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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

LYNBROOK, N.Y., Jan. 8, 2014 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in the EU, today announced top-line data from the Phase 2 dose escalation clinical trial of collagenase clostridium histolyticum (CCH) for the treatment of human lipoma. Lipomas are benign fatty tumors that usually present as painful or palpable lumps in the subcutaneous tissues. The primary efficacy outcome of active reduction of the visible surface area of the lipoma as measured by caliper was met, combining all patients (p<0.0001). There were no serious adverse events reported during the trial.

"The top-line data from this Phase 2 trial further demonstrate the strong safety and efficacy profile of CCH and are consistent with the results from the prior Phase 1 clinical trial that showed reduction of lipoma size following treatment with CCH. We are excited by the possibility of offering a non-surgical treatment option to the estimated 575,000 patients who receive this diagnosis annually in the U.S.," commented Thomas L. Wegman, President of BioSpecifics. "Based on the results from both studies reported to date, we intend to initiate a placebo-controlled study to further assess the efficacy and safety of CCH for the treatment of human lipoma in the first half of 2014. We also plan to explore the potential to expand CCH into new pipeline indications with unmet medical needs this year."

This Phase 2 open-label single-center dose escalation study assessed the safety and efficacy of CCH in 14 patients with lipoma, divided into four dose cohorts. Each patient received a single injection of CCH in one of four ascending doses based on the current commercial dose of C
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