Auxilium Pharmaceuticals, Inc. Announces Positive Top-Line Results from XIAFLEXÃ‚® Multi-Cord Study
MALVERN, Pa., Sept. 7, 2011 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL ), a specialty biopharmaceutical company, today announced positive top-line results from a pilot clinical study to assess safety, tolerability, and multiple-dose pharmacokinetics of XIAFLEX® (collagenase clostridium histolyticum) in adult Dupuytren's contracture subjects with multiple palpable cords. The tolerability profile following concurrent injection of two doses of XIAFLEX into palpable cords in the same hand is consistent with that demonstrated in pivotal clinical trials following a XIAFLEX injection into a single palpable cord.
"We were encouraged that multiple injections of XIAFLEX into the same hand concurrently have demonstrated a preliminary tolerability profile clinically similar to that of a single injection," said Dr. James P. Tursi, Chief Medical Officer at Auxilium. "Concurrent multiple injections of XIAFLEX would offer hand surgeons the ability to treat several joints in the same hand at the same time, which would be similar to historical surgical interventions."
In this phase IIIb study, 12 adult subjects with 36 palpable cords were enrolled at a single site in Australia. All subjects were required to have Dupuytren's disease with at least three fixed-flexion contractures, excluding the thumb. Each subject was given a single injection of XIAFLEX and, if no severe local or systemic reaction was observed, concurrent injections of two doses of XIAFLEX were given into two palpable cords in the same hand. In the pivotal phase III clinical trials, only a single joint was treated with XIAFLEX and additional joints were required to be treated sequentially every 30 days. Following the multiple concurrent injections in the pilot study, patient