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BioSpecifics Technologies Corp. Announces Initiation of Phase 2b Trial of CCH for Treatment of Frozen Shoulder Syndrome
Date:12/13/2013

LYNBROOK, N.Y., Dec. 13, 2013 /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 that its partner Auxilium Pharmaceuticals, Inc. (Auxilium) has dosed the first patient in its Phase 2b study of collagenase clostridium histolyticum (CCH) for the treatment of frozen shoulder syndrome (adhesive capsulitis). Frozen shoulder is a clinical syndrome of pain and decreased motion in the shoulder joint thought to be caused by increased capsular collagen thickening and subsequent capsular contraction.

"We believe that there is significant potential for CCH in this indication as approximately 700,000 patients visit a physician each year with symptoms of frozen shoulder syndrome," commented Thomas L. Wegman, President of BioSpecifics. "With the recent approval by the U.S. Food and Drug Administration of XIAFLEX as a treatment for Peyronie's disease, the potential of collagenase as an effective treatment for many important conditions and diseases is becoming more and more evident. We look forward to exploring its efficacy in additional indications including cellulite, human and canine lipomas as well as uterine fibroids."

As reported by Auxilium today, the Phase 2b study is a double-blind, placebo-controlled study of the safety and efficacy of CCH for the treatment of Stage 2 (frozen stage) unilateral idiopathic frozen shoulder. The study will enroll approximately 300 adult men and women at approximately 35 sites in the U.S. and Australia. Subjects will be randomized 3:1 to receive CCH or placebo and will receive up to three ultrasound-guided injections of study drug. Each injection will be separate
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