WINNIPEG, Manitoba (September 28, 2009) - Kane Biotech Inc. (TSX-V: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”.
About Kane Biotech Inc.
Kane Biotech is a biotechnology company engaged in the development of products to prevent and remove biofilms. Biofilms are a major cause of a number of serious medical problems including chronic infections and medical device related infections. They develop on surfaces such as catheters, prosthetic implants, teeth, lungs and the urogenital tract. Biofilms are pervasive, costly to deal with and are involved in approximately 80% of all human bacterial infections. The healing of chronic wounds alone costs the United States health care system $20 Billion per year.
Kane Biotech uses patent protected technologies based on molecular mechanisms of biofilm formation/dispersal and methods for finding compounds that inhibit or disrupt biofilms. The Company has evidence that these technologies have potential to significantly improve the ability to prevent and/or destroy biofilms in several medical and industrial applications.