The DispersinB is an antibiofilm enzyme that inhibits and disperses biofilms of major bacterial pathogens.
The document have been submitted in connection with the filing of investigational new drug application (NDA) with the FDA for conducting clinical studies and demonstrate the safety and preliminary effectiveness of DispersinB.
Kane Biotech president and CEO Gord Froehlich said this document provides the FDA with data and information on DispersinB for their review and comments and to determine if there is any additional information that they require for their review.
"DispersinB is a unique wound care product intended to assist in the healing of wounds by preventing or disrupting biofilm infections, and we are pleased to be able to provide our data package to the FDA," Froehlich said.
The DispersinB topical wound spray was manufactured by Therapure Biopharma, under current good manufacturing practices (cGMP).