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BioSpecifics Announces Positive Results From Clinical Trial in Canine Lipomas
Date:1/6/2011

3/4 of the dose used in previous human clinical trials. Based on this dose escalation study the Company selected the dose for Chien-802.

Chien-802 was designed to evaluate the efficacy of injectable collagenase in canine lipoma in four healthy dogs with subcutaneous lipomas. Inclusion criteria required the lipoma to be benign, superficial and easily measureable. All dogs had a second lipoma that was untreated and used as a control. At 90 days post injection, in the three evaluable dogs, the lipoma size was 0%, 0% or 7% of the original size as measured by a CT scan. By contrast, the untreated lipomas were 129%, 113% and 128% of the original size at day 90. Thus, the treated lipomas showed a 97% reduction in the size of the lipoma and an increase in the size of the untreated controls of 23%.  Based on the positive results from Chien-802, BioSpecifics has begun enrollment in a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of purified collagenase for injection for the treatment of canine lipomas.

The Company's preliminary results from an ongoing marketing survey indicate that veterinarians perform lipoma excision surgery on an average of 25 dogs per year, costing approximately $635 million annually.  

The American Veterinary Medical Association estimates that 47,000 veterinarians practice on small animals. Based on the data from BioSpecifics' survey of veterinarians, the veterinarians estimate that they would use injectable collagenase on an average of 22 dogs per year. BioSpecifics believes that the total potential market for purified collagenase for the treatment of canine lipomas could be 1 million injections in the Unites States annually.

BioSpecifics' strategic partner, Auxilium Pharmaceuticals, Inc. (Auxilium), has the option to license development and marketing rights to this indication, which would trigger an opt-in payment and potential future milestone payments from Auxilium t
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