Auxilium doses first patients in Xiaflex Phase Ib trial
Auxilium Pharmaceuticals has dosed first patient in its phase Ib trial of Xiaflex (collagenase clostridium histolyticum) to treat edematous fibrosclerotic panniculopathy (EFP, cellulite).
Xiaflex (collagenase clostridium histolyticum) is a biologic for the treatment of adult Dupuytren's contracture patients with a palpable cord.
Xiaflex treatment is intended to target and lyse, or break, those collagen tethers with the goal of releasing the skin dimpling and potentially resulting in smoothing of the skin.
The phase Ib study is a single site, open-label dose-escalation study, whose objectives are to assess the safety, effectiveness, and pharmacokinetics of Xiaflex for the treatment of EFP.
Subjects will receive 10 concurrent injections (0.1 or 0.5 mL per injection) of Xiaflex via a standardized template over a targeted area (8 cm x 10 cm) of EFP.
Safety will be evaluated through the collection of adverse events, as well as a targeted assessment of local reactions to the treatment.
The effectiveness will be evaluated by investigator and patient assessments, as well as 3-D photographic imaging techniques.
The company expects the topline results in the second half of 2012.
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