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Last Updated: March 29, 2024

Claims for Patent: 7,745,396


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Summary for Patent: 7,745,396
Title:Use of SERP-1 as an antiplatelet agent
Abstract: Compositions and methods for antiplatelet/anti-thrombotic therapy in a mammalian subject are provided. The method involves administering a therapeutically effective amount of SERP-1 admixed with a pharmaceutically acceptable carrier to a subject in need of such therapy. Methods of administering SERP-1 with at least one other antiplatelet agent are also provided. The compositions and methods of the present invention are useful for treating and preventing recurrence of numerous cardiovascular diseases and injuries.
Inventor(s): Lucas; Alexandra (Gainesville, FL)
Assignee: Viron Therapeutics Inc. (London, CA)
Application Number:11/899,680
Patent Claims:1. A method of treating a cardiovascular disease-related thrombosis or embolism in a mammalian subject undergoing stent placement, said method comprising administering a therapeutically effective amount of serine proteinase inhibitor-1 (SERP-1), SERP-1 analog, or biologically active fragment thereof and a pharmaceutically acceptable carrier to said subject, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof inhibits thrombolytic proteases urokinase-type plasminogen activator, tissue-type plasminogen activator, and plasmin in vitro.

2. The method of claim 1, wherein said mammalian subject is human.

3. The method of claim 1, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof is delivered by oral administration, intravenous, intra-arterial, intra-articular, subcutaneous, intraperitoneal, intraspinal, intrarectal, or intramuscular infusion, or aerosol inhalant.

4. The method of claim 1, comprising administering a therapeutically effective amount of said SERP-1 or biologically active fragment thereof and a pharmaceutically acceptable carrier to said subject.

5. The method of claim 4, wherein said SERP-1 or biologically active fragment thereof is mature, processed SERP-1.

6. The method of claim 5, wherein said therapeutically effective amount of said mature, processed SERP-1 is about 5 .mu.g/kg to about 50 mg/kg per dose.

7. A method of treating a cardiovascular abnormal condition-related thrombosis or embolism in a mammalian subject undergoing stent placement, said method comprising administering a therapeutically effective amount of serine proteinase inhibitor-1 (SERP-1), SERP-1 analog, or biologically active fragment thereof and a pharmaceutically acceptable carrier to said subject, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof inhibits thrombolytic proteases urokinase-type plasminogen activator, tissue-type plasminogen activator, and plasmin in vitro.

8. The method of claim 7, wherein said mammalian subject is human.

9. The method of claim 7, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof is delivered by oral administration, intravenous, intra-arterial, intra-articular, subcutaneous, intraperitoneal, intraspinal, intrarectal, or intramuscular infusion, or aerosol inhalant.

10. The method of claim 7, comprising administering a therapeutically effective amount of said SERP-1 or biologically active fragment thereof and a pharmaceutically acceptable carrier to said subject.

11. The method of claim 10, wherein said SERP-1 or biologically active fragment thereof is mature, processed SERP-1.

12. The method of claim 11, wherein said therapeutically effective amount of said mature, processed SERP-1 is about 5 .mu.g/kg to about 50 mg/kg per dose.

13. A method of treating a cardiovascular disease-related thrombosis or embolism in a mammalian subject in need thereof, comprising administering a therapeutically effective amount of serine proteinase inhibitor-1 (SERP-1), SERP-1 analog, or biologically active fragment thereof and at least one other antiplatelet agent and a pharmaceutically acceptable carrier to said subject, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof inhibits thrombolytic proteases urokinase-type plasminogen activator, tissue-type plasminogen activator, and plasmin in vitro.

14. The method of claim 13, wherein said mammalian subject is human.

15. The method of claim 13, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof and said other antiplatelet agent are delivered by oral administration, intravenous, intra-arterial, intra-articular, subcutaneous, intraperitoneal, intraspinal, intrarectal, or intramuscular infusion, or aerosol inhalant.

16. The method of claim 13, comprising administering a therapeutically effective amount of said SERP-1 or biologically active fragment thereof and said other antiplatelet agent and said pharmaceutically acceptable carrier to said subject.

17. The method of claim 16, wherein said SERP-1 or biologically active fragment thereof is mature, processed SERP-1.

18. The method of claim 17, wherein said therapeutically effective amount of said mature, processed SERP-1 is about 5 .mu.g/kg to about 50 mg/kg per dose.

19. The method of claim 13, wherein said other antiplatelet agent comprises a compound selected from the group consisting of aspirin, clopidogrel, ridogrel, ticlopidine, and glycoprotein IIb/IIIa inhibitors.

