Methods of treating a subject with benign prostate hyperplasia

Abstract

The invention generally relates to methods of treating a male subject with a prostate condition, for example, benign prostate hyperplasia (BPH). In certain embodiments, the invention provides methods of treating a male subject with a prostate condition, which include administering a MetAP2 inhibitor at a dose that does not substantially modulate angiogenesis.

What is claimed is: 
     
         1 . A method for treating benign prostatic hypertrophy (BPH) in a male subject in need thereof, comprising administering a therapeutically effective amount of a MetAP-2 inhibitor to said male subject. 
     
     
         2 . The method of  claim 1 , wherein the MetAP-2 inhibitor is a fumagillin-based compound. 
     
     
         3 . The method of  claim 1 , wherein the method results in a reduction in the rate of growth of the subject's prostate. 
     
     
         4 . The method of  claim 1 , wherein upon administration, the prostate of said male subject decreases by at least 25% within 30 days. 
     
     
         5 . The method of  claim 1 , wherein administration occurs parenterally. 
     
     
         6 . The method of  claim 1 , wherein administration is intravenous or subcutaneous. 
     
     
         7 . The method of  claim 1 , wherein at least one of sperm viability, motility, quantity, and rate of production are not substantially decreased after administration of said MetAP-2 inhibitor. 
     
     
         8 . The method of  claim 1 , further comprising administering an additional therapeutic agent. 
     
     
         9 . The method of  claim 8 , wherein the additional therapeutic agent is selected from the group consisting of an alpha blocker, a 5 alpha reductase inhibitor, saw palmetto, beta-sitosterol, and pygeum. 
     
     
         10 . The method of  claim 9 , wherein the alpha blocker is selected from the group consisting of terazosin, doxazosin, tamsulosin and alfuzosin. 
     
     
         11 . The method of  claim 9 , wherein the 5 alpha reductase inhibitor is selected from the group consisting of finasteride and dutasteride. 
     
     
         12 . The method of  claim 1 , further comprising administering a non-invasive procedure. 
     
     
         13 . The method of  claim 12 , wherein the non-invasive procedure is selected from the group consisting of transurethral microwave therapy (TUMT), transurethral needle ablation (TUNA), interstitial laser therapy (ILT), and prostatic stents. 
     
     
         14 . The method of  claim 1 , further comprising administering a surgical treatment. 
     
     
         15 . The method of  claim 14 , wherein the surgical treatment is selected from the group consisting of transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), laser surgery, and open prostatectomy. 
     
     
         16 . The method of  claim 1 , wherein the MetAP-2 inhibitor is a Compound I, represented by: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         17 . The method of  claim 1 , wherein the MetAP- 2  inhibitor is administered at a dose of about 0.01 mg/kg to about 10 mg/kg. 
     
     
         18 . The method of  claim 1 , wherein the MetAP-2 inhibitor is administered at a dose of about 0.04 mg/kg to about 1.0 mg/kg. 
     
     
         19 . A method for reducing the prostate gland in a male subject in need thereof, comprising administering a therapeutically effective amount of a MetAP-2 inhibitor to a male subject in need thereof.