Sep 28 2009
Kane Biotech Inc. (TSX VENTURE:KNE), a biotechnology company engaged in the development of products that prevent and remove microbial biofilms is pleased to announce that DispersinB® Topical Wound Gel has passed the FDA-recommended Cytotoxicity and Primary Skin Irritation tests conducted by WuXi AppTec Inc. (St. Paul, MN) in compliance with Good Laboratory Practice (GLP). Thus, DispersinB® wound gel is considered non-cytotoxic and non-irritant. The other FDA-recommended biocompatibility tests (sensitization, genotoxicity and sub-chronic toxicity) are currently in progress.
In addition, the University of Medicine and Dentistry of New Jersey has also studied the cytotoxicity of research grade DispersinB® enzyme under Non-GLP conditions.
"We have tested the in vitro cytotoxicity of DispersinB® enzyme using human and mouse cell lines and DispersinB® enzyme showed negligible or no cytotoxicity against the cultured cell lines under the conditions tested," stated Dr. Jeffrey B. Kaplan, the discoverer of the DispersinB enzyme and Associate Professor, Department of Oral Microbiology, University of Medicine and Dentistry of New Jersey, Newark, NJ. "The clinical grade DispersinB® cytotoxicity test results from WuXi AppTec confirm our findings that DispersinB® is non-cytotoxic," concluded Dr. Kaplan.
"Although DispersinB® is a naturally occurring enzyme produced by one of the oral bacteria, it is important to demonstrate its safety for human applications using a battery of FDA-recommended biocompatibility tests," stated Dr. Sri Madhyastha, Vice-President, Research & Chief Scientific Officer of Kane Biotech Inc. "After completing all the tests, the biocompatibility data will be used to prepare the FDA Investigational Device Exemption (IDE) package for submission".
http://www.kanebiotech.com
Advanced hydrogel promotes GI wound healing