, corresponding to at least one protein selected from the group consisting of IFN-α

7a, IFN-α

7b, IFN-α

7c, IFN-α

17a, IFN-α

17b, IFN-α

17c, IFN-α

17d, IFN-α

21a, IFN-α

21b, and combinations thereof.

6. The composition according to claim 1 consisting essentially of an effective amount of the alpha IFN species of peak 4 of Table 11, corresponding to a protein selected from the group consisting of IFN-α

8a, IFN-α

8b, IFN-α

8c, IFN-α

17a, IFNα

17b, IFN-α

17c, IFN-α

17d, IFN-α

21a, IFN-α

21b, and combinations thereof.

7. The composition according to claim 1 consisting essentially of IFN-α

10a.

9. A method of treating a retroviral infection i a mammalian host comprising administering to said host a pharmaceutically effective amount of a composition of claim 1.

10. The method according to claim 9 wherein the retrovirus is selected from the group consisting of HIV 1, HIV 2, HTLV I and HTLV II.

11. A method of treating a viral hepatitis infection in a mammalian host comprising administering to said host a pharmaceutically effective amount of the composition of claim 1.

12. The method according to claim 11 wherein said hepatitis infection is selected from the group consisting of Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis D, and Hepatitis E.

13. A method for enhancing the potency of an antiviral agent comprising adding to said antiviral agent an effective amount of the composition of claim 1.

14. A pharmaceutical composition comprising an effective amount of an antiviral additive composition comprising the composition of claim 1, in admixture with a selected second antiviral agent, said pharmaceutical composition characterized by an anti viral specific activity greater than that of the second antiviral agent alone.

15. The composition according to claim 14 wherein said effective amount is at least 1% by weight.

16. The composition according to claim 14 wherein said effective amount is at least 5% by weight.

17. The composition according to claim 14 wherein said antiviral additive composition consists essentially of the alpha IFN mixture of peak 6 of Table 11, corresponding to at least one specie selected from the group consisting of IFN-α

8a, IFN-α

8b, IFN-α

8c and combinations thereof.

18. The composition according to claim 14 wherein said antiviral additive composition consists essentially of IFN-α

8b.

19. The composition according to claim 14 wherein said antiviral additive composition consists essentially of the alpha IFN species of peak 2 of Table 11, corresponding to at least one protein selected from the group consisting of IFN-α

4a, IFN-α

4b, IFN-α

16, and combinations thereof.

20. The composition according to claim 14 wherein said antiviral additive composition consists essentially of the alpha IFN species of peak 5 of Table 11, corresponding to at least one protein selected from the group consisting of IFN-α

7a, IFN-α

7b, IFN-α

7c, IFN-α

17a, IFN-α

17b, IFN-α

17c, IFN-α

17d, IFNα

21a, IFN-α

21b, and combinations thereof.

21. The composition according to claim 14 wherein said antiviral additive composition consists essentially of the alpha IFN species of peak 4 of Table 11, corresponding to a protein selected from the group consisting of IFN-α

8a, IFN-α

8b, IFN-α

8c, IFN-α

17a, IFN-α

17b, IFN-α

17c, IFN-α

17d, IFN-α

21a, IFN-α

21b, and combinations thereof.

22. The composition according to claim 14 wherein said antiviral agent consists essentially of IFN-α

10a.

8. A pharmaceutical composition comprising a mixture of natural human leukocyte alpha interferon (IFN) species proteins in a pharmaceutically acceptable carrier, said mixture comprising at least two selected from the group consisting of:

(a) the IFN species corresponding to peak 2 of Table 11, selected from the group consisting of IFNα

4a, IFN-α

4b, and IFN-α

16;

(b) the IFN species corresponding to peak of Table 11, IFN-α

10a;

(c) the IFN species corresponding to peak 4 of Table 11, selected from the group consisting of IFN-α

8a, IFN-α

8b, IFN-α

8c, IFN-α

21a, IFN-α

21b, IFN-α

17a, IFN-α

17b, IFN-α

17c, and IFN-α

17d;

(d) the IFN species corresponding to peak 5 of Table 11, selected from the group consisting of IFN-α

7a, IFN-α

7b, IFN-α

7c, IFN-α

17a, IFN-α

17b, IFN-α

17c, IFN-α

17d, IFN-α

21a, and IFN-α

21b;

(e) the IFN species corresponding to peak 6 of Table 11, selected from the group consisting of IFN-α

8a, IFN-α

8b, and IFN-α

8c;

wherein said composition contains substantially no IFN-α

1, IFN-α

2a, IFN-α

2b, IFN-α

2c, IFN-α

5, IFN-α

6, IFN-α

10b, IFN-α

13, IFN-α

14, or IFN-α

22 and is characterized by an anti viral activity greater than that of IFN-α

2a, IFN-α

2b, or IFN-α

2c.