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Last Updated: December 23, 2024

Claims for Patent: 7,923,008


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Summary for Patent: 7,923,008
Title:Methods for decreasing osteoclast formation or bone resorption using an antibody to osteoprotegerin binding protein
Abstract: A novel polypeptide, osteoprotegerin binding protein, involved in osteolcast maturation has been identified based upon its affinity for osteoprotegerin. Nucleic acid sequences encoding the polypeptide, or a fragment, analog or derivative thereof, vectors and host cells for production, methods of preparing osteoprotegerin binding protein, and binding assays are also described. Compositions and methods for the treatment of bone diseases such as osteoporosis, bone loss due to arthritis or metastasis, hypercalcemia, and Paget\'s disease are also provided.
Inventor(s): Boyle; William J. (Moorpark, CA)
Assignee: Amgen Inc. (Thousand Oaks, CA)
Application Number:11/336,067
Patent Claims:1. A method of decreasing bone resorption comprising selecting a patient having an increase in the rate of bone resorption over the rate of bone formation, and administering to the patient a composition comprising a monoclonal antibody or binding fragment thereof which specifically binds to an osteoprotegerin binding protein consisting of amino acid residues 1 to 317 as shown in FIG. 4 (SEQ ID NO:39) wherein the monoclonal antibody or binding fragment thereof is an antagonist which decreases the activity of osteoprotegerin binding protein.

2. The method of Claim 1 wherein the antibody or binding fragment thereof is a recombinant antibody.

3. The method of claim 1 wherein the antibody or binding fragment thereof is a chimeric antibody or a CDR-grafted antibody.

4. The method of claim 1 wherein the antibody or binding fragment thereof is a human antibody.

5. The method of Claim 4 wherein the antibody or binding fragment thereof is prepared by immunization of a transgenic animal capable of producing human antibodies.

6. The method of Claim 1 wherein the antibody or binding fragment thereof specifically binds to an extracellular domain of an osteoprotegerin binding protein.

7. The method of claim 1 wherein the antibody or binding fragment thereof specifically binds to an osteoprotegerin binding protein consisting of amino acid residues 69 to 317 as shown in FIG. 4 (SEQ ID NO:39).

8. The method of Claim 1 wherein the antibody or binding fragment thereof specifically binds to an osteoprotegerin binding protein consisting of amino acid residues 158 to 317 as shown in FIG. 4 (SEQ ID NO:39).

9. The method of Claim 1 wherein the antibody or binding fragment thereof specifically binds to an osteoprotegerin binding protein consisting of amino acid residues 166 to 317 as shown in FIG. 4 (SEQ ID NO:39).

10. The method of claim 1 wherein the composition comprises a pharmaceutically acceptable diluent, carrier, solubilizer, emulsifier, preservative and/or adjuvant.

11. The method of claim 10 wherein the diluent is acetate buffer.

12. The method of claim 10 wherein the solubilizer is polysorbate.

13. The method of claim 1 further comprising administering one or more of a bone morphogenic factor, transforming growth factor-.beta., a transforming growth factor-.beta. family member, a fibroblast growth factor, an interleukin-1 inhibitor, a TNF.alpha. inhibitor, parathyroid hormone, an E series prostaglandin, a bisphosphonate, or a bone-enhancing mineral.

14. The method of claim 1 wherein the increase in bone resorption is associated with osteoporosis, osteomyelitis, hypercalcemia, osteopenia brought on by surgery or steroid administration, Paget's disease, osteonecrosis, bone loss due to rheumatoid arthritis, periodontal bone loss, osteopenia due to immobilization, prosthetic loosening or osteolytic metastasis.

15. The method of claim 1 wherein the antibody or binding fragment thereof specifically binds to a membrane associated form of osteoprotegerin binding protein.

16. The method of claim 1 wherein the antibody or binding fragment thereof specifically binds to a soluble osteoprotegerin binding protein.

