Claims for Patent: 7,037,900

Summary for Patent: 7,037,900

Title:	Composition and method for treating graft-versus-host disease
Abstract:	Compositions and methods are provided for prevention and clinical treatment of various forms of graft-versus-host disease (GVHD) by using inhibitors of adenosine deaminase (ADA). In particular, various formulations and dosing regimens of ADA inhibitors such as pentostatin are provided for the treatment of humans in vivo as well as for ex vivo conditioning of organ transplants in order to specifically suppress T-lymphocyte mediated immune responses while minimizing systemic toxicity of the drug.
Inventor(s):	DiMartino; Jorge (San Carlos, CA), Nelson; John Tippett (Danville, CA)
Assignee:	SuperGen, Inc. (Dublin, CA)
Application Number:	09/976,468
Patent Claims:	1. A method for reducing the risk of developing graft-versus-host disease in a human patient who is a recipient of an organ or tissue transplant, composing: treating the patient with myeloablative conditioning regimen; and administering to the transplant recipient pentostatin in a pharmaceutically effective amount within a predetermined time window before the transplantation. 2. The method claim 1, wherein the transplant recipient is transplanted with bone marrow. 3. The method of claim 1, wherein the transplant recipient is transplanted with hematopoietic stem cells. 4. The method of claim 1, wherein pentostatin is administered orally to the transplant recipient. 5. The method of claim 1, wherein pentostatin is administered parenterally to the transplant recipient. 6. The method of claim 1, wherein pentostatin is administered to the transplant recipient by intravenous infusion at a dose of about 1 10 mg/m.sup.2. 7. The method of claim 1, wherein pentostatin is administered to the transplant recipient by intravenous infusion at a dose of about 2 6 mg/m.sup.2. 8. The method of claim 1, wherein pentostatin is administered to the transplant recipient by intravenous infusion at a dose of about 2 mg/m.sup.2. 9. The method of claim 1, wherein pentostatin is administered to the transplant recipient by intravenous infusion at a dose of about 1 mg/m.sup.2. 10. The method of claim 1, further comprising: administering to the transplant recipient an immunosuppressive agent selected from the group consisting of prednisone, methylprednisolone, cyclophosphamide, cyclosporin A, FK506, thalidomide, azathioprine, Daclizumab, Infliximab, MEDI-205, abx-cbl and ATG. 11. The method of claim 1, wherein pentostatin is administered to the patient 2 or 3 days before the transplantation. 12. A method for preventing or reducing the risk of developing graft-versus-host disease in a patient who is a recipient of an organ or tissue transplant, comprising: administering to the transplant recipient pentostatin in a pharmaceutically effective amount of about 1 10 mg/m2 within a predetermined time window after the transplantation. 13. The method claim 12, wherein the transplant recipient is transplanted with bone marrow, stem cells, heart, liver, kidney, lung, pancreas, small intestine, cornea, or skin. 14. The method of claim 12, wherein the transplant recipient is transplanted with hematopoietic stem cells. 15. The method of claim 12, wherein the transplant patient is treated in a myeloablative or non-myeloablative conditioning regimen. 16. The method of claim 12, wherein pentostatin is administered orally to the transplant recipient. 17. The method of claim 12, wherein pentostatin is administered parenterally to the transplant recipient. 18. The method of claim 12, wherein pentostatin is administered to the transplant recipient by intravenous infusion at a dose of about 1 10 mg/m.sup.2. 19. The method of claim 12, wherein pentostatin is administered to the transplant recipient by intravenous infusion at a dose of about 2 6 mg/m.sup.2. 20. The method of claim 12, wherein pentostatin is administered to the transplant recipient by intravenous infusion at a dose of 2 mg/m.sup.2. 21. The method of claim 12, wherein pentostatin is administered to the transplant recipient by intravenous infusion at a dose of about 1 mg/m.sup.2. 22. The method of claim 12, further comprising: administering to the transplant recipient an immunosuppressive agent selected from the group consisting of prednisone, methylprednisolone, cyclophosphamide, cyclosporin A, FK506, thalidomide, azathioprine, Daclizumab, Infliximab, MEDI-205, abx-cbl and ATG. 23. The method of claim 1, wherein pentostatin is administered to the patient 2 or 3 days before the transplantation. 24. The method of claim 12, wherein pentostatin is administered to the transplant recipient at about 1.5 mg/m.sup.2/day on day +8 following the transplantation. 25. The method of claim 25, wherein the transplant is hematopoietic stem cells or bone marrow. 26. The method of claim 12, wherein the transplant is hematopoietic stem cells or bone marrow. 27. The method of claim 27, wherein the transplant is hematopoietic stem cells or bone marrow. 28. The method of claim 12, wherein pentostatin is administered to the transplant recipient at about 1.5 mg/m.sup.2/day on days +8, +15, and +22 following the transplantation. 29. The method of claim 29, wherein the transplant is hematopoietic stem cells or bone marrow. 30. The method of claim 12, wherein pentostatin is administered to the transplant recipient at about 1.5 mg/m.sup.2/day on days +8, +15, +22 and +30 following the transplantation. 31. The method of claim 31, wherein the transplant is hematopoietic stem cells or bone marrow. 32. The method of claim 12, wherein the transplant recipient is transplanted with hematopoietic stem cells and treated in a myeloablative conditioning regimen. 33. The method of claim 12, wherein pentostatin is administered intravenously to the transplant recipient at 1 2 mg/m.sup.2/day on days +8, following the transplantation. 34. The method of claim 12, wherein pentostatin is administered intravenously to the transplant recipient at 1 2 mg/m.sup.2/day on day +15 following the transplantation. 35. The method of claim 12, wherein pentostatin is administered intravenously to the transplant recipient at 1 2 mg/m.sup.2/day on days +8 and +15 following the transplantation. 36. The method of claim 12, wherein pentostatin is administered intravenously to the transplant recipient at 1 2 mg/m.sup.2/day on days +8 and +15 following the transplantation. 37. The method of claim 37, wherein the transplant is myeloablative transplant. 38. The method of claim 37, wherein the transplant is non-myeloablative transplant. 39. The method of claim 12, wherein pentostatin is administered intravenously to the transplant recipient at 1.5 mg/m.sup.2/day on days +8, +15, +22, and +30 following the transplantation.

Details for Patent 7,037,900

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2039-02-26
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2039-02-26
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016		2039-02-26
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017		2039-02-26