Claims for Patent: 9,598,486

Summary for Patent: 9,598,486

Title:	Methods for treating osteogenesis imperfecta
Abstract:	The present invention provides methods for treating and improving the symptoms of osteogenesis imperfecta (OI) in a subject by administering to the subject a therapeutically effective amount of a binding agent that binds to transforming growth factor beta (TGF.beta.).
Inventor(s):	Lee; Brendan (Houston, TX), Sampath; Kuber T. (Holliston, MA)
Assignee:	GENZYME CORPORATION (Cambridge, MA) BAYLOR COLLEGE OF MEDICINE (Houston, TX)
Application Number:	14/772,708
Patent Claims:	1. A method for treating osteogenesis imperfecta (OI) in a subject in need thereof comprising administering to the subject a therapeutically effective amount of an antibody or an antigen binding fragment thereof that binds to transforming growth factor beta (TGF.beta.). 2. The method of claim 1, wherein the antibody or antigen binding fragment thereof comprises a heavy chain variable region comprising three complementarity determining regions (CDRs) having amino acid sequences selected from the group consisting of SEQ ID NOs: 4, 5, and 6; and a light chain variable region comprising three CDRs having amino acid sequences selected from the group consisting of SEQ ID NOs: 7, 8, and 9. 3. The method of claim 1, wherein the antibody or antigen binding fragment thereof comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 10, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 11. 4. The method of claim 1, wherein the antibody or antigen binding fragment thereof further comprises a human IgG4 constant region. 5. The method of claim 4, wherein the human IgG4 constant region comprises the amino acid sequence of SEQ ID NO: 12. 6. The method of claim 1, wherein the antibody or antigen binding fragment thereof further comprises a human .kappa. light chain constant region. 7. The method of claim 6, wherein the human .kappa. light chain constant region comprises the amino acid sequence of SEQ ID NO: 13. 8. The method of claim 1, wherein the antibody or antigen binding fragment thereof further comprises a human IgG4 constant region, and a human .kappa. light chain constant region. 9. The method of claim 8, wherein the human IgG4 constant region comprises the amino acid sequence of SEQ ID NO: 12, and the human .kappa. light chain constant region comprises the amino acid sequence of SEQ ID NO: 13. 10. The method of claim 1, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 14. 11. The method of claim 1, wherein the antibody comprises a light chain comprising the amino acid sequence of SEQ ID NO: 15. 12. The method of claim 1, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 14, and a light chain comprising the amino acid sequence of SEQ ID NO: 15. 13. The method of claim 1, wherein the antibody or antigen binding fragment thereof binds to human TGF.beta.1, TGF.beta.2, and TGF.beta.3. 14. The method of claim 1, wherein the antibody or antigen binding fragment thereof neutralizes human TGF.beta.1, TGF.beta.2, and TGF.beta.3. 15. The method of claim 1, wherein the antibody or antigen binding fragment thereof improves a bone parameter selected from the group consisting of bone volume density (BV/TV), total bone surface (BS), bone surface density (BS/BV), trabecular number (Tb.N), trabecular thickness (Tb.Th), trabecular spacing (Tb.Sp), and total volume (Dens TV). 16. The method of claim 1, wherein the antibody or antigen binding fragment thereof reduces a serum biomarker of bone resorption selected from the group consisting of urinary hydroxyproline, urinary total pyridinoline (PYD), urinary free deoxypyridinoline (DPD), urinary collagen type-I cross-linked N-telopeptide (NTX), urinary or serum collagen type-I cross-linked C-telopeptide (CTX), bone sialoprotein (BSP), osteopontin (OPN), and tartrate-resistant acid phosphatase 5b (TRAP). 17. The method of claim 1, wherein the antibody or antigen binding fragment thereof increases a serum biomarker of bone deposition selected from the group consisting of total alkaline phosphatase, bone-specific alkaline phosphatase, osteocalcin, and type-I procollagen (C-terminal/N-terminal). 18. The method of claim 1, wherein the antibody or antigen binding fragment thereof inhibits bone resorption. 19. The method of claim 1, wherein the antibody or antigen binding fragment thereof promotes bone deposition. 20. The method of claim 1, wherein the antibody or antigen binding fragment thereof improves a lung function affected by OI. 21. A method for treating osteogenesis imperfecta (0I) in a subject in need thereof comprising administering to the subject a therapeutically effective amount of an antibody or an antigen binding fragment thereof that binds to transforming growth factor beta (TGF.beta.), wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 14, and a light chain comprising the amino acid sequence of SEQ ID NO: 15. 22. A method for treating osteogenesis imperfecta (OI) in a subject in need thereof comprising administering to the subject a therapeutically effective amount of an antibody or an antigen binding fragment thereof that binds to transforming growth factor beta (TGF.beta.) in combination with at least one therapeutic agent. 23. The method of claim 22, wherein the agent is selected from the group consisting of a bisphosphonate, parathyroid hormone or a parathyroid hormone analog, calcitonin, and a selective estrogen receptor modulator (SERM). 24. The method of claim 22, wherein the agent is parathyroid hormone or a parathyroid hormone analog. 25. The method of claim 24, wherein the subject has type I OI.

Details for Patent 9,598,486

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2033-03-20