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news.Kane Biotech's DispersinB wound spray has passed the FDA-recommended sensitisation test that was conducted by WuXi AppTec in compliance with Good Laboratory Practice (GLP).
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The in-vivo maximisation sensitisation test method is designed to evaluate the allergenic potential or sensitising capacity of DispersinB wound spray.
According to the company, the biocompatibility results confirm that DispersinB wound spray is non-cytotoxic, non-mutagenic and non-genotoxic.
The company expects that the 13-week sub-chronic toxicity test results will be completed in Q1 2011, and is planning on submitting the Investigational Device Exemption (IDE) regulatory package to the FDA in Q2 2011.
Kane Biotech Research vice president and chief scientific officer Sri Madhyasta said that the non-irritating and non-sensitising properties of DispersinB have now been confirmed and these results are a critical step in complying with FDA biocompatibility requirements for topical wound care products.
"Once the remaining sub-chronic toxicity study is completed, we will have all the biocompatibility data required for preparing the FDA-IDE package," Madhyasta said.
Kane Biotech president and CEO Gord Froehlich said that DispersinB wound spray is their lead product in development and they are very encouraged by the biocompatibility test results that we have seen.
"In addition to our lead product, we have a number of collaborative research and development agreements in place with various companies who are testing our biofilm technologies," Froehlich said.