Oct 11 2010
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company, today announced that the first subject has been dosed in the global phase III program of XIAFLEX® for the treatment of Peyronie's disease. Peyronie's disease is the development of scar tissue on the penis that can cause the penis to curve during erection, often interfering with or preventing intercourse and resulting in psychological distress or bother for the patient.
"Peyronie's disease is a devastating disease that is estimated to affect approximately 5% of adult men and, therefore, we are pleased to be moving forward into the phase III development of XIAFLEX," said Armando Anido, Chief Executive Officer and President of Auxilium. "We believe that there is significant unmet medical need for a nonsurgical alternative for Peyronie's disease, and we have been encouraged by the enthusiasm that we have perceived among the urology community and their prospective patients for participating in our phase III program. We anticipate completing enrollment for the double-blind studies in the first quarter of 2011 and reporting top-line results in first half of 2012."
Our late stage global development plan for XIAFLEX will consist of four clinical studies and will be known by the acronym IMPRESS – The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies. There will be two randomized, double-blind, placebo-controlled phase III studies, which are expected to enroll at least 600 patients at approximately 70 sites in the U.S. and Australia, with a 2:1 ratio of XIAFLEX to placebo. There also will be one open label study, which is expected to enroll at least 250 patients, at approximately 30 sites in the U.S., EU and New Zealand, and one pharmacokinetic study, which should enroll approximately 16 patients. XIAFLEX will be administered two times a week every six weeks for up to four treatment cycles (2 x 4). Each treatment cycle will be followed by a penile modeling procedure. Patients will be followed for 52 weeks post-first injection in the double-blind studies and for 36 weeks in the open label trial.
The trials' co-primary endpoints are the change from baseline in the Peyronie's disease bother domain of the Peyronie's Disease Questionnaire (PDQ) compared to placebo and percent improvement from baseline in penile curvature compared to placebo. The PDQ will have at least three domains, which will include Peyronie's disease bother, severity of psychological and physical symptoms of Peyronie's disease, and penile pain. Safety measurements will include adverse event monitoring, immunogenicity testing and clinical labs.
"We are encouraged by the clinical profile of XIAFLEX, which emerged from our earlier phase IIb clinical trial in Peyronie's disease. XIAFLEX was well-tolerated and produced clinically significant reductions in both penile curvature and disease bother," said Dr. Jim Tursi, Auxilium's Vice President of Clinical Research & Development. "Over the last six months, our team, in conjunction with the U.S. Food and Drug Administration (FDA), outside experts and men with Peyronie's disease, has spent a considerable amount of time and effort to refine the PDQ, which has now been accepted for use in the phase III clinical trials by the FDA's Study Endpoint and Label Development (SEALD) Division."
SOURCE Auxilium Pharmaceuticals, Inc.
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