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BioSpecifics Technologies Corp. Announces Initiation of Phase 2 Clinical Study of CCH for Treatment of Lipoma
Date:8/8/2014

LYNBROOK, N.Y., Aug. 8, 2014 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. and XIAPEX® in the EU, announced today that it has injected the first patient in its placebo-controlled Phase 2 clinical trial of CCH for the treatment of lipoma. The Company expects to complete patient enrollment in this trial during the first quarter of 2015.

"Our initiation of this Phase 2 placebo-controlled clinical trial of CCH in patients with lipoma represents another important development milestone for BioSpecifics as we further advance our pipeline and continue to uncover the vast potential of injectable collagenase," commented Thomas L. Wegman, President of BioSpecifics. "Lipomas are common and affect 2% of the total human population. We hope to build upon the positive clinical data reported earlier this year, and to make progress toward potentially offering a nonsurgical therapy to patients with this condition."

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of CCH for the treatment of lipoma. Lipomas are encapsulated benign fatty tumors often detected as bulges under the skin. The study will be conducted at two centers in the U.S. and is expected to enroll 20 adult men and women presenting with at least two benign lipomas of similar size. Subjects will be randomized to have two lipomas treated in immediate succession; one with CCH and one with placebo.

The primary endpoint of the Phase 2 clinical trial is the reduction in the measureable surface area of the target lipomas, as determined by caliper, at six months post injection. The secondar
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