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"We are very pleased that our partner has chosen to advance this trialinto a Phase IIb based on our extremely encouraging IIa results that showed astatistically significant reduction of angle of penile curvature andimprovement in sexual satisfaction," stated Thomas Wegman, President ofBioSpecifics Technologies Corp. "Peyronie's disease affects over 1 million menworldwide and there are no currently effective pharmaceutical therapies. Weare happy to be one step closer to making this minimally invasive therapyavailable for those that need it and we look forward to the anticipated trialresults that will be announced by the end of 2009."
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The Phase IIb study is a randomized, double-blind, placebo-controlledstudy that is designed to assess the safety and efficacy of XIAFLEX, whenadministered two times a week every six weeks for up to three treatment cycles(2 x 3), in subjects with Peyronie's disease. The study will involve at least120 patients at approximately 11 sites throughout the U.S., and patients willbe monitored for 36 weeks following the first injection.
The trial is also designed to validate a proprietary Peyronie's PatientReported Outcome (PRO) questionnaire, which will measure several domains ofpatients' sexual quality of life, over a 36 week period. The four domainsmeasured by the PRO are penile pain, Peyronie's disease bother, intercoursediscomfort and intercourse constraint.
To qualify for the study, patients must be able to maintain a rigiderection and have a penile contracture between 30 and 90 degrees. Patientswill be stratified by the degree of penile curvature (i.e. 30 degrees to 60degrees versus > 60 degrees) and then randomized into 4 treatment groups toreceive either XIAFLEX or placebo with or without modeling of the penileplaque. Modeling refers to massaging of the plaque after the second injectionof a treatment series and is intