Claims for Patent: 9,795,604

Summary for Patent: 9,795,604

Title:	Methods of treating and preventing graft versus host disease
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.
Inventor(s):	Byrd; John C. (Columbus, OH), Dubovsky; Jason A. (Columbus, OH), Muthusamy; Natarajan (Galloway, OH), Johnson; Amy Jo (Dublin, OH), Miklos; David (Stanford, CA)
Assignee:	Pharmacyclics LLC (Sunnyvale, CA)
Application Number:	14/523,650
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,795,604
Patent Claims:	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: ##STR00034## 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: ##STR00035## 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: ##STR00036##