Claims for Patent: 7,056,882

Summary for Patent: 7,056,882

Title:	Treatment to prevent loss of and/or increase bone mass in metabolic bone diseases
Abstract:	The invention is a treatment for increasing the bone mass or preventing bone loss in an individual afflicted with a bone disease which includes administering to the individual a morphogen in a therapeutically effective amount so as to maintain or stimulate bone formation.
Inventor(s):	Kuberasampath; Thangavel (Medway, MA), Cohen; Charles M. (Weston, MA), Oppermann; Herrmann (Medway, MA), Ozkaynak; Engin (Milford, MA), Rueger; David C. (Hopkinton, MA), Smart; John E. (Weston, MA), Pang; Roy H. L. (Etna, NH)
Assignee:	Curis, Inc. (Cambridge, MA)
Application Number:	09/952,318
Patent Claims:	1. A therapeutic treatment method for preventing loss of bone mass or increasing bone mass in an individual, the method comprising: systemically administering to the individual a therapeutically effective morphogen in an amount and for a time sufficient to prevent loss of or to increase bone mass in said individual, wherein the morphogen comprises an amino acid sequence selected from the group consisting of a sequence: (a) having at least 70% homology with the C-terminal seven-cysteine skeleton of human OP-1 as set forth in residues 330-431 of SEQ ID NO: 5; (b) having greater than 60% amino acid sequence identity with said C-terminal seven-cysteine skeleton of human OP-1; and (c) defined by OPX, SEQ ID NO: 29, wherein said morphogen stimulates endochondral bone formation in an in vivo bone assay. 2. The method of claim 1 wherein said loss of bone mass results from a metabolic bone disease. 3. The method of claim 2 wherein said metabolic bone disease comprises osteoporosis or osteomalacia. 4. The method of claim 1 wherein said loss of bone mass results from an imbalance in bone resorption or bone formation. 5. The method of claim 1 wherein said loss of bone mass results from an imbalance of calcium or phosphate metabolism. 6. The method of claim 1 wherein said loss of bone mass results from a vitamin D imbalance in the individual. 7. The method of claim 1 wherein said loss of bone mass is nutritionally or hormonally induced. 8. The method of claim 3 wherein said osteoporosis is postmenopausal or senile osteoporosis. 9. The method of claim 1 wherein said morphogen comprises an amino acid sequence sharing at least 70% homology with one of the sequences selected from the group consisting of: OP-1, OP-2, CBMP2, Vgl(fx), Vgr(fx), DPP(fx), GDF-1(fx) and 60A(fx). 10. The method of claim 1 wherein said morphogen comprises an amino acid sequence sharing at least 80% homology with one of the sequences selected from the group consisting of: OP-1, OP-2, CBMP2, Vgl(fx), Vgr(fx), DPP(fx), GDF-1(fx), and 60A(fx). 11. The method of claim 1 wherein said morphogen comprises an amino acid sequence having greater than 60% amino acid identity with the sequence defined by residues 43-139 of Seq. ID No. 5 (hOP1). 12. The method of claim 1 wherein said morphogen comprises an amino acid sequence having greater than 65% amino acid identity with the sequence defined by residues 43-139 of Seq. ID No. 5 (hOP1). 13. The method of claim 1 wherein said morphogen comprises an amino acid sequence defined by residues 43-139 of Seq. ID No. 5 (hOP1), including allelic and species variants thereof. 14. The method of claim 1 wherein said morphogen comprises an amino acid sequence defined by Generic Sequences 1, 2, 3, 4, 5 or 6 (Seq. ID Nos. 1, 2, 3, 4, 30 or 31). 15. The method of claim 1 wherein said morphogen comprises an amino acid sequence defined by OPX (Seq. ID No. 29). 16. A method for repairing defects in bone tissue microstructure, comprising: systemically administering to an individual a therapeutically effective morphogen in an amount and for a time sufficient to repair defects in said microstructure, wherein the morphogen comprises an amino acid sequence selected from the group consisting of a sequence: (a) having at least 70% homology with the C-terminal seven-cysteine skeleton of human OP-1 as set forth in residues 330-431 of SEQ ID NO: 5; (b) having greater than 60% amino acid sequence identity with said C-terminal seven-cysteine skeleton of human OP-1; and (c) defined by OPX, SEQ ID NO: 29, wherein said morphogen stimulates endochondral bone formation in an in vivo bone assay. 