Specialty biopharmaceutical company Auxilium Pharmaceuticals, Inc. (AUXL) Wednesday revealed data from its phase IIb clinical trial for Xiaflex, or collagenase clostridium histolyticum, in the treatment of Peyronie's disease.
The phase IIb study was designed to measure efficacy endpoints of improvement in penile curvature and improvement in patients' sexual quality of life using Auxilium's Peyronie's disease Patient Reported Outcome, or PRO, questionnaire. Overall, Xiaflex demonstrated a statistically significant change compared to placebo at 36 weeks in improvement in penile curvature and the PRO Peyronie's disease bother domain, the company said.
As part of the study, as many as 145 patients evaluable for efficacy enrolled in 12 clinical sites across the U.S. Hundred and nine patients received Xiaflex as a series of intralesional injections and 36 patients received placebo.
In patients who received Xiaflex, a mean improvement of 29.7% in penile curvature from baseline to 36 weeks was seen, compared to an 11.0% mean improvement in curvature seen in placebo patients. Also, in patients who received Xiaflex, 60.5% of patients achieved the endpoint of at least a 25% reduction in angle of curvature, in comparison with 25.0% of placebo patients achieving at least a 25% reduction in angle of curvature.
In the PRO Peyronie's disease bother domain, the overall Xiaflex treatment arm experienced a benefit in mean change in score from baseline to 36 weeks, which was significantly better than the overall placebo arm benefit, the company added.
Xiaflex was well-tolerated and the most common adverse events in the study included injection site bruising, edema and pain, consistent with adverse events reported in previous Peyronie's disease trials with Xiaflex.
Auxilium plans to have an end of phase II meeting with the FDA in the second quarter of 2010 to discuss the validation of the PRO, phase IIb clinical results and phase III clinical trial design for Xiaflex for the treatment of Peyronie's disease. Auxilium and its European partner Pfizer plan to request a meeting to discuss phase IIb results with European health authorities.
According to Armando Anido, Auxilium's Chief Executive Officer and President, "We believe the results from this trial provide a meaningful step forward to a better understanding of the treatment of Peyronie's disease with Xiaflex. We expect to meet with the FDA in the second quarter of 2010 to discuss a proposed phase III plan that potentially could be started in the second half of 2010."
AUXL closed Tuesday's regular trade at $32.50, down from the previous close of $32.62, on 343,200 shares.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.