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news.Auxilium Pharmaceuticals, a specialty biopharmaceutical company, has announced that the first patients have been dosed in the company's US Phase IIb trial of Xiaflex for the treatment of Peyronie's disease.
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The Phase IIb study is a randomized, double-blind, placebo-controlled study that is designed to assess the safety and efficacy of Xiaflex, when administered two times a week every six weeks for up to three treatment cycles (2×3), in subjects with Peyronie’s disease. The study will involve at least 120 patients at approximately 11 sites throughout the US, and patients will be monitored for 36 weeks following the first injection.
The trial is also designed to validate a proprietary Peyronie’s patient reported outcome (PRO) questionnaire, which will measure several domains of patients’ sexual quality of life, over a 36 week period. The four domains measured by the PRO are penile pain, Peyronie’s disease bother, intercourse discomfort and intercourse constraint.
To qualify for the study, patients must be able to maintain a rigid erection and have a penile contracture between 30 and 90 degrees. Patients will be stratified by the degree of penile curvature (30° to 60° versus > 60°) and then randomized into four treatment groups to receive either Xiaflex or placebo with or without modeling of the penile plaque.
Modeling refers to massaging of the plaque after the second injection of a treatment series and is intended to maximize the enzymatic effect of the Xiaflex injection in the plaque. Patients will be randomized in a 3:1 ratio of Xiaflex to placebo and a 1:1 ratio to receive penile plaque modeling or no modeling.
Armando Anido, CEO and President of Auxilium, said: “We believe Xiaflex is a company-transforming product for Auxilium and the excitement surrounding this trial in the urological community that treats Peyronie’s patients has been resounding. Additionally, the response from potential patients has been highly encouraging, and as a result, we believe we will complete enrollment in this study in the first quarter of 2009.
We are extremely pleased to achieve this important development milestone in Peyronie’s disease, a potential second indication for Xiaflex, and we look forward to having the results of the trial by the end of 2009.”