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Details for Patent: 8,324,159

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Details for Patent: 8,324,159

Title:Erythropoietin receptor peptide formulations and uses
Abstract: The present invention relates to peptide compounds that are agonists of the erythropoietin receptor (EPO-R). The invention also relates to therapeutic methods using such peptide compounds to treat disorders associated with insufficient or defective red blood cell production. Pharmaceutical compositions, which comprise the peptide compounds of the invention, and dosages are also provided.
Inventor(s): Duliege; Anne-Marie (Palo Alto, CA), Stead; Richard (Bellevue, WA), Leuther; Kerstin (San Jose, CA), Woodburn; Kathryn Wynne (Saratoga, CA), Naso; Robert Barnett (Menlo Park, CA)
Assignee: Affymax, Inc. (Palo Alto, CA)
Filing Date:Jul 23, 2008
Application Number:12/178,583
Claims:1. A method for treating a patient having a disorder characterized by a deficiency of erythropoietin or a low or defective red blood cell population, which method comprises administering once every 3-4 weeks to the patient a therapeutically effective amount of a compound that binds to and activates an erythropoietin receptor (EPO-R), wherein the compound comprises: (a) a first peptide monomer and a second peptide monomer, each of said first and second peptide monomers comprising the amino acid sequence (AcG)GLYACHMGPIT(1-nal)VCQPLR (SEQ ID NO:14); (b) a linker moiety covalently bonding the first peptide monomer to the second peptide monomer; and (c) a spacer moiety covalently joining the linker moiety and a poly(ethylene glycol) (PEG) moiety, said PEG moiety comprising a linear, unbranched PEG having a molecular weight of 10,000 to 60,000 Daltons.

2. The method of claim 1, wherein the compound is administered with a pharmaceutically acceptable carrier.

3. The method of claim 1, wherein the disorder is renal failure or dialysis.

4. The method of claim 1, wherein the disorder is anemia associated with a malignancy.

5. The method of claim 1, wherein the disorder is chronic kidney disease.

6. The method of claim 5, wherein the therapeutically effective amount is a dosage of 0.25 to 0.5 milligram of the compound per 1 kilogram of body weight of the patient.

7. The method of claim 1, wherein the dosage is 0.5 to 0.75 milligram of the compound per 1 kilogram of body weight of the patient.

8. The method of claim 1, wherein the therapeutically effective amount is administered once every 4 weeks.

9. The method of claim 1, wherein the therapeutically effective amount is administered by intravenous injection.

10. The method of claim 1, wherein the therapeutically effective amount is administered by subcutaneous injection.

11. The method of claim 4, wherein the therapeutically effective amount is a dosage of 0.05 to 0.5 milligram of the compound per 1 kilogram of body weight of the patient.

12. The method of claim 4, wherein the malignancy is solid tumor malignancy or lymphoma.

13. The method of claim 12, wherein the malignancy is a solid tumor malignancy selected from the group consisting of breast cancer, lung cancer and prostate cancer.

14. The method of claim 4 wherein the patient is undergoing chemotherapy.

15. The method of claim 14, wherein the compound is co-administered with the chemotherapy.

16. The method of claim 14, wherein the compound is administered prior to the chemotherapy.

17. The method of claim 16, wherein the compound is administered 3-5 days before the chemotherapy.

18. The method of claim 1, wherein the amino acid sequence additionally comprises (MeG), K or (MeG)K.

19. The method of claim 18, wherein the amino acid sequence is: (AcG)GLYACHMGPIT(1-nal)VCQPLRK (SEQ ID NO:1).

20. The method of claim 18, wherein the amino acid sequence is: (AcG)GLYACHMGPIT(1-nal)VCQPLR(MeG) (SEQ ID ON:3).

21. The method of claim 18, wherein the amino acid sequence is: (AcG)GLYACHMGPIT(1-nal)VCQPLR(MeG)K (SEQ ID NO:2).

22. The method of claim 1, wherein the spacer moiety is an iminodiacetic moiety.

23. The method of claim 1, wherein the spacer moiety has the formula: ##STR00101## wherein R.sub.4 is selected from the group consisting of NHCO, CO, COO and NHCOO.

24. The method of claim 1, wherein the linker moiety is lysine.

25. The method of claim 1, wherein the PEG moiety has a molecular weight of 10,000 to 50,000 Daltons.

26. The method of claim 25, wherein the PEG moiety has a molecular weight of 20,000 to 40,000 Daltons.

27. A method for treating a patient having a disorder characterized by a deficiency of erythropoietin or a low or defective red blood cell population, which method comprises administering once every 3-4 weeks to the patient a therapeutically effective amount of a compound according to Formula I: ##STR00102## wherein PEG.sub.20k-50k is a polyethylene glycol moiety having a molecular weight of about 20,000 to about 50,000 Daltons.

28. A method for treating a patient having a disorder characterized by a deficiency of erythropoietin or a low or defective red blood cell population, which method comprises administering once every 3-4 weeks to the patient a therapeutically effective amount of a compound according to Formula IA: ##STR00103## whereinPEG.sub.20k is a polyethylene glycol moiety having a molecular weight of about 20,000 Daltons.

29. The method of claim 27 or 28, wherein the disorder is anemia associated with a malignancy.

30. The method of claim 29, wherein the malignancy is a solid tumor malignancy selected from the group consisting of breast cancer, lung cancer and prostate cancer.

31. The method of claim 29, wherein the patient is undergoing chemotherapy.

32. The method of claim 31, wherein the compound is co-administered with the chemotherapy.

33. The method of claim 31, wherein the compound is administered prior to the chemotherapy.

34. The method of claim 33, wherein the compound is administered 3-5 days before the chemotherapy.

35. The method of claim 29, wherein the therapeutically effective amount is a dosage of 0.075 to 0.5 milligram of the compound per 1 kilogram of body weight of the patient.

36. The method of claim 35, wherein the dosage is 0.2 to 0.4 milligram of the compound per 1 kilogram of body weight of the patient.

37. The method of claim 27 or 28, wherein the disorder is renal failure or dialysis.

38. The method of claim 37, wherein the therapeutically effective amount is a dosage of 0.025 to 0.2 milligram of the compound per 1 kilogram of body weight of the patient.

39. The method of claim 38, wherein the dosage is 0.05 to 0.1 milligram of the compound per 1 kilogram of body weight of the patient.
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