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BioSpecifics Technologies Corp. Announces Top-line Data from Phase 2 Trial of CCH for Canine Lipoma
Date:12/23/2013

h was not statistically significant. The percent change at 90 days in mean visible surface area measured by caliper showed a difference of -24.18% (p=0.09), which approached statistical significance. Among those dogs whose lipomas decreased by 50%, the results achieved statistical significance and showed that the visible surface area as measured by caliper decreased by 50% or more in 47.4% of CCH-treated dogs (9 out of 19) versus 5.9% of placebo-treated dogs (1 out of 17), with a p-value of 0.0084. A questionnaire administered to pet owners, while blinded to the study, showed 84.2% satisfaction with the results of CCH treatment versus 33.4% satisfaction with the placebo results (p=0.005).

There were no drug-related serious adverse events reported during the trial. The most frequent treatment-related adverse events were local injection site reactions including bruising, injection site swelling, injection site pain and injection site edema. These adverse events are consistent with those seen previously in clinical experience in humans.

"We believe that this minimally-invasive approach of CCH for the treatment of canine lipomas has the potential to be a very important development in veterinary medicine," said Dr. Sarit Dhupa, Director of Surgery at California Veterinary Specialists and Lead Investigator on the Chien-804 trial. "At present, the standard of care therapy available to treat canine lipomas is invasive surgery. This clearly can result in higher morbidity, a greater risk of mortality particularly to older pets and puts a greater financial burden on pet owners. A minimally-invasive option would revolutionize the way we treat this disease."

BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium) has the option to exclusively license development and marketing rights to the canine lipoma indication, which would trigger an opt-in payment and potential future milestone and roya
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SOURCE BioSpecifics Technologies Corp.
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