Gossypol co-crystals and the use thereof

Abstract

This invention relates to compositions comprising co-crystals of (−)-gossypol with a C 1-8 carboxylic acid or C 1-8 sulfonic acid which are useful as inhibitors of Bcl-2 family proteins. The invention also relates to the use of co-crystals of (−)-gossypol with a C 1-8 carboxylic acid or C 1-8 sulfonic acid for inducing apoptosis in cells and for sensitizing cells to the induction of apoptotic cell death.

1 .- 28 . (canceled) 
   
   
       29 . A composition comprising co-crystals of (−)-gossypol with acetic acid. 
   
   
       30 . The composition of  claim 29 , wherein said composition consists essentially of co-crystals of (−)-gossypol with acetic acid. 
   
   
       31 . A method of treating a hyperproliferative disease or cancer in an animal, comprising administering to said animal a therapeutically effective amount of a pharmaceutical composition comprising the composition of  claim 29  and a pharmaceutically acceptable carrier. 
   
   
       32 . The method of  claim 31 , further comprising administering to said animal an inducer of apoptosis. 
   
   
       33 . The method of  claim 32 , wherein said inducer of apoptosis is a chemotherapeutic agent. 
   
   
       34 . The method of  claim 32 , wherein said inducer of apoptosis is radiation. 
   
   
       35 . The method of  claim 32 , wherein said composition is administered prior to said inducer of apoptosis. 
   
   
       36 . The method of  claim 32 , wherein said composition is administered concurrently with said inducer of apoptosis. 
   
   
       37 . The method of  claim 32 , wherein said composition is administered after said inducer of apoptosis. 
   
   
       38 . A method of treating a viral, microbial, or parasitic infection in an animal, comprising administering to said animal a therapeutically effective amount of a pharmaceutical composition comprising the composition of  claim 29  and a pharmaceutically acceptable carrier. 
   
   
       39 . A method of treating, ameliorating, or preventing a disorder responsive to the induction of apoptosis in an animal, comprising administering to said animal a therapeutically effective amount of a pharmaceutical composition comprising the composition of  claim 29  and a pharmaceutically acceptable carrier. 
   
   
       40 . The method of  claim 39 , further comprising administering to said animal an inducer of apoptosis. 
   
   
       41 . A kit comprising the composition of  claim 29  and instructions for administering said composition to an animal. 
   
   
       42 . The kit of  claim 41 , wherein said composition is in the form of a pharmaceutical composition comprising a pharmaceutically acceptable carrier. 
   
   
       43 . The kit of  claim 41 , further comprising an inducer of apoptosis. 
   
   
       44 . The kit of  claim 43 , wherein said inducer of apoptosis is a chemotherapeutic agent. 
   
   
       45 . The kit of  claim 41 , wherein said instructions are for administering said composition to an animal having a hyperproliferative disease. 
   
   
       46 . The kit of  claim 45 , wherein said hyperproliferative disease is cancer.