Claims for Patent: 8,299,046

Summary for Patent: 8,299,046

Title:	Synthetic triterpenoids and tricyclic-bis-enones for use in stimulating bone and cartilage growth
Abstract:	The present invention concerns methods for stimulating the growth and repair of bone and cartilage using synthetic triterpenoids and tricyclic-bis-enones. Examples of suitable triterpenoids include CDDO, CDDO-Me, CDDO-Im, and CDDO-Ethylamide. Examples of tricyclic-bis-enones include TBE-31 and TBE-34.
Inventor(s):	Sporn; Michael B. (Tunbridge, VT), Liby; Karen T. (West Lebanon, NH), Honda; Tadashi (Hanover, NH), Mundy; Gregory (San Antonio, TX), Garrett; Ross (Austin, TX), Reddi; Hari (El Macero, CA), Gribble; Gordon W. (Lebanon, NH), Niikura; Takahiro (Kobe, JP)
Assignee:	Trustees of Dartmouth College (Hanover, NH) Osteoscreen, Inc. (San Antonio, TX) The Regents of the Universtiy of California (Oakland, CA)
Application Number:	11/941,723
Patent Claims:	1. A method for stimulating a bone-forming or osteochondrogenic cell comprising: a) providing a bone-producing or osteochondrogenic cell; b) contacting said cell with an effective amount of a compound having the structure: ##STR00039## wherein Y is hydroxy, methoxy, ethyl-amino, or ##STR00040## a pharmaceutically acceptable salt or tautomer thereof; and c) culturing the cell. 2. The method of claim 1, wherein the cell is of human origin. 3. The method of claim 1, wherein the cell is of bovine, equine, canine, feline, murine, rat or chick origin. 4. The method of claim 1, further comprising incubating said cell with a growth factor. 5. The method of claim 4, wherein the growth factor is TGF-.beta.1, TGF-.beta.2, TGF-.beta.1.2, VEGF, insulin-like growth factor I or II, BMP2, BMP4, or BMP7. 6. The method of claim 4, wherein the growth factor is parathyroid hormone, calcitonin, interleukin-6, or interleukin-11. 7. The method of claim 1, further comprising purifying said cell after step (b). 8. The method of claim 1, further comprising implanting said cell in vivo after step (b) and/or step (c). 9. The method of claim 1, wherein bone is formed by said cell. 10. The method of claim 1, wherein the cell is an osteoblast. 11. A method of providing bone tissue to a mammal comprising: a) providing a bone-producing cell; b) contacting said cell with an effective amount of a compound having the structure: ##STR00041## wherein Y is hydroxy, methoxy, ethyl-amino, or ##STR00042## a pharmaceutically acceptable salt or tautomer thereof; c) culturing the cell to form bone; and d) implanting said bone to said subject. 12. The method of claim 11, wherein the bone formed in step (c) is part of a three-dimensional matrix. 13. The method of claim 12, wherein the three-dimensional matrix is one or more of alginate gels, collagen gels, or fibrin gels. 14. The method of claim 12, wherein the three-dimensional matrix comprises one or more of polylactic acid, polyglycolic acid or PGLA. 15. The method of claim 12, wherein the three-dimensional matrix comprises one or more of hydroxyapatite or other apatitic compounds, devitalized animal bone, devitalized human bone, or porous ceramic structures. 16. The method of claim 11, wherein the mammal has cancer bone disease, localized osteolysis due to cancer and to myeloma, degenerative cartilage conditions, osteoarthritis, osteoporosis, Vitamin D deficiency, Osteotitis deformans, or Von Recklinghausen's Disease. 17. The method of claim 11, wherein the cell is of human origin. 18. The method of claim 11, wherein the cell is of bovine, equine, canine, feline, murine, rat or chick origin. 19. A method for producing bone ex vivo comprising: a) providing a bone-producing cell; b) contacting said cell with an effective amount of a compound having the structure: ##STR00043## wherein Y is hydroxy, methoxy, ethyl-amino, or ##STR00044## a pharmaceutically acceptable salt or tautomer thereof; and c) culturing the cell to form bone. 20. A method of repairing bone damage in a patient having a bone defect, bone trauma, osteoarthritis, osteoporosis, or Vitamin D deficiency, comprising administering to said patient an amount of a compound effective to repair bone damage, said compound having the structure: ##STR00045## wherein Y is hydroxy, methoxy, ethyl-amino, or ##STR00046## a pharmaceutically acceptable salt or tautomer thereof. 21. A method for stimulating a cartilage-forming cell comprising: a) providing a cartilage-producing or osteochondrogenic cell; b) contacting said cell with an effective amount of a compound having the structure: ##STR00047## or a pharmaceutically acceptable salt or tautomer thereof; and c) culturing the cell. 22. A method of repairing cartilage damage in a patient having cartilage disease or cartilage trauma comprising administering to said patient an amount of a compound effective to repair cartilage damage, said compound having the structure: ##STR00048## or a pharmaceutically acceptable salt or tautomer thereof. 23. The method of claim 22, wherein the patient is human. 24. The method of claim 22, wherein cartilage is formed. 25. The method of claim 20, wherein the compound is administered to a wound. 26. The method of claim 20, wherein the compound is administered to a bone disease site. 27. The method of claim 20, wherein the patient has bone trauma. 28. The method of claim 20, wherein the patient has a bone defect. 29. The method of claim 28, wherein the bone defect is the result of a birth defect. 30. The method of claim 20, wherein the patient is human. 31. The method of claim 20, wherein bone is formed. 32. The method of claim 27, wherein the bone trauma is a fracture. 33. The method of claim 28, wherein the bone defect is the result of cancer surgery. 34. The method of claim 20, wherein the patient has osteoarthritis. 35. The method of claim 20, wherein the patient has osteoporosis. 36. The method of claim 20, wherein the patient has Vitamin D deficiency.

Details for Patent 8,299,046

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2026-11-17