17. The method of claim 16 wherein said defect is a fracture. 18. The method of claim 16 wherein said defect results from a metabolic bone disease. 19. The method of claim 18 wherein said metabolic bone disease comprises osteoporosis or osteomalacia. 20. A method for protecting an individual at risk for loss of bone mass, the method comprising: systemically administering to the individual a therapeutically effective morphogen in an amount and for a time sufficient to protect said individual from loss of bone mass, wherein the morphogen comprises an amino acid sequence selected from the group consisting of a sequence: (a) having at least 70% homology with the C-terminal seven-cysteine skeleton of human OP-1 as set forth in residues 330-431 of SEQ ID NO: 5; (b) having greater than 60% amino acid sequence identity with said C-terminal seven-cysteine skeleton of human OP-1; and (c) defined by OPX, SEQ ID NO: 29, wherein said morphogen stimulates endochondral bone formation in an in vivo bone assay. 21. The method of claim 20 wherein said individual is a postmenopausal female. 22. The method of claim 20 wherein said individual is at risk for loss of bone mass as a result of senile osteoporosis. 23. The method of claim 20 wherein said individual is undergoing dialysis. 24. The method of claim 16 or 20 wherein said morphogen comprises an amino acid sequence sharing at least 70% homology with one of the sequences selected from the group consisting of: OP-1, OP-2, CBMP2, Vgl(fx), Vgr(fx), DPP(fx), GDF-1(fx) and 60A(fx). 25. The method of claim 16 or 20 wherein said morphogen comprises an amino acid sequence sharing at least 80% homology with one of the sequences selected from the group consisting of: OP-1, OP-2, CBMP2, Vgl(fx), Vgr(fx), DPP(fx), GDF-1(fx), and 60A(fx). 26. The method of claim 16 or 20 wherein said morphogen comprises an amino acid sequence having greater than 60% amino acid identity with the sequence defined by residues 43-139 of Seq. ID No. 5 (hOP1). 27. The method of claim 16 or 20 wherein said morphogen comprises an amino acid sequence having greater than 65% amino acid identity with the sequence defined by residues 43-139 of Seq. ID No. 5 (hOP1). 28. The method of claim 16 or 20 wherein said morphogen comprises an amino acid sequence defined by residues 43-139 of Seq. ID No. 5 (hOP1), including allelic and species variants thereof. 29. The method of claim 16 or 20 wherein said morphogen comprises an amino acid sequence defined by Generic Sequences 1, 2, 3, 4, 5 or 6 (Seq. ID Nos. 1, 2, 3, 4, 30 or 31). 30. The method of claim 16 or 20 wherein said morphogen comprises an amino acid sequence defined by OPX (Seq. ID No. 29). 31. The method of claim 1, 16 or 20, wherein said morphogen or said morphogen-stimulating agent is provided to the individual by oral administration. 32. The method of claim 1, 16 or 20, wherein said morphogen or morphogen-stimulating agent is provided to the individual by parenteral administration. 33. The method of claim 1 or 20 wherein said morphogen is provided to said individual in association with a molecule capable of enhancing the solubility of said morphogen. 34. The method of claim 33 wherein said molecule comprises casein or part or all of the pro domain of a morphogen. 35. The method of claim 34 wherein said pro domain comprises part or all of the sequence described by residues 30 to 292 of Seq. ID No. 16. 36. The method of claim 1, 16, or 20 wherein said morphogen is provide to the individual in association with a molecule capable of targeting said morphogen to bone tissue. 37. The method of claim 36 wherein said targeting molecule comprises tetracycline, diphosphonates, or an antibody that binds specifically to a molecule on the surface of bone tissue cells. 38. The method of claim 1 or 20 wherein the morphogen is administered parenterally. 39. The method of claim 1 or 20 wherein the morphogen is administered orally. 40. The method of claim 1 or 20 further comprising administering vitamin D3, calcitonin, prostaglandins, parathyroid hormone, dexamethasone, estrogen or insulin-like growth factor (IGF) to the subject.

Details for Patent 7,056,882

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2011-03-11