Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company, today announced that new analyses of data were presented from its clinical program and pivotal IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the Phase 3 studies that evaluated XIAFLEX® (collagenase clostridium histolyticum or CCH) for the treatment of Peyronie's disease (PD). These data were presented at the American Urological Association (AUA) Meeting held in Orlando, Florida on May 16-21, 2014.
"XIAFLEX is the first and only FDA-approved treatment for Peyronie's disease in men with a palpable plaque and a penile curvature deformity of 30 degrees or greater at the start of therapy," said James Tursi, M.D., Chief Medical Officer of Auxilium. "We believe this may offer patients, their partners and their physicians an important treatment option for this devastating disease."
Highlights of the information presented include:
- 75 percent of men with PD treated with XIAFLEX in the IMPRESS pivotal studies had a clinically meaningful improvement in their penile curvature deformity by the end of the trials. These subjects reported an improvement of 25 percent or greater in penile curvature deformity.
- Peyronie's plaque tissue was excised and exposed to XIAFLEX in vitro. XIAFLEX preferentially degraded type I and type III collagen, predominant collagen types in PD plaques, while sparing type IV collagen present within connective tissues that surround arteries, large veins and nerves. There was no detectable effect of XIAFLEX on the structure of blood vessels, nerves, and fibroblasts at any dose evaluated.
- An injection simulator using a "smart syringe" was developed to provide clinicians an opportunity to practice the XIAFLEX injection technique. Use of such a model in physician training may increase urologists' familiarity with the injection technique for XIAFLEX treatment of PD by providing both visual and tactile feedback during simulated injection.
- The administration of a second XIAFLEX injection 1, 2 or 3 days after the first injection during Treatment Cycle 1 did not impact the safety or effectiveness of XIAFLEX in the treatment of Peyronie's curvature deformity evaluated at Week 6. The improvement in curvature deformity and safety measurements were comparable regardless of when the second injection was administered during the first treatment cycle. These data support flexibility in planning XIAFLEX treatment cycles.
Auxilium Pharmaceuticals, Inc.