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BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite
Date:8/21/2014

LYNBROOK, N.Y., Aug. 21, 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, today announced positive, statistically significant results from a randomized, double-blind Phase 2a study of CCH for the potential treatment of cellulite, or edematous fibrosclerotic panniculopathy. The results showed that all three doses of CCH used in the study, including a low, medium and high dose, demonstrated an improvement in the appearance of cellulite as measured by the trial endpoints of physician and patient-assessed improvements. CCH was well-tolerated by all dose groups with most adverse events being mild to moderate and primarily limited to the local injection area.

"These positive results are very encouraging, particularly because both patients and physicians saw a statistically significant improvement in the appearance of cellulite after CCH treatment," commented Thomas L. Wegman, President of BioSpecifics. "The market for cellulite treatment is large, which makes these data very exciting for the prospective commercial success of CCH in this indication. The results also position CCH as a potential treatment for other aesthetic needs, so we are eager to see continued progress by Auxilium in initiating a subsequent Phase 2b trial of CCH in cellulite in the second quarter of 2015."

The Phase 2a study was conducted by BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium) and enrolled 150 women between the ages of 18 and 45 in the U.S. Each subject received up to three treatment sessions of drug or placebo according to randomization (5 high-dose (0.84mg): 5 mid (0.48mg): 5 l
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