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Auxilium Pharmaceuticals Inc Announces Encouraging Top-line 30-day Data From Xiaflex (cch) Phase Ib Study In Cellulite


Thursday, 13 Dec 2012 07:00am EST 

Auxilium Pharmaceuticals Inc 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. 

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