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Auxilium Pharmaceuticals Announces Encouraging Top-line 30-Day Data From XIAFLEX® (CCH) Phase Ib Study In Cellulite

MALVERN, Pa., Dec. 13, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced top-line Day 30 data for collagenase clostridium histolyticum or CCH for the potential treatment, if approved by the U.S. Food and Drug Administration (FDA), of adult patients with edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite.  The phase Ib study is a single site, open-label dose-escalation study that enrolled 99 women between 21 and 60 years of age. Study participants were assigned to one of 11 arms, each of which varied in treatment dose, injection concentration and volume, to receive a single injection of CCH, divided into 10 aliquots over a pre-defined 8x10cm template around a target dimple.  The objectives of the study are to assess the safety and effectiveness of a single injection of CCH for the treatment of EFP at 30, 60 and 90 days across multiple dosing arms.  Pharmacokinetic evaluations were made as well.  Across all dosing arms, 60 patients (63%) who were treated experienced some improvement in the volume of their target cellulite dimple at Day 30.  Overall, 17% of patients had a greater than or equal to 30% improvement in their target dimple at Day 30; however, multiple CCH dosing arms had more than 40 percent of patients experience an improvement greater than or equal to 30% in their target dimple at Day 30.  Cellulite has been reported to occur in 85-98% of post-pubertal females and rarely in men; the condition is believed to be prevalent in women of all races. 1,3


"We are pleased with the safety profile and encouraging potential efficacy of CCH, with initial phase Ib results demonstrating that some doses of CCH exhibited potential improvement in dimple volume and were well tolerated with no dose-limiting side effects," said Dr. James Tursi, Chief Medical Officer at Auxilium. "We look forward to advancing the clinical development of CCH in cellulite, which, if successful, we believe could lead to the first FDA-approved, office-based biological treatment option for cellulite that is supported by scientific results."

Treatment-related adverse events with CCH were mostly localized bruising, injection site discomfort and swelling, and all such events resolved without intervention, which are all consistent with XIAFLEX use in other indications.  There were no new adverse events and no drug-related serious adverse events reported. 

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