Combination treatments and compositions for wound healing comprising viral VEGF

• US 9,314,505 B2
• Filed: 05/17/2013
• Issued: 04/19/2016
• Est. Priority Date: 05/18/2012
• Status: Expired due to Fees

• Current Assignee: Otago Innovation Limited (University of Otago)
• Original Assignee: Otago Innovation Limited (University of Otago)
• Inventors: Fleming, Stephen Bruce, Mercer, Andrew Allan, Wise, Lyn Marie
• Primary Examiner(s): STOICA, ELLY GERALD
• Application Number:
  US13/897,280
• Publication Number:
  US 20130323201A1
• Time in Patent Office: 1,068 Days
• US Class Current: 1/1
• 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 38/1866 Vascular endothelial growth factor [VEGF]
• CPC Class Codes: A61K 38/2066 IL-10
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Viral VEGF and viral anti-inflammatory cytokine compositions, methods of treatment using them, and kits containing them for use in the promotion and/or improvement of wound healing and/or tissue repair, and for anti-scarring, anti-inflammatory, anti-fibrosis and anti-adhesion indications.

Claims

1. A method of treating a subject having a wound not healing at an expected rate, which comprises administration of an effective amount of a viral VEGF selected from the group consisting of a parapoxvirus VEGF E and an orf virus VEGF-E, and (ii) an anti-inflammatory cytokine, optionally a viral anti-inflammatory cytokine, optionally a viral anti-inflammatory interleukin, optionally viral IL-10, to a subject in need of treatment therewith, wherein said viral VEGF-E and said viral anti-inflammatory cytokine are administered in combination or administered separately.

2. A method according to claim 1, wherein said viral VEGF is a parapoxvirus virus VEGF-E.

3. A method according to claim 1, wherein said viral anti-inflammatory cytokine is selected from the group consisting of parapoxvirus IL-10 and orf virus IL-10.

4. A method according to claim 1, wherein the subject suffers from a wound selected from the group consisting of an acute wound, a delayed-healing wound, an incompletely healing wound, a chronic wound (optionally a diabetic ulcer, a venous ulcer, a pressure ulcer, a vasculitic ulcer, or an arterial ulcer), and a dehiscent wound, and wherein the composition optionally is applied prior to repair or closure of a wound.

26. A method according to claim 1, wherein the anti-inflammatory cytokine is a mammalian anti-inflammatory cytokine.

27. A method according to claim 26, wherein the mammalian anti-inflammatory cytokine is a mammalian anti-inflammatory interleukin.

28. A method according to claim 27, wherein the mammalian anti-inflammatory interleukin is IL-10.

5. A composition comprising a viral VEGF selected from the group consisting of a parapoxvirus VEGF-E and an orf virus VEGF-E and a viral anti-inflammatory cytokine effective to promote wound healing and a pharmaceutically acceptable carrier, wherein the composition optionally is formulated for administration via a route selected from the group consisting of topical administration and injection.

6. A composition according to claim 5 which is in the form of a cream, ointment, gel, emulsion, lotion, foam, or paint, wherein when the composition is a gel, the gel optionally comprises a nonionic polyoxyethylene-polyoxypropylene copolymer gel.

7. A composition according to claim 5, wherein said viral VEGF is a parapoxvirus virus VEGF-E.

8. A composition according to claim 5, wherein said viral anti-inflammatory cytokine is selected from the group consisting of a parapoxvirus IL-10 and an orf virus IL-10.

9. A method of manufacture of a medicament comprising bringing together amounts of a viral VEGF selected from the group consisting of a parapoxvirus VEGF-E and an orf virus VEGF-E and a viral anti-inflammatory cytokine effective to promote wound healing and a pharmaceutically acceptable carrier.

10. A method according to claim 9, wherein said viral VEGF is VEGF-E, wherein the VEGF-E optionally is a parapoxvirus virus VEGF-E.

11. A method according to claim 9, wherein said viral anti-inflammatory cytokine is a viral anti-inflammatory interleukin, optionally viral IL-10, optionally parapoxvirus IL-10, optionally orf virus IL-10.

12. An article of manufacture comprising package material containing therapeutically effective amounts of a viral VEGF selected from the group consisting of a parapoxvirus VEGF-E and an orf virus VEGF-E and a viral anti-inflammatory cytokine together with instructions for use in the treatment of a wound in or on a subject.

13. An article of manufacture according to claim 12, wherein the viral VEGF and the viral anti-inflammatory cytokine are contained in a single vessel.

14. An article of manufacture according to claim 12, wherein the viral VEGF and the viral anti-inflammatory cytokine are contained in separate vessels.

15. An article of manufacture according to claim 12, wherein said viral VEGF is a parapoxvirus virus VEGF-E.

16. An article of manufacture according to claim 12, wherein said viral anti-inflammatory cytokine is a viral anti-inflammatory interleukin, optionally viral IL-10, optionally parapoxvirus IL-10, optionally orf virus IL-10.

17. An article of manufacture according to claim 12, wherein the subject suffers from a wound selected from the group consisting of an acute wound, a delayed-healing wound, an incompletely healing wound, a chronic wound (optionally a diabetic ulcer, a venous ulcer, a pressure ulcer, a vasculitic ulcer, or an arterial ulcer), and a dehiscent wound, and wherein the composition optionally is applied prior to repair or closure of a wound.

18. An article of manufacture according to claim 12, wherein the viral VEGF and the viral anti-inflammatory cytokine are (a) formulated for administration by injection or (b) formulated for topical administration.

19. An article comprising package material containing therapeutically effective amounts of each of (i) a viral VEGF selected from the group consisting of a parapoxvirus VEGF-E and an orf virus VEGF-E, and (ii) an anti-inflammatory cytokine, optionally a viral anti-inflammatory cytokine, optionally a viral anti-inflammatory interleukin, optionally viral IL-10, together with instructions for use in the treatment of a wound in or on a subject.

29. An article according to claim 19, wherein the anti-inflammatory cytokine is a mammalian anti-inflammatory cytokine.

30. An article according to claim 29, wherein the mammalian anti-inflammatory cytokine is a mammalian anti-inflammatory interleukin.

31. An article according to claim 30, wherein the mammalian anti-inflammatory interleukin is IL-10.

20. A composition comprising a viral VEGF selected from the group consisting of a parapoxvirus VEGF-E and an orf virus VEGF-E and a mammalian anti-inflammatory cytokine effective to promote wound healing and a pharmaceutically acceptable carrier, wherein the composition optionally is formulated for administration via a route selected from the group consisting of topical administration and injection.

21. A composition according to claim 20, wherein the mammalian anti-inflammatory cytokine is a mammalian anti-inflammatory interleukin.

22. A composition according to claim 21, wherein the mammalian anti-inflammatory interleukin is IL-10.

23. An article of manufacture comprising package material containing therapeutically effective amounts of a viral VEGF selected from the group consisting of a parapoxvirus VEGF-E and an orf virus VEGF-E and a mammalian anti-inflammatory cytokine together with instructions for use in the treatment of a wound in or on a subject.

24. An article of manufacture according to claim 23, wherein the mammalian anti-inflammatory cytokine is a mammalian anti-inflammatory interleukin.

25. An article of manufacture according to claim 24, wherein the mammalian anti-inflammatory interleukin is IL-10.