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Last Updated: March 28, 2024

Claims for Patent: 9,895,428


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Summary for Patent: 9,895,428
Title:Methods of treating antibody-mediated rejection in organ transplant patients with C1-esterase inhibitor
Abstract: A method and composition for treating or preventing antibody-mediated rejection (AMR) of a transplanted organ are provided.
Inventor(s): Broom; Colin (Devon, PA), Uknis; Marc E. (Chadds Ford, PA)
Assignee: Shire Viropharma Incorporated (Lexington, MA)
Application Number:14/550,075
Patent Claims:1. A method of treating antibody-mediated rejection (AMR) of an organ allograft in a patient in need thereof, the method comprising administration of a C1 esterase inhibitor (C1-INH) protein at a dose of about 20,000 units given in divided doses over a duration of about 1 to 30 days, wherein the administration is initiated within 1 to 90 days of organ transplantation, treatment with plasmapheresis, treatment with intravenous immunoglobulin (IVIg), or diagnosis of AMR of the patient, wherein the method results in a therapeutic effect lasting for at least 3 months after cessation of therapy.

2. The method of claim 1, further comprising subjecting the patient to plasmapheresis.

3. The method of claim 1, further comprising administering fresh frozen plasma.

4. The method of claim 1 further comprising administering intravenous immunoglobulin.

5. The method of claim 1, further comprising administering an anti-lymphocyte preparation, rituximab, bortezomib, eculizumab, or a combination thereof.

6. The method of claim 1 wherein the organ is a solid organ.

7. The method of claim 6, wherein the solid organ is selected from the group consisting of kidney, pancreas, intestine, heart, lung, and liver.

8. The method of claim 7, wherein the solid organ is a kidney.

9. The method of claim 1, wherein the C1-INH protein is plasma-derived or recombinant.

10. The method of claim 1, wherein the duration is about 10-20 days.

11. The method of claim 1, wherein the duration is 13 days.

12. The method of claim 1, wherein the therapeutic effect comprises the prevention of AMR.

13. The method of claim 1, wherein the administration is initiated within about 5 to 10 days of organ transplantation, treatment with plasmapheresis, treatment with IVIg, or diagnosis of AMR.

14. A method of treating antibody-mediated rejection (AMR) of a kidney allograft in a patient in need thereof, the method comprising administration of a C1 esterase inhibitor (C1-INH) protein at a dose of about 20,000 units given in divided doses over a duration of about 1 to 30 days, wherein the administration is initiated within 1 to 90 days of organ transplantation, treatment with plasmapheresis, treatment with intravenous immunoglobulin (IVIg), or diagnosis of AMR of the patient, wherein the method results in a therapeutic effect lasting for at least 3 months after cessation of therapy.

15. The method of claim 14, wherein the C1-INH protein is plasma-derived or recombinant.

16. The method of claim 14, further comprising subjecting the patient to plasmapheresis.

17. The method of claim 14, further comprising administering fresh frozen plasma.

18. The method of claim 14, further comprising administering intravenous immunoglobulin.

19. The method of claim 14, further comprising administering an anti-lymphocyte preparation, rituximab, bortezomib, eculizumab, or a combination thereof.

20. The method of claim 14, wherein the therapeutic effect comprises improvement in renal function.

21. The method of claim 14, wherein the therapeutic effect comprises the prevention of AMR.

22. The method of claim 14, wherein the therapeutic effect comprises the treatment or prevention of chronic or transplant glomerulopathy.

23. The method of claim 14, wherein the administration is initiated within 5 to 10 days of one of organ transplantation, treatment with plasmapheresis, treatment with IVIg, or diagnosis of AMR.

24. The method of claim 14, wherein the duration is from about 10-20-days.

25. The method of claim 14, wherein the duration is 13 days.

26. The method of claim 2, further comprising administering IVIg.

27. The method of claim 16, further comprising administering IVIg.

Details for Patent 9,895,428

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2033-11-22
Alexion Pharmaceuticals, Inc. SOLIRIS eculizumab Injection 125166 03/16/2007 ⤷  Try a Trial 2033-11-22
Genentech, Inc. RITUXAN HYCELA rituximab and hyaluronidase human Injection 761064 06/22/2017 ⤷  Try a Trial 2033-11-22
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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