Top-line results from Auxilium XIAFLEX palpable cord study in Dupuytren's contracture subjects

Sep 7 2011

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, patients were monitored for safety and pharmacokinetics over 90 days.  The breakdown of cords that were treated concurrently was:

• Five patients with a single finger containing both an MP and PIP joint,
• Five patients with two MP joints on two separate fingers,
• Two patients with a single MP and PIP joint on two separate fingers.

There was no measurable systemic absorption of XIAFLEX, and no severe local adverse events, drug related serious adverse events, or systemic reactions were reported.  A complete analysis of trial data is pending and the Company is seeking publication of full results in an appropriate medical journal.  A larger 60 patient clinical trial is scheduled to begin by mid-September in the U.S. and Australia to assess the efficacy and safety of multiple concurrent injections of XIAFLEX in subjects with multiple Dupuytren's contractures caused by palpable cords.