Erythropoitein 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.

What is claimed is: 
     
         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 
       
         
           
           
               
               
           
         
         wherein PEG is a polyethylene glycol moiety having a molecular weight of about 20,000 to about 50,000 Daltons. 
       
     
     
         2 . The method according to  claim 2  wherein the compound is Formula Ia 
       
         
           
           
               
               
           
         
       
     
     
         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.