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Auxilium Pharmaceuticals, Inc. Announces First Patients Dosed in XIAFLEX® Phase Ib Cellulite Study
Date:1/26/2012

ss, and pharmacokinetics of XIAFLEX for the treatment of EFP. Topline results are expected in the second half of 2012.

"Dosing in the cellulite clinical trial represents another important development milestone for Auxilium as we advance a fourth potential indication of XIAFLEX into the clinic, further diversifying XIAFLEX's growing pipeline," explained Adrian Adams, Chief Executive Officer and President of Auxilium. "We believe cellulite represents a significantly undertreated condition and that innovative approaches such as XIAFLEX may one day be a viable solution for treatment."

To qualify for the study, participants must have EFP in the posterolateral thighs and/or buttocks for at least 12 months prior to a screening visit. Following screening and determination of eligibility, study participants will be assigned to one of seven groups that vary in treatment dose, injection concentration and volume. 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.  The total dose of XIAFLEX that will be administered into the targeted area will range between 0.0029 mg and 0.116 mg; these doses represent between 0.5% and 20% of the dose used in a single injection for Dupuytren's contracture (0.58 mg). Safety will be evaluated through the collection of adverse events, as well as a targeted assessment of local reactions to the treatment. The treatment effectiveness will be evaluated by investigator and patient assessments, as well as 3-D photographic imaging techniques. More information on the study will be posted at www.clinicaltrials.gov.

About Cellulite
Cellulite, also known medically as edematous fibrosclerotic panniculopathy, describes a pathologic inflammatory condition, in which lobules of subcutaneous adipose tissue extend into the dermal layer.  These changes can visibly affect th
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