IP Library Granted Patent US 7,309,606
Granted Patent B2
US 7,309,606 · App. 11/220,485 · Granted Dec 18, 2007

Methods and compositions for treating hypercholesterolemia

Assignees: The Trustees of Boston University; KOS Pharmaceuticals, Inc.
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Quick Facts
Patent No.
US 7,309,606
App. No.
11/220,485
Granted
Dec 18, 2007
Kind
B2
Abstract

The present invention provides methods and compositions for treating hypercholesterolemia using therapeutic apoE proteins. A therapeutic apoE protein is a naturally-occurring apoE protein (e.g., apoE1, apoE2, apoE2*, apoE2**, apoE3, and apoE4) that has one or more amino acid substitutions in the carboxy-terminal region which, when administered to a mammal having hypercholesterolemia, reduces the plasma cholesterol levels without inducing hypertriglyceridemia. The invention also provides a method for reducing plasma cholesterol using low doses of naturally-occurring apoE proteins.

Claims (25)

1. A method for reducing plasma cholesterol in a mammal, without inducing hypertriglyceridemia, said method comprising administering to said mammal a therapeutic apoE protein comprising a sequence having at least 95% sequence identity to SEQ ID NO: 1 and at least one amino acid substitution in the carboxy-terminal region.

2. The method of claim 1 , wherein said mammal is a human.

3. The method of claim 1 , wherein said therapeutic apoE protein comprises at least one amino acid substitution selected from the group consisting of L261X, W264X, F265X, L268X, and V269X, wherein X is any amino acid.

4. The method of claim 3 , wherein X is alanine.

5. The method of claim 1 , wherein said therapeutic apoE protein comprises at least one amino acid substitution selected from the group consisting of L261A, W264A, F265A, L268A, and V269A.

6. The method of claim 5 , wherein said therapeutic apoE protein comprises the amino acid substitutions L261A, W264A, F265A, L268A, and V269A.

7. The method of claim 1 , wherein said therapeutic apoE protein is apoE4.

8. The method of claim 1 , wherein said therapeutic apoE protein comprises at least one amino acid substitution selected from the group consisting of W276X, L279X, V283X, V287X, and V293X, wherein X is any amino acid.

9. The method of claim 8 , wherein X is alanine.

10. The method of claim 1 , wherein said therapeutic apoE protein comprises at least one amino acid substitution selected from the group consisting of W276A, L279A, V283A, V287A, and V293A.

11. The method of claim 10 , wherein said therapeutic apoE protein comprises the amino acid substitutions W276A, L279A, V283A, V287A, and V293A.

12. The method of claim 1 , wherein said therapeutic apoE protein is apoE4.

13. The method of claim 1 , wherein said therapeutic apoE protein is administered by intravenous injection.

14. A therapeutic apoE protein comprising a sequence having at least 95% sequence identity to SEQ ID NO: 1 and at least one amino acid substitution in the carboxy-terminal region, wherein said protein when administered to a mammal is capable of lowering the total serum cholesterol levels without inducing hypertriglyceridemia.

15. The therapeutic apoE protein of claim 14 , wherein said therapeutic apoE protein comprises at least one amino acid substitution selected from the group consisting of L261X, W264X, F265X, L268X, and V269X, wherein X is any amino acid.

16. The therapeutic apoE protein of claim 15 , wherein X is alanine.

17. The therapeutic apoE protein of claim 14 , wherein said therapeutic apoE protein comprises at least one amino acid substitution selected from the group consisting of L261A, W264A, F265A, L268A, and V269A.

18. The therapeutic apoE protein of claim 17 , wherein said therapeutic apoE protein comprises the amino acid substitutions L261A, W264A, F265A, L268A, and V269A.

19. The therapeutic apoE protein of claim 14 , wherein said therapeutic apoE protein is apoE4.

20. The therapeutic apoE protein of claim 14 , wherein said therapeutic apoE protein comprises at least one amino acid substitution selected from the group consisting of W276X, L279X, V283X, V287X, and V293X, wherein X is any amino acid.

21. The therapeutic apoE protein of claim 20 , wherein X is alanine.

22. The therapeutic apoE protein of claim 1 , wherein said therapeutic apoE protein comprises at least one amino acid substitution selected from the group consisting of W276A, L279A, V283A, V287A, and V293A.

23. The therapeutic apoE protein of claim 22 , wherein said therapeutic apoE protein comprises the amino acid substitutions W276A, L279A, V283A, V287A, and V293A.

24. The therapeutic apoE protein of claim 14 , wherein said therapeutic apoE protein is apoE4.

25. The therapeutic apoE protein of claim 17 , wherein said therapeutic apoE protein comprises the amino acid substitutions L261A, W264A, and F265A.

Assignments (4)
CONFIRMATORY LICENSE Recorded Aug 16, 2010
From: BOSTON UNIVERSITY MEDICAL CAMPUS
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 024838/0229 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 5, 2010
From: KOS PHARMACEUTICALS
To: TRUSTEES OF BOSTON UNIVERSITY
Reel/Frame 024630/0594 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 24, 2006
From: KOS PHARMACEUTICALS, INC.
To: KOS LIFE SCIENCES, INC
Reel/Frame 018160/0475 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2005
From: ZANNIS, VASSILIS I.; KYPREOS, KYRIAKOS E.
To: TRUSTEES OF BOSTON UNIVERSITY, THE; KOS PHARMACEUTICALS, INC.
Reel/Frame 017138/0052 →
Continuity (2)
Provisional Application 6060753000 · Sep 7, 2004
Related Publication 20060079446A1 · Apr 13, 2006