Auxilium Pharmaceuticals Inc. (AUXL)

[surf1944]

7:04AM Auxilium Pharma announces additional Phase III XIAFLEX data to be presented at SMSNA meeting; results from the open-label sub-study were consistent with the double-blind placebo-controlled studies (AUXL) 23.29 : Co announced that additional data will be presented from its IMPRESS trials, the phase III studies that assessed XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease. A baseline analysis from IMPRESS focuses on the psychosocial impact on men with PD, specifically the level of PD bother and distress associated with PD as related to the degree of penile curvature deformity. At baseline, results showed that all degrees of curvature deformity evaluated in the studies may be associated with high levels of bother and distress. Specifically, more than half (58%) of patients with lesser levels of curvature deformity (30 to 60 degrees) reported that they were "very bothered" or "extremely bothered" about their condition. Additional results showed that 73% of patients with curvature deformity of 60 to 90 degrees were also "very bothered" or "extremely bothered" about their condition. A high level of patient-reported moderate to severe distress over PD was also noted among subjects with curvature deformity of 30 to 60 or 60 to 90 degrees (80.5% and 90.5%, respectively). In addition, photographs and data will presented from a subset of IMPRESS patients involved in the first study ever to use 3-D photographic technology for 360 degree assessment of penile curvature deformity in PD patients. The sub-study was conducted as part of an open-label phase III study allowing physicians to visualize the changes in penile curvature deformity for a patient after each XIAFLEX treatment cycle, including images from the patient's perspective. Patients were followed for 36 weeks and penile curvature deformity was 3-D photographed prior to each treatment cycle and at the end of the study. The results from this open-label sub-study were consistent with the double-blind placebo-controlled studies.