Auxilium Reports Encouraging Data in XIAFLEX Phase Ib Study in Cellulite

Auxilium Pharmaceuticals

, 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