Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX® for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. The Company 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 Company to seek Food and Drug Administration (FDA) approval and expansion of the Dupuytren's label. Based on research by SDI Health, LLC estimating that 35 to 40% of annual Dupuytren's surgeries in the US are performed to treat two or more cords concurrently, Auxilium is conducting these studies to seek a multicord indication for XIAFLEX from the FDA.
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 (AE's) 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. As in the phase III studies, most AEs resolved within 14 days. There have been no systemic hypersensitivity events reported in this trial or any of the previous XIAFLEX clinical studies reported to date. Auxilium intends to present additional data from the trial at a future medical conference.
"We are very pleased to announce this important new data exploring the utility of treating patients with multiple palpable cords and expect to begin a larger trial soon that, if successful, may allow us to seek expansion of the current Dupuytren's indication for XIAFLEX," said Adrian Adams, Chief Executive Officer and President of Auxilium. "We believe that physicians who treat Dupuytren's and their prospective patients would be receptive to the potential ability to treat more affected joints at a single treatment session using a non-surgical treatment alternative."
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.
The Company does not believe the rate of tendon / ligament injury following two concurrent injections is any different clinically from the overall experience with XIAFLEX to date and intends to continue to monitor for these events very closely. In the completed clinical study program, 4 of 1082 subjects in the program experienced a tendon rupture / ligament injury for a rate of 0.4 %. To date, approximately 20,000 patients have received commercial XIAFLEX injections in the United States with a reported overall tendon rupture / ligament injury rate of approximately 0.1%.
Auxilium is grateful to all the patients, investigators and Auxilium employees who contributed to these trials.
Auxilium Pharmaceuticals, Inc.