17. A method of decreasing osteoclast formation comprising selecting a patient having an increase in the rate of bone resorption over the rate of bone formation, and administering to the patient a composition comprising a monoclonal antibody or binding fragment thereof which specifically binds to an osteoprotegerin binding protein consisting of amino acid residues 1 to 317 as shown in FIG. 4 (SEQ ID NO:39), wherein the monoclonal antibody or binding fragment thereof is an antagonist which decreases the activity of osteoprotegerin binding protein.

18. The method of claim 17 wherein the antibody or binding fragment thereof is a recombinant antibody.

19. The method of claim 17 wherein the antibody or binding fragment thereof is a chimeric antibody or a CDR-grafted antibody.

20. The method of claim 17 wherein the antibody or binding fragment thereof is a human antibody.

21. The method of claim 20 wherein the antibody or binding fragment thereof is prepared by immunization of a transgenic animal capable of producing human antibodies.

22. The method of claim 17 wherein the antibody or binding fragment thereof specifically binds to an extracellular domain of an osteoprotegerin binding protein.

23. The method of claim 17 wherein the antibody or binding fragment thereof specifically binds to an osteoprotegerin binding protein consisting of amino acid residues 69 to 317 as shown in FIG. 4 (SEQ ID NO:39).

24. The method of claim 17 wherein the antibody or binding fragment thereof specifically binds to an osteoprotegerin binding protein consisting of amino acid residues 158 to 317 as shown in FIG. 4 (SEQ ID NO:39).

25. The method of claim 17 wherein the antibody or binding fragment thereof specifically binds to an osteoprotegerin binding protein consisting of amino acid residues 166 to 317 as shown in FIG. 4 (SEQ ID NO:39).

26. The method of claim 17 wherein the composition comprises a pharmaceutically acceptable diluent, carrier, solubilizer, emulsifier, preservative and/or adjuvant.

27. The method of claim 17 wherein the diluent is acetate buffer.

28. The method of claim 26 wherein the solubilizer is polysorbate.

29. The method of any of claim 17 further comprising administering one or more of a bone morphogenic factor, transforming growth factor-.beta., a transforming growth factor-.beta. family member, a fibroblast growth factor, an interleukin-1 inhibitor, a TNF.alpha. inhibitor, parathyroid hormone, an E series prostaglandin, a bisphosphonate, or a bone-enhancing mineral.

30. The method of claim 17 wherein the increase in bone resorption is associated with osteoporosis, osteomyelitis, hypercalcemia, osteopenia brought on by surgery or steroid administration, Paget's disease, osteonecrosis, bone loss due to rheumatoid arthritis, periodontal bone loss, osteopenia due to immobilization, prosthetic loosening and osteolytic metastasis.

31. The method of claim 17 wherein the antibody or binding fragment thereof specifically binds to a membrane associated form of osteoprotegerin binding protein.

32. The method of claim 17 wherein the antibody or binding fragment thereof specifically binds to a soluble osteoprotegerin binding protein.

33. The method of claim 17 wherein the antibody or binding fragment thereof is raised against an osteoprotegerin binding protein comprising the amino acid sequence as shown in FIG. 4 (SEQ ID NO:39) from residues 1-317, or an immunogenic fragment thereof.

34. The method of claim 17 wherein the antibody or binding fragment thereof is raised against an osteoprotegerin binding protein comprising the amino acid sequence as shown in FIG. 4 (SEQ ID NO:39) from residues 69-317.

Details for Patent 7,923,008

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. PROLIA denosumab Injection 125320 June 01, 2010 ⤷  Subscribe 2017-04-16
Amgen Inc. XGEVA denosumab Injection 125320 November 18, 2010 ⤷  Subscribe 2017-04-16
Takeda Pharmaceuticals U.s.a., Inc. NATPARA parathyroid hormone For Injection 125511 January 23, 2015 ⤷  Subscribe 2017-04-16
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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