Prevention and treatment of benign prostatic hyperplasia

Abstract

A method for treatment or prophylaxis of benign prostatic hyperplasia by administration of lonidamine or a lonidamine analog is provided. Also provided are unit dosage forms of lonidamine or an analog, useful for such treatment and prophylaxis.

1 . A method for treating or preventing benign prostatic hypertrophy (BPH) comprising administering a therapeutically or prophylactically effective amount of lonidamine or a lonidamine analog to a human subject in need of such treatment or prevention.  
     
     
         2 . A method for reducing a symptom associated with BPH in a human subject not under treatment for cancer, comprising administering lonidamine or a lonidamine analog to the human subject.  
     
     
         3 . A method for prophylaxis of BPH comprising administering a prophylactically effective amount lonidamine or a lonidamine analog to a human subject.  
     
     
         4 . The method of claims  2  or  claim 3  comprising administering a therapeutically effective amount of lonidamine.  
     
     
         5 . The method of any of  claims 1  to  3  comprising administering a therapeutically effective amount of a lonidamine analog.  
     
     
         6 . The method of  claim 5  comprising administering a therapeutically effective amount of tolnidamine, AF2364 or AF2785.  
     
     
         7 . The method of any of  claim 1  or  claim 3  wherein the subject is not diagnosed with, or under treatment for cancer.  
     
     
         8 . The method of any of  claims 1  to  3  wherein the subject has a serum PSA between 2 ng/ml and 10 ng/ml.  
     
     
         9 . The method of  claim 1  or  claim 2  wherein said lonidamine or lonidamine analog is administered in combination with another treatment for BPH, wherein said other treatment is 
 a) a surgical procedure;    b) laser therapy;    c) transurethral microwave thermotherapy;    d) balloon dilatation;    e) placement of a prostatic urethral stent;    f) transurethral needle ablation;    g) transurethral electrovaporization of the prostate;    h) administration of an alpha-blocker;    i) administration of a 5-alpha-reductase inhibitor; or,    j) administration of a glycolytic inhibitor.    
     
     
         10 . The method of any of claims  1 - 3 , wherein said lonidamine or lonidamine analog is administered 
 a) at least once daily for at least five days;    b) at least once daily for at least five days per week for at least three weeks per month for at least one month;    c) at least 10 days in a 15 day period; or    d) at least once per week for at least 4 weeks    
     
     
         11 . The method of any of claims  1 - 3 , wherein said treatment or prophylaxis comprises administering lonidamine or a lonidamine analog 
 a) less frequently than once per day;    b) on a one-time basis;    c) once-a-week;    d) once every two weeks; or    e) once-a-month.    
     
     
         12 . The method of any of claims  1 - 3  wherein the dose of lonidamine or a lonidamine analog administered in one day is 
 a) from 1 mg to 300 mg per administration;    b) from 300 mg to 500 mg per administration; or    c) from 500 mg to 5000 mg per administration.    
     
     
         13 . The method of any of claims  1 - 3  wherein the lonidamine or lonidamine analog is orally, administered parenterally, by inhalation spray, transdermally, rectally or by intraprostatic injection.  
     
     
         14 . A method for treating BPH comprising (a) diagnosing BPH in a patient, (b) administering lonidamine or a lonidamine analog to the patient and (c) determining whether one or more manifestations of BPH are reduced in said patient.  
     
     
         15 . A method for treating BPH comprising (a) administering lonidamine or a lonidamine analog to a patient diagnosed with BPH and (b) determining whether one or more manifestations of BPH are reduced in said patient.  
     
     
         16 . A unit dose oral pharmaceutical composition comprising lonidamine or a lonidamine analog.  
     
     
         17 . The method of  claim 5 , wherein lonidamine is administered as a unit dose oral pharmaceutical composition that is a sustained-release formulation comprising from about 1 mg to about 2000 mg lonidamine.  
     
     
         18 . A method comprising (a) advertising the use of lonidamine for treatment of BPH, and (b) selling lonidamine to individuals for use for treatment of BPH.