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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

d by a minimum of 21 days. All subjects will also perform home shoulder exercises after the first injection.

The primary endpoint of the Phase 2b study will be change in degrees from baseline to the Day 95 follow-up visit in active forward flexion in the affected shoulder compared to placebo. Patients will also be assessed using the American Shoulder and Elbow Surgeons (ASES) Scale for function and pain as well as additional patient reported outcome measures.  Safety assessments will be made during all study visits and immunogenicity testing will be performed at screening and at the end of the study.

About Frozen Shoulder Syndrome

Frozen shoulder syndrome is a clinical syndrome of pain and decreased motion in the shoulder joint that is estimated to affect 20 to 50 million people worldwide with a slightly higher incidence in women. Currently, the most common treatments for frozen shoulder syndrome are extensive physical therapy, corticosteroids and/or arthroscopy, as well as certain pain drugs.

About BioSpecifics Technologies Corp.

BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications to date. Injectable collagenase is approved for marketing as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. for the treatment of adult Dupuytren's contracture patients with a palpable cord in the palm and for Peyronie's disease in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy by BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium). Auxilium is partnered with Actelion Pharmaceuticals Ltd. for the marketing of XIAFLEX in Canada and Australia, and Swedish Orphan Biovitrium AB for the marketing of XIAPEX® (the EU tradename for CCH) in 71 Eurasian and African countries for the treatment of Dupuytren's
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