20. The method of claim 19, wherein said other antiplatelet agent comprises a glycoprotein IIb/IIIa inhibitor selected from the group consisting of abciximab, integrilin, lamifiban, tirofiban, and xemlofiban.

21. The method of claim 13, wherein said other antiplatelet agent comprises Plavix.TM..

22. A method of treating a cardiovascular abnormal condition-related thrombosis or embolism in a mammalian subject in need thereof, comprising administering a therapeutically effective amount of serine proteinase inhibitor-1 (SERP-1), SERP-1 analog, or biologically active fragment thereof and at least one other antiplatelet agent and a pharmaceutically acceptable carrier to said subject, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof inhibits thrombolytic proteases urokinase-type plasminogen activator, tissue-type plasminogen activator, and plasmin in vitro.

23. The method of claim 22, wherein said mammalian subject is human.

24. The method of claim 22, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof and said other antiplatelet agent are delivered by oral administration, intravenous, intra-arterial, intra-articular, subcutaneous, intraperitoneal, intraspinal, intrarectal, or intramuscular infusion, or aerosol inhalant.

25. The method of claim 22, comprising administering a therapeutically effective amount of said SERP-1 or biologically active fragment thereof and said other antiplatelet agent and said pharmaceutically acceptable carrier to said subject.

26. The method of claim 25, wherein said SERP-1 or biologically active fragment thereof is mature, processed SERP-1.

27. The method of claim 26, wherein said therapeutically effective amount of said mature, processed SERP-1 is about 5 .mu.g/kg to about 50 mg/kg per dose.

28. The method of claim 22, wherein said other antiplatelet agent comprises a compound selected from the group consisting of aspirin, clopidogrel, ridogrel, ticlopidine, and glycoprotein IIb/IIIa inhibitors.

29. The method of claim 28, wherein said other antiplatelet agent comprises a glycoprotein IIb/IIIa inhibitor selected from the group consisting of abciximab, integrilin, lamifiban, tirofiban, and xemlofiban.

30. The method of claim 22, wherein said other antiplatelet agent comprises Plavix.TM..

31. A method of reducing the occurrence of a cardiovascular disease-related thrombosis or embolism in a mammalian subject undergoing stent placement, said method comprising administering a therapeutically effective amount of serine proteinase inhibitor-1 (SERP-1), SERP-1 analog, or biologically active fragment thereof and a pharmaceutically acceptable carrier to said subject, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof inhibits thrombolytic proteases urokinase-type plasminogen activator, tissue-type plasminogen activator, and plasmin in vitro.

32. The method of claim 31, wherein said mammalian subject is human.

33. The method of claim 31, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof is delivered by oral administration, intravenous, intra-arterial, intra-articular, subcutaneous, intraperitoneal, intraspinal, intrarectal, or intramuscular infusion, or aerosol inhalant.

34. The method of claim 31, comprising administering a therapeutically effective amount of said SERP-1 or biologically active fragment thereof and a pharmaceutically acceptable carrier to said subject.

35. The method of claim 34, wherein said SERP-1 or biologically active fragment thereof is mature, processed SERP-1.

36. The method of claim 35, wherein said therapeutically effective amount of said mature, processed SERP-1 is about 5 .mu.g/kg to about 50 mg/kg per dose.

37. A method of reducing the occurrence of a cardiovascular abnormal condition-related thrombosis or embolism in a mammalian subject undergoing stent placement, said method comprising administering a therapeutically effective amount of serine proteinase inhibitor-1 (SERP-1), SERP-1 analog, or biologically active fragment thereof and a pharmaceutically acceptable carrier to said subject, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof inhibits thrombolytic proteases urokinase-type plasminogen activator, tissue-type plasminogen activator, and plasmin in vitro.

38. The method of claim 37, wherein said mammalian subject is human.

39. The method of claim 37, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof is delivered by oral administration, intravenous, intra-arterial, intra-articular, subcutaneous, intraperitoneal, intraspinal, intrarectal, or intramuscular infusion, or aerosol inhalant.

40. The method of claim 37, comprising administering a therapeutically effective amount of said SERP-1 or biologically active fragment thereof and a pharmaceutically acceptable carrier to said subject.

41. The method of claim 40, wherein said SERP-1 or biologically active fragment thereof is mature, processed SERP-1.

42. The method of claim 41, wherein said therapeutically effective amount of said mature, processed SERP-1 is about 5 .mu.g/kg to about 50 mg/kg per dose.

43. A method of reducing the occurrence of a cardiovascular disease-related thrombosis or embolism in a mammalian subject in need thereof, comprising administering a therapeutically effective amount of serine proteinase inhibitor-1 (SERP-1), SERP-1 analog, or biologically active fragment thereof and at least one other antiplatelet agent and a pharmaceutically acceptable carrier to said subject, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof inhibits thrombolytic proteases urokinase-type plasminogen activator, tissue-type plasminogen activator, and plasmin in vitro.

