SAN DIEGO, CA USA (Press Release) - May 6, 2013 - According to data from the Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies (IMPRESS) I and II phase three trials, men who received injectable treatments of collagenase clostridium histolyticum (CCH), an enzyme that breaks down fibrous scar tissue, showed improvement in both penile curvature deformity and Peyronie’s disease symptom bother.
The study will be presented to reporters during a special press conference at the 108th Annual Scientific Meeting of the American Urological Association (AUA) Monday, May 6 at 10:30 a.m. The presentation will be held at the San Diego Convention Center, San Diego, CA.
Peyronie’s disease is the development of fibrous scar tissue inside the penis and affects an estimated 65,000 to 120,000 men each year, most commonly between the ages of 45 and 60. It can be a physically and emotionally devastating disorder, resulting in curved and occasionally painful erections, as well as varying degrees of sexual dysfunction, emotional distress and depression. The cause of Peyronie's disease has yet to be completely understood; however factors such as injury to the penis, inherited traits and immune system disorders have been thought to play a role.
The IMPRESS I (N=417) and II (N=415) phase three studies examined outcomes in penile curvature deformity and symptom bother of men who received CCH injections vs. placebo. Subjects were stratified by degree of penile curvature deformity at baseline (30°to 60°vs 61° to 90°) and randomized to CCH or placebo (2:1 in favor of CCH). Results from a post-hoc meta-analysis showed CCH-treated subjects had a mean 34 percent improvement in penile curvature deformity compared with a mean 18.2 percent improvement in placebo-treated subjects. Mean change in Peyronie’s disease symptom bother score also significantly improved in patients treated with CCH.
“This study suggests CCH treatment can have both physical and psychological improvements on those suffering with Peyronie’s disease,” said Tobias Kohler, MD, Assistant Professor of Surgery, Division of Urology, SIU School of Medicine. “The potential for offering patients an effective in-office medical treatment that does not involve surgery would truly advance the standard of care we as physicians are able to provide.”
CCH is currently under review by the United States Food and Drug Administration (FDA), for the treatment of Peyronie's disease. CCH was granted orphan drug designation in the United States by the FDA in January 1996 and, if approved by the agency, is expected to be the first and only biologic therapy indicated for the treatment of Peyronie’s disease.
NOTE TO REPORTERS: Experts are available to discuss this study outside normal briefing times. To arrange an interview with an expert, please contact the AUA Communications Office at the number above or e-mail .
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 19,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.
[ PRESS RELEASE ]