Collagenase Clostridium for Treating Esophageal Ailments

Abstract

Collagenase Clostridium Histolyticum (EN3835) is a proteinase that can hydrolyze the triple-helical region of collagen under physiological conditions. EN3835 targets the collagenase structural matrix at the site of injection and does not require systemic exposure. Embodiments include methods of lysing subdermal and submucosal collagen to treat various conditions such as bladder dysfunction, esophageal stenosis, benign prostatic hyperplasia, tracheal stenosis, subglottic stenosis and scleroderma.

What is claimed is: 
     
         1 . A method of reducing localized collagen tissue in a patient in need thereof comprising injection of an effective amount of collagenase  Clostridium histolyticum  at or near the localized collagen tissue,
 wherein the localized collagen tissue is esophageal stricture, and   wherein the injection comprises multiple injections at a plurality of sites at or near the esophageal stricture, each injection of a volume of about 0.2 ml or less.   
     
     
         2 . The method of  claim 1 , wherein the localized collagen tissue is scar tissue. 
     
     
         3 . The method of  claim 1 , wherein the localized collagen tissue is formed from an autoimmune disease. 
     
     
         4 . The method of  claim 3 , including a wherein the autoimmune disease is scleroderma. 
     
     
         5 . The method of  claim 1 , wherein a total of 0.01 mg to 0.5 mg of collagenase  Clostridium histolyticum  in solution is injected. 
     
     
         6 . The method of  claim 1 , wherein a total of 0.02 mg to 0.05 mg of collagenase  Clostridium histolyticum  in solution is injected. 
     
     
         7 . The method of  claim 1 , including an additional step of endoscopic dilation. 
     
     
         8 . The method of  claim 1 , wherein the collagenase  Clostridium histolyticum  is comprised of equal amounts of Clostridial class I collagenase (AUX-I) and Clostridial class II collagenase (AUX-II). 
     
     
         9 . The method of  claim 1 , wherein the collagenase  clostridium  is injected using a syringe with a rack and pinion component. 
     
     
         10 . A method of treating esophageal stricture in a patient in need thereof comprising steps of:
 a) identifying a patient with signs and/or symptoms of esophageal stricture,   b) injecting an effective amount of collagenase  Clostridium histolyticum  at a first plurality of sites at or near the esophageal stricture,   c) monitoring signs and/or symptoms of esophageal stricture,   d) injecting an effective amount of collagenase  Clostridium histolyticum  at a second plurality of sites at or near the esophageal stricture, and   e) repeating steps c) and d) until the signs and/or symptoms of esophageal stricture subside,   wherein each injection has a volume of about 0.2 ml or less.   
     
     
         11 . The method of  claim 10 , including the esophageal stricture caused by scleroderma. 
     
     
         12 . The method of  claim 10 , wherein a total of 0.01 mg to 0.5 mg of collagenase  Clostridium histolyticum  in solution is injected. 
     
     
         13 . The method of  claim 10 , wherein a total of 0.02 mg to 0.05 mg of collagenase  Clostridium histolyticum  in solution is injected. 
     
     
         14 . The method of  claim 10 , including an additional step of endoscopic dilation. 
     
     
         15 . The method of  claim 10 , wherein the collagenase  Clostridium histolyticum  is comprised of equal amounts of Clostridial class I collagenase (AUX-I) and Clostridial class II collagenase (AUX-II). 
     
     
         16 . The method of  claim 10 , wherein the collagenase  clostridium  is injected using a syringe with a rack and pinion component.