ERYTHROPOIETIN RECEPTOR PEPTIDE FORMULATIONS AND USES

• US 20090118183A1
• Filed: 07/23/2008
• Published: 05/07/2009
• Est. Priority Date: 06/03/2005
• Status: Active Grant

• Current Assignee: Affymax Incorporated
• Original Assignee: Affymax Incorporated
• Inventors: Woodburn, Kathryn Wynne, Duliege, Anne-Marie, Stead, Richard, Leuther, Kerstin, Naso, Robert Barnett
• Granted Patent: US 8,324,159 B2
• Time in Patent Office: Days
• US Class Current: 514/1.100
• CPC Class Codes: A61K 38/16 Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof enzyme inhibitors A61K38/005
• CPC Class Codes: C07K 17/08 the carrier being a synthetic polymer

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.

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 to the patient a therapeutically effective amount of a compound according to Formula I that binds to and activates the erythropoietin receptor (EPO-R), wherein the therapeutically effective amount is a dosage of 0.025 to 0.5 milligram of the compound per 1 kilogram of body weight of the patient

3. The method of claim 1, wherein the method further comprises a pharmaceutically acceptable carrier.

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

5. The method of claim 4, 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.

6. The method of claim 5, wherein the dosage is 0.05 to 0.1 milligram of the compound per 1 kilogram of body weight of the patient.

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

8. The method of claim 7, 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.

9. The method of claim 8, wherein the dosage is 0.2 to 0.4 milligram of the compound per 1 kilogram of body weight of the patient.

10. The method of claim 1, wherein the therapeutically effective amount is administered once every 3 to 4 weeks.

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

12. The method of claim 11, wherein the therapeutically effective amount is a dosage of 0.25 to 1.25 milligram of the compound per 1 kilogram of body weight of the patient.

13. The method of claim 12, wherein the dosage is 0.5 to 0.75 milligram of the compound per 1 kilogram of body weight of the patient.

14. The method of claim 11, wherein the therapeutically effective amount is administered once every 3 to 6 weeks.

15. The method of claim 14, wherein the therapeutically effective amount is administered once every 4 weeks.

16. The method of claim 11, wherein the therapeutically effective amount is administered by either intravenous or subcutaneous injection.

17. The method of claim 16, wherein the therapeutically effective amount is administered by subcutaneous injection.

18. The method of claim 7, 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.

19. The method of claim 7, wherein the malignancy is solid tumor malignancy or lymphoma.

2. The method according to claim 2 wherein the compound is Formula Ia