Claims for Patent: 8,022,036

Summary for Patent: 8,022,036

Title:	Use of thymosin alpha 1 for the treatment of immunological diseases
Abstract:	It is described the use of thymosin alpha 1 for preparing a medicament useful for the prevention or treatment of graft-versus-host disease or graft rejection reactions in organ transplantation, in a mammal subject, in which the cells, tissues or organs for transplant is selected from the group comprising: stem cells, hematopoietic stem cells, bone marrow, heart, liver, kidney, lung, pancreas, small intestine, cornea or skin.
Inventor(s):	Romani; Luigina (Perugia, IT), Bistoni; Francesco (Perugia, IT), Garaci; Enrico (Rome, IT)
Assignee:	Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. (Rome, IT)
Application Number:	12/272,573
Patent Claims:	1. Method of treating or inhibiting graft-versus-host disease in a mammalian subject, comprising administering an effective amount of thymosin alpha 1 to a mammalian subject suffering from graft-versus-host disease, wherein said effective amount of thymosin alpha 1 is capable of treating or inhibiting said graft-versus-host disease in said mammalian subject and wherein said mammalian subject is the recipient of transplanted cells selected from the group consisting of: stem cells, hematopoietic stem cells and bone marrow. 2. Method according to claim 1, in which the mammalian subject is a human patient. 3. Method according to claim 1, in which the mammalian subject is in myeloablative conditioning regimen. 4. Method according to claim 1, in which the mammalian subject is in a non-myeloablative conditioning regimen. 5. Method according to claim 1, in which the thymosin alpha 1 is administered to the mammalian subject in a pharmaceutically effective amount within a predetermined time window before and/or after the transplantation. 6. Method according to claim 1, in which thymosin alpha 1 is administered to the mammalian subject in combination with an immunosuppressive agent selected from the group consisting of prednisone, methylprednisolone, cyclophosphamide, cyclosporin A, FK506, thalimdomide, azathioprine, Daclizumab, Infliximab, MEDI-205, abx-cbl and ATG. 7. Method according to claim 1, in which the thymosin alpha 1 is administered to the mammalian subject in a dose of from about 10 to 400 .mu.g/kg body weight per day. 8. Method according to claim 7, in which thymosin alpha 1 is administered to the mammalian subject in a dose of from about 40 to 400 .mu.g/kg body weight per day. 9. Method according to claim 8, in which the thymosin alpha 1 is administered to the mammalian subject in a dose of from about 200 to 400 .mu.g/kg body weight per day. 10. Method according to claim 1, in which the thymosin alpha 1 is administered to the mammalian subject in a dose of from about 0.8 to 16 mg per day. 11. Method according to claim 10, in which thymosin alpha 1 is administered to the mammalian subject in a dose of from about 0.8 to 6.4 mg per day. 12. Method according to claim 11, in which the thymosin alpha 1 is administered to the mammalian subject in a dose of from about 1.4 to 2.8 mg per day. 13. Method according to claim 12, in which the thymosin alpha 1 is administered to the mammalian subject in a dose of about 1.6 mg per day. 14. Method according to claim 1, wherein thymosin alpha 1 is administered to the mammalian subject via subcutaneous injection.

Details for Patent 8,022,036

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2026-05-19
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2026-05-19
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016		2026-05-19
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017		2026-05-19