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BioSpecifics Technologies Corp. Announces Positive Top-line Data from Phase 2 Clinical Trial of CCH for the Treatment of Human Lipoma
Date:1/8/2014

CH in marketed indications, ranging from 0.058mg (10% of commercial dose) to 0.44mg (75% of commercial dose). The primary efficacy outcome was reduction in lipoma visible surface area as measured by caliper. Data showed patients in the highest dose group (75% of commercial dose) achieved the best efficacy results with an average of 67% reduction of lipoma visible surface area as measured by caliper at six months post-treatment. Additionally, data demonstrated that 75% of patients in the highest dose group achieved reduction of 50% or more in lipoma visible surface area.

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

"We are pleased with the results of this Phase 2 study and believe they indicate strong potential for CCH in human lipomas," said Dr. Zachary Gerut, M.D., Director of the Aesthetic Surgery Center in Hewlett, New York and Lead Investigator of the study. "A non-surgical therapy would be particularly relevant to patients with multiple lipomas. These patients require surgery with multiple excisions, each of which can have complications such as hematoma necessitating further surgery."

BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium) has the option to exclusively license development and marketing rights to the human lipoma indication following completion of a new trial, which would trigger an opt-in payment and potential future milestone and royalty payments from Auxilium.

About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications to date. Injectable collagenase i
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SOURCE BioSpecifics Technologies Corp.
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