IP Library Granted Patent US 9,795,604
Granted Patent B2
US 9,795,604 · App. 14/523,650 · Granted Oct 24, 2017

Methods of treating and preventing graft versus host disease

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Quick Facts
Patent No.
US 9,795,604
App. No.
14/523,650
Granted
Oct 24, 2017
Kind
B2
Abstract

Described herein are methods for treating and preventing graft versus host disease using ACK inhibitors. The methods include administering to an individual in need thereof an ACK inhibitor such as ibrutinib for treating and preventing graft versus host disease.

Claims (56)

1. A method of treating chronic graft versus host disease (GVHD) comprising administering to a patient having chronic GVHD a therapeutically effective amount of a compound of the structure:

thereby treating the chronic GVHD in the patient.

2. The method of claim 1 , wherein the patient has classic chronic GVHD.

3. The method of claim 1 , wherein the patient has overlap chronic GVHD.

4. The method of claim 1 , wherein the patient has steroid-dependent/refractory chronic GVHD.

5. The method of claim 1 , wherein the therapeutically effective amount of the compound is about 40 mg/day, about 140 mg/day, about 280 mg/day, about 420 mg/day, about 560 mg/day, or about 840 mg/day.

6. The method of claim 1 , wherein, following administration of the compound, the patient achieves partial response (PR), wherein the PR is an objective response in one involved organ in the patient with no evidence of progression elsewhere and no requirements for additional systemic therapy.

7. The method of claim 1 , wherein, following administration of the compound, the patient achieves complete response (CR), wherein the CR is a complete restoration of symptoms attributable to GVHD.

8. The method of claim 1 , wherein, following administration of the compound, the severity of the GVHD is reduced.

9. The method of claim 1 , wherein the patient has chronic lymphocytic leukemia (CLL).

10. The method of claim 1 , wherein the patient had a hematopoietic cell transplantation.

11. The method of claim 1 , wherein the chronic GVHD is sclerodermatous GVHD, steroid resistant GVHD, cyclosporin-resistant GVHD, refractory GVHD, oral GVHD, reticular oral GVHD, erosive GVHD, or ulcerative oral GVHD.

12. The method of claim 1 , wherein the chronic GVHD is sclerodermatous GVHD.

13. The method of claim 1 , wherein the chronic GVHD is steroid resistant GVHD.

14. The method of claim 1 , wherein the chronic GVHD is cyclosporin-resistant GVHD.

15. The method of claim 1 , wherein the chronic GVHD is refractory GVHD.

16. The method of claim 1 , wherein the chronic GVHD is oral GVHD.

17. The method of claim 1 , wherein the chronic GVHD is reticular oral GVHD.

18. The method of claim 1 , wherein the chronic GVHD is erosive GVHD.

19. The method of claim 1 , wherein the chronic GVHD is ulcerative oral GVHD.

20. The method of claim 1 , wherein about 420 mg/day of the compound is administered.

21. The method of claim 1 , wherein about 420 mg of the compound is administered once per day.

22. The method of claim 1 , wherein the compound is administered orally.

23. The method of claim 1 , wherein about 420 mg/day of the compound is administered orally.

24. The method of claim 1 , wherein about 420 mg of the compound is administered orally once per day.

25. The method of claim 4 , wherein about 420 mg/day of the compound is administered.

26. The method of claim 4 , wherein about 420 mg of the compound is administered once per day.

27. The method of claim 4 , wherein about 420 mg/day of the compound is administered orally.

28. The method of claim 4 , wherein about 420 mg of the compound is administered orally once per day.

29. The method of claim 4 , wherein, following administration of the compound, the patient achieves partial response (PR), wherein the PR is an objective response in one involved organ in the patient with no evidence of progression elsewhere and no requirements for additional systemic therapy.

30. The method of claim 4 , wherein, following administration of the compound, the patient achieves complete response (CR), wherein the CR is a complete restoration of symptoms attributable to GVHD.

