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1. (WO1993019085) NOUVEAUX FACTEURS DE CROISSANCE OSSEUSE DERIVE DE L'ANDOUILLER
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What is claimed as new and intended to be covered by letters patent of the United States is:

1. An isolated and purified biologically active proteinaceous material comprising polypeptides containing the amino acid sequence selected from the group consisting of M-A-G-L-G-D-E-F-G-D, [SEQ ID NO: 1], (X) F-E-T-L-F-G-AV-E-D-V-l/D-A-L, [SEQ ID NO: 22], and A-Y-l-P-l-E-T-L-E-G-l/G-E-L-V-D/Q-T-G/L-Q-F, [SEQ ID NO: 3], or biologically active polypeptide fragments or sequence analogues thereof.

2. The proteinaceous material of claim 1 , comprising a polypeptide substantially free of other proteins of deer origin.

3. The proteinaceous material of claim 1 comprising a polypeptide having a molecular weight of from about 6000 to about 8000 daltons.

4. The proteinaceous material of claim 1 wherein said polypeptide is OT-1.

5. The proteinaceous material of claim 1 wherein said polypeptide is OT-2.

6. The proteinaceous material of claim 1 wherein said polypeptide is OT-4.

7. The proteinaceous material of claim 1 which stimulates the proliferation of human C433 stromal cells and human MG-63 osteosarcoma cells.

8. The proteinaceous material according to claim 5 having a specific activity of at least about 51 U/mg protein.

9. The proteinaceous material according to claim 5 having a specifi activity of at least about 9.4 x 106 U/mg protein.

10. The proteinaceous material according to claim 6 having a specific activity of at least about 4 U/mg protein.

11. A process for purifying a proteinaceous material of claim 1 which comprises:
a. subjecting either an antler tissue extract or cultured deer
cell conditioned medium to affinity chromatography;
b. subjecting the biologically active fractions of step a to gel
permeation chromatography;
c. subjecting the biologically active fractions of step b to
reverse phase high pressure liquid chromatography; and
d. recovering said proteinaceous material in substantially pure form.

12. An isolated and purified biologically active polypeptide and biologically active fragments thereof comprising the amino acid sequence selected from the group consisting of M-A-G-L-G-D-E-F-G-D, [SEQ ID NO: 1], (X) F-E-T-L-F-G-A/V-E-D-V-l/D-A-L, [SEQ ID NO: 22], and A-Y-l-P-l-E-T-L-E-G-l/G-E-L-V-D/Q-T-G/L-Q-F, [SEQ ID NO: 3], purified by the method of claim 11.

13. A process according to claim 11 for purifying OT-4 comprising collecting conditioned medium from cultured deer antler cells.

14. OT-4 purified by the method of claim 11.

15. An antibody which binds to the proteinaceous material of claim 1.

16. The antibody of claim 15 wherein said antibody binds to an epitope of said proteinaceous material comprising a sequence selected from the group consisting of M-A-G-L-G-D-E-F-G-D, [SEQ ID NO: 1], (X) F-E-T-L-F-G-A V-E-D-V-l/D-A-L, [SEQ ID NO: 22], and A-Y-l-P-l-E-T-L-E-G-l/G-E-L-V-D/Q-T-G/L-Q-F, [SEQ ID NO: 3].

17. The antibody of claim 16 wherein said antibody binds to an epitope of OT-2.

18. The antibody of claim 16 wherein said antibody binds to an epitope of OT-4.

19. A method of treating osteoporosis in a human or other animal suffering therefrom comprising administering thereto an amount of the polypeptide of claim 1 effective to stimulate bone growth.

20. A method of treating osteopetrosis in a human or other animal comprising administering to an individual in need of said treatment an antibody which binds to the proteinaceous material of claim 1 in an amount effective to inhibit bone growth.

21. A pharmaceutical composition for the treatment of bone disorders comprising an effective bone cell stimulatory amount of a proteinaceous material of claim 1.

22. A pharmaceutical composition for the treatment of bone disorders comprising an effective bone cell growth inhibitory amount of an antibody according to claim 15.

23. A cDNA encoding deer IGF-II.