Claims for Patent: 7,318,925

Summary for Patent: 7,318,925

Title:	Methods of use for antibodies against parathyroid hormone
Abstract:	Embodiments of the invention described herein relate to antibodies directed to the antigen parathyroid hormone (PTH) and uses of such antibodies. In particular, in some embodiments, there are provided fully human monoclonal antibodies directed to the antigen PTH. In further embodiments, nucleotide sequences encoding, and amino acid sequences comprising, heavy and light chain immunoglobulin molecules, particularly sequences corresponding to contiguous heavy and light chain sequences spanning the framework regions and/or complementarity determining regions (CDRs), specifically from FR1 through FR4 or CDR1 through CDR3, are provided.
Inventor(s):	Roskos; Lorin (Pleasanton, CA), Foltz; Ian (Burnaby, CA), King; Chadwick (Vancouver, CA), Bell; Gregory (Tiburon, CA)
Assignee:	Amgen Fremont, Inc. (Fremont, CA)
Application Number:	10/956,008
Patent Claims:	1. A method of reducing elevated circulating levels of parathyroid hormone (PTH) in a patient, comprising: identifying a patient in need of treatment for elevated circulating levels of PTH; and administering to said patient a therapeutically effective dose of a fully human monoclonal antibody, or binding fragment thereof, that binds with an affinity to PTH of less than 100 pM, and reduces the circulating levels of PTH below 300 pG/ml for at least about seven days, wherein said fully human monoclonal antibody is mAb 183. 2. The method of claim 1, wherein said elevated circulating levels of PTH are associated with hyperparathyroidism. 3. The method of claim 2, wherein said hyperparathyroidism is primary hyperparathyroidism. 4. The method of claim 2, wherein said hyperparathyroidism is secondary hyperparathyroidism. 5. The method of claim 1, further comprising treating said patient with a second fully human monoclonal antibody or binding fragment thereof that binds to PTH. 6. The method of claim 5, wherein said second fully human monoclonal antibody or binding fragment thereof binds amino acids 1-7 of PTH. 7. A method of effectively treating hypercalcemia in a patient, comprising: identifying a patient in need of treatment for hypercalcemia; administering to said patient a therapeutically effective dose of a first fully human monoclonal antibody or binding fragment thereof that specifically binds to parathyroid hormone (PTH), wherein the administration of said monoclonal antibody or binding fragment thereof reduces serum calcium levels below 12 mg/dL, and wherein said patient is a human; and treating said patient with a second fully human monoclonal antibody or binding fragment thereof that binds to PTH, wherein said second fully human monoclonal antibody is mAb sc275. 8. A method of effectively treating hypercalcemia in a patient, comprising: identifying a patient in need of treatment for hypercalcemia; and administering to said patient a therapeutically effective dose of a fully human monoclonal antibody or binding fragment thereof that specifically binds to parathyroid hormone (PTH), wherein the administration of said monoclonal antibody or binding fragment thereof reduces serum calcium levels below 12 mg/dL, and wherein said patient is a human, wherein said fully human monoclonal antibody is mAb 183. 9. A method of effectively treating parathyroid carcinoma in a patient, comprising: identifying a patient in need of treatment for parathyroid carcinoma; administering to said patient a therapeutically effective dose of a first fully human monoclonal antibody or binding fragment thereof that specifically binds to parathyroid hormone (PTH); wherein the administration of said antibody or binding fragment thereof results in the sustained reduction of circulating PTH below 300 pg/ml for a period of at least three days, and wherein said patient is a human; and treating said patient with a second fully human monoclonal antibody or binding fragment thereof that binds to PTH, wherein said second fully human monoclonal antibody is mAb sc275. 10. A method of effectively treating parathyroid carcinoma in a patient, comprising: identifying a patient in need of treatment for parathyroid carcinoma; and administering to said patient a therapeutically effective dose of a fully human monoclonal antibody or binding fragment thereof that specifically binds to parathyroid hormone (PTH); wherein the administration of said antibody or binding fragment thereof results in the sustained reduction of circulating PTH below 300 pg/ml for a period of at least three days, and wherein said patient is a human, wherein said fully human monoclonal antibody is mAb 183. 11. The method of claim 1 wherein said binding fragment is selected from the group consisting of Fab, Fab', F(ab').sub.2, and F.sub.v. 12. The method of claim 8, wherein said binding fragment is selected from the group consisting of Fab, Fab', F(ab').sub.2, and F.sub.v. 13. The method of claim 10, wherein said binding fragment is selected from the group consisting of Fab, Fab', F(ab').sub.2, and F.sub.v. 14. The method of claim 1, wherein said PTH levels are reduced below 200 pg/ml. 15. The method of claim 9, wherein the PTH is reduced for at least seven days. 16. The method of claim 9, wherein the PTH is reduced for at least eleven days. 17. The method of claim 1, wherein the PTH is reduced for at least eleven days. 18. The method of claim 10, wherein the PTH is reduced for at least seven days. 19. The method of claim 10, wherein the PTH is reduced for at least eleven days. 20. The method of claim 7, wherein said binding fragment of said first fully human monoclonal antibody is selected from the group consisting of Fab, Fab', F(ab').sub.2, and F.sub.v. 21. The method of claim 7, wherein said binding fragment of said second fully human monoclonal antibody is selected from the group consisting of Fab, Fab', F(ab').sub.2, and F.sub.v. 22. The method of claim 7, wherein said first fully human monoclonal antibody is mAb183. 23. The method of claim 9, wherein said binding fragment of said first fully human monoclonal antibody is selected from the group consisting of Fab, Fab', F(ab').sub.2, and F.sub.v. 24. The method of claim 9, wherein said binding fragment of said second fully human monoclonal antibody is selected from the group consisting of Fab, Fab', F(ab').sub.2, and F.sub.v. 25. The method of claim 9, wherein said first fully human monoclonal antibody is mAb183. 26. The method of claim 5, wherein said second fully human monoclonal antibody is mAb sc275. 27. The method of claim 5, wherein said binding fragment of said second fully human monoclonal antibody is selected from the group consisting of Fab, Fab', F(ab').sub.2, and F.sub.v.

Details for Patent 7,318,925

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2023-08-08