Treatment Method and Product for Uterine Fibroids using Purified Collagenase

Abstract

The invention relates to compositions and methods for treating uterine fibroids, wherein a uterine fibroid treatment agent comprising collagenase in an amount effective to cause shrinkage of uterine fibroids is injected or inserted into the uterine fibroid.

1 . A composition for treating a uterine fibroid in a patient, comprising an amount of  Clostridium histolyticum  collagenase effective to treat said uterine fibroid by injection through a uterine fibroid capsule into said uterine fibroid in the patient, wherein said collagenase is obtained by separately purifying  Clostridium histolyticum  collagenase I and collagenase II and recombining said collagenase I and collagenase II in an optimized fixed mass ratio. 
     
     
         2 . The composition of  claim 1 , wherein said composition can be administered through a syringe fitted with a 10 gauge or smaller needle. 
     
     
         3 . A kit for providing at least one therapeutic dose of a formulation of  claim 1 , said kit comprising in a unit package at least one container containing a sterile thermosensitive hydrogel fluid in an amount sufficient for at least one therapeutic dose; and at least one second container containing an effective amount of collagenase in lyophilized, powder form. 
     
     
         4 . The composition of  claim 1 , wherein said composition further comprises a chemical ablation agent, a non-steroidal anti-inflammatory drug, an oral contraceptive, a GnRH agonist, an antiprogestogen, or a selective progesterone receptor modulator. 
     
     
         5 . The composition of  claim 4 , wherein said composition further comprises a chemical ablation agent. 
     
     
         6 . The composition of  claim 5 , wherein said chemical ablation agent is a salt. 
     
     
         7 . The composition of  claim 6 , wherein said chemical ablation agent is selected from an enzyme, an acid, a base and an oxidizing agent. 
     
     
         8 . The composition of  claim 1 , wherein said composition further comprises one or more uterine fibroid treatment agents. 
     
     
         9 . The composition of  claim 1 , wherein said composition comprises 0.25 mg/mL collagenase from  Clostridium histolyticum.    
     
     
         10 . The composition of  claim 1 , wherein said composition comprises 0.5 mg/mL collagenase from  Clostridium histolyticum.    
     
     
         11 . The composition of  claim 1 , wherein said composition comprises 1.0 mg/mL collagenase from  Clostridium histolyticum.    
     
     
         12 . The composition of  claim 1 , wherein said composition comprises 2.0 mg/mL collagenase from  Clostridium histolyticum.    
     
     
         13 . The composition of  claim 1 , wherein said composition comprises collagenase I and collagenase II in a mass ratio of about 0.5:1.5. 
     
     
         14 . The composition of  claim 1 , wherein said composition comprises collagenase I and collagenase II in a mass ratio of about 0.6:1.3. 
     
     
         15 . The composition of  claim 1 , wherein said composition comprises collagenase I and collagenase II in a mass ratio of about 0.8:1.2.