MALVERN, Pa., May 9, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that The Journal of Urology has published on its website, the Company’s phase IIb clinical trial of XIAFLEX® (collagenase clostridium histolyticum or CCH) a novel, first-in-class, biologic for the potential nonsurgical treatment of Peyronie’s disease. Top line data from this trial has been previously reported by the Company. The study will be included in the June 2012 print version of The Journal of Urology.
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The phase IIb study was designed to measure efficacy endpoints of improvement in penile curvature deformity and improvement in patients’ psychological and physical symptoms using the Company’s proprietary Peyronie’s Disease Questionnaire (PDQ). Overall, XIAFLEX demonstrated a statistically significant change compared to placebo at 36 weeks in both improvement in penile curvature deformity (p=0.001) and the PDQ bother domain (p=0.046). XIAFLEX was well-tolerated and the most common treatment related adverse events in the phase IIb study were consistent with adverse events reported in previous Peyronie’s disease trials with XIAFLEX, which included injection site bruising, edema and pain.
“Peyronie’s disease can have a devastating impact on patients and their partners, not only physically but psychologically and emotionally,” said Martin Gelbard, MD, IMPRESS investigator and clinical faculty member of UCLA School of Medicine Division of Urology. “Obtaining a statistically significant reduction in penile curvature deformity and improvement in Peyronie’s disease bother without the risks of surgical intervention would represent a considerable advantage for eligible patients suffering from Peyronie’s disease.”
A total of 145 patients evaluable for efficacy enrolled in 12 clinical sites across the U.S., with 109 patients receiving XIAFLEX as a series of intralesional injections and 36 receiving placebo in the study. A total of 137 of all eligible patients (93.2%) received all 6 injections per the protocol. The treatment and placebo arms were also randomized to test for a benefit with the addition of penile modeling versus no modeling (1:1). Modeling refers to massaging of the plaque and is intended to maximize the enzymatic effect of the XIAFLEX injection in the plaque.
“We are encouraged by the clinical profile of XIAFLEX for the potential treatment of Peyronie’s disease, which emerged from this phase IIb trial. Ultimately our goal is to provide an effective and well-tolerated solution to physicians and their patients with this troubling disease. These phase IIb results further support this clinical profile,” said James Tursi, M.D., Auxilium’s Chief Medical Officer. “We expect that the pivotal phase III data from our IMPRESS trials, anticipated later this quarter, will continue to expand our knowledge of the treatment of this disease and hopefully will lead to an FDA-approved treatment that may help patients who have few if any effective options.”
Newly Published Efficacy Data
- The previously released efficacy data are summarized below in table 1. Additionally, the baseline scores and change at 36 weeks from baseline for the “with modeling” and “without modeling” arms, which have not been presented before, are summarized within table 1.
- At week 36 a low to moderate correlation was observed between the degree of penile curvature deformity, and the PDQ domains of symptom bother (r = 0.22, p = 0.01), intercourse discomfort (r = 0.2, p = 0.02) and intercourse constraint (r = 0.42, p < 0.001).
- Based on a post-hoc sub-group analysis, the Company believes that the results from the non-modeling placebo group may have been greatly influenced by a higher relative percentage of patients with a shorter duration of disease relative to other arms. Of the 16 patients in the non-modeling placebo group, five patients had an apparent spontaneous resolution with a penile curvature deformity improvement of >40 %. Four of these patients had a Peyronie’s disease history of <12 months and the fifth had a 15 month disease history. The Company believes that this imbalance may help to explain the higher than expected placebo response in the no modeling arm as spontaneous resolution may be more common in the earlier phase of the disease.
- The Company believes that the PDQ has been validated for use in its phase III IMPRESS (The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) trials by data from 134 patients (100 XIAFLEX; 34 placebo) following this phase IIb trial and end of phase II discussions with the U.S. Food and Drug Administration (FDA).
Table 1: Phase IIb Efficacy Endpoints (36 weeks after First Injection)
