7:01AM Auxilium Pharma announces 'positive' top-line data from XIAFLEX Phase IIIb Dupuytren's contracture multicord study (AUXL) 26.70 : Co enrolled 60 patients at eight sites throughout the U.S. and Australia. In the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the co to seek FDA approval and expansion of the Dupuytren's label. In this phase IIIb multicord study, 60 patients received two concurrent injections of 0.58 mg of XIAFLEX per affected hand and efficacy was based on a single injection per contracted joint. At 30 days, 60% of all joints, 76% of metacarpophalangeal (MP) and 33% proximal interphalangeal joints achieved clinical success (defined as joint correction to 0 to 5 degrees) following this single injection when two 0.58 mg doses of XIAFLEX were administered concurrently into the same hand. These response rates are numerically higher than the response rates seen after the first single injection in the double-blind placebo controlled phase III studies. The most common adverse events reported in this phase IIIb trial were bruising, pain and swelling at the treatment site. These AE's were comparable to the previous trials with certain events being slightly higher with two concurrent injections; bruising, pain, pruritus, and lymphadenopathy. Co intends to present additional data from the trial at a future medical conference. There were two related serious adverse events reported in the phase IIIb trial: an A2-A4 pulley rupture/ligament injury of the middle finger after middle and ring finger MP joint injections and a 24 hour hospitalization for pain control after two injections into a little finger.
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