31. The method of claim 4 , wherein, following administration of the compound, the severity of the GVHD is reduced.

32. The method of claim 6 , wherein about 420 mg/day of the compound is administered.

33. The method of claim 6 , wherein about 420 mg of the compound is administered once per day.

34. The method of claim 6 , wherein about 420 mg/day of the compound is administered orally.

35. The method of claim 6 , wherein about 420 mg of the compound is administered orally once per day.

36. The method of claim 7 , wherein about 420 mg/day of the compound is administered.

37. The method of claim 7 , wherein about 420 mg of the compound is administered once per day.

38. The method of claim 7 , wherein about 420 mg/day of the compound is administered orally.

39. The method of claim 7 , wherein about 420 mg of the compound is administered orally once per day.

40. The method of claim 13 , wherein about 420 mg/day of the compound is administered.

41. The method of claim 13 , wherein about 420 mg of the compound is administered once per day.

42. The method of claim 13 , wherein about 420 mg/day of the compound is administered orally.

43. The method of claim 13 , wherein about 420 mg of the compound is administered orally once per day.

44. The method of claim 13 , wherein, following administration of the compound, the patient achieves partial response (PR), wherein the PR is an objective response in one involved organ in the patient with no evidence of progression elsewhere and no requirements for additional systemic therapy.

45. The method of claim 13 , wherein, following administration of the compound, the patient achieves complete response (CR), wherein the CR is a complete restoration of symptoms attributable to GVHD.

46. The method of claim 13 , wherein, following administration of the compound, the severity of the GVHD is reduced.

47. The method of claim 15 , wherein about 420 mg/day of the compound is administered.

48. The method of claim 15 , wherein about 420 mg of the compound is administered once per day.

49. The method of claim 15 , wherein about 420 mg/day of the compound is administered orally.

50. The method of claim 15 , wherein about 420 mg of the compound is administered orally once per day.

51. The method of claim 15 , wherein, following administration of the compound, the patient achieves partial response (PR), wherein the PR is an objective response in one involved organ in the patient with no evidence of progression elsewhere and no requirements for additional systemic therapy.

52. The method of claim 15 , wherein, following administration of the compound, the patient achieves complete response (CR), wherein the CR is a complete restoration of symptoms attributable to GVHD.

53. The method of claim 15 , wherein, following administration of the compound, the severity of the GVHD is reduced.

54. A method of treating chronic graft versus host disease (GVHD) comprising administering to a patient having chronic GVHD from 140 mg/day to 840 mg/day of a compound of the structure:

55. A method of treating chronic graft versus host disease (GVHD) comprising administering to a patient having chronic GVHD about 420 mg/day of a compound of the structure:

Assignments (10)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 3, 2017
From: MIKLOS, DAVID
To: THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY
Reel/Frame 040824/0661 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 3, 2017
From: THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY
To: PHARMACYCLICS LLC
Reel/Frame 040824/0664 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 3, 2017
From: DUBOVSKY, JASON
To: OHIO STATE INNOVATION FOUNDATION
Reel/Frame 040824/0667 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 3, 2017
From: BYRD, JOHN; JOHNSON, AMY; MUTHUSAMY, NATARAJAN
To: OHIO STATE INNOVATION FOUNDATION
Reel/Frame 040824/0670 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 3, 2017
From: OHIO STATE INNOVATION FOUNDATION
To: PHARMACYCLICS LLC
Reel/Frame 040827/0616 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY DATA PREVIOUSLY RECORDED ON REEL 036126 FRAME 0368. ASSIGNOR(S) HEREBY CONFIRMS THE MERGER AND CHANGE OF NAME. Recorded May 18, 2016
From: PHARMACYCLICS, INC.; OXFORD AMHERST LLC
To: PHARMACYCLICS LLC
Reel/Frame 038742/0371 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY DATA PREVIOUSLY RECORDED ON REEL 036126 FRAME 0359. ASSIGNOR(S) HEREBY CONFIRMS THE MERGER. Recorded May 17, 2016
From: OXFORD AMHERST CORPORATION; PHARMACYCLICS, INC.
To: PHARMACYCLICS, INC.
Reel/Frame 038742/0064 →
MERGER Recorded Jul 16, 2015
From: OXFORD AMHERST CORPORATION
To: PHARMACYCLICS, INC.
Reel/Frame 036126/0359 →
MERGER AND CHANGE OF NAME Recorded Jul 16, 2015
From: PHARMACYCLICS, INC.; OXFORD AMHERST LLC
To: PHARMACYCLICS LLC
Reel/Frame 036126/0368 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 29, 2015
From: MIKLOS, DAVID; BYRD, JOHN C.; DUBOVSKY, JASON A.; MUTHUSAMY, NATARAJAN; JOHNSON, AMY JO
To: PHARMACYCLICS, INC.
Reel/Frame 035748/0009 →