44. The method of claim 43, wherein said mammalian subject is human.

45. The method of claim 43, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof and said other antiplatelet agent are delivered by oral administration, intravenous, intra-arterial, intra-articular, subcutaneous, intraperitoneal, intraspinal, intrarectal, or intramuscular infusion, or aerosol inhalant.

46. The method of claim 43, comprising administering a therapeutically effective amount of said SERP-1 or biologically active fragment thereof and said other antiplatelet agent and said pharmaceutically acceptable carrier to said subject.

47. The method of claim 46, wherein said SERP-1 or biologically active fragment thereof is mature, processed SERP-1.

48. The method of claim 47, wherein said therapeutically effective amount of said mature, processed SERP-1 is about 5 .mu.g/kg to about 50 mg/kg per dose.

49. The method of claim 43, wherein said other antiplatelet agent comprises a compound selected from the group consisting of aspirin, clopidogrel, ridogrel, ticlopidine, and glycoprotein IIb/IIIa inhibitors.

50. The method of claim 49, wherein said other antiplatelet agent comprises a glycoprotein IIb/IIIa inhibitor selected from the group consisting of abciximab, integrilin, lamifiban, tirofiban, and xemlofiban.

51. The method of claim 43, wherein said other antiplatelet agent comprises Plavix.TM..

52. A method of reducing the occurrence of a cardiovascular abnormal condition-related thrombosis or embolism in a mammalian subject in need thereof, comprising administering a therapeutically effective amount of serine proteinase inhibitor-1 (SERP-1), SERP-1 analog, or biologically active fragment thereof and at least one other antiplatelet agent and a pharmaceutically acceptable carrier to said subject, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof inhibits thrombolytic proteases urokinase-type plasminogen activator, tissue-type plasminogen activator, and plasmin in vitro.

53. The method of claim 52, wherein said mammalian subject is human.

54. The method of claim 52, wherein said SERP-1, SERP-1 analog, or biologically active fragment thereof and said other antiplatelet agent are delivered by oral administration, intravenous, intra-arterial, intra-articular, subcutaneous, intraperitoneal, intraspinal, intrarectal, or intramuscular infusion, or aerosol inhalant.

55. The method of claim 52, comprising administering a therapeutically effective amount of said SERP-1 or biologically active fragment thereof and said other antiplatelet agent and said pharmaceutically acceptable carrier to said subject.

56. The method of claim 55, wherein said SERP-1 or biologically active fragment thereof is mature, processed SERP-1.

57. The method of claim 56, wherein said therapeutically effective amount of said mature, processed SERP-1 is about 5 .mu.g/kg to about 50 mg/kg per dose.

58. The method of claim 52, wherein said other antiplatelet agent comprises a compound selected from the group consisting of aspirin, clopidogrel, ridogrel, ticlopidine, and glycoprotein IIb/IIIa inhibitors.

59. The method of claim 58, wherein said other antiplatelet agent comprises a glycoprotein IIb/IIIa inhibitor selected from the group consisting of abciximab, integrilin, lamifiban, tirofiban, and xemlofiban.

60. The method of claim 52, wherein said other antiplatelet agent comprises Plavix.TM..

61. The method of claim 5, wherein said mature, processed SERP-1 comprises the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

62. The method of claim 61, wherein said mature, processed SERP-1 consists of the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

63. The method of claim 11, wherein said mature, processed SERP-1 comprises the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

64. The method of claim 63, wherein said mature, processed SERP-1 consists of the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

65. The method of claim 17, wherein said mature, processed SERP-1 comprises the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

66. The method of claim 65, wherein said mature, processed SERP-1 consists of the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

67. The method of claim 26, wherein said mature, processed SERP-1 comprises the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

68. The method of claim 67, wherein said mature, processed SERP-1 consists of the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

69. The method of claim 35, wherein said mature, processed SERP-1 comprises the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

70. The method of claim 69, wherein said mature, processed SERP-1 consists of the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

71. The method of claim 41, wherein said mature, processed SERP-1 comprises the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

72. The method of claim 71, wherein said mature, processed SERP-1 consists of the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

73. The method of claim 47, wherein said mature, processed SERP-1 comprises the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

74. The method of claim 73, wherein said mature, processed SERP-1 consists of the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

75. The method of claim 56, wherein said mature, processed SERP-1 comprises the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

76. The method of claim 75, wherein said mature, processed SERP-1 consists of the mature, processed form of a polypeptide having the amino acid sequence of SEQ ID NO: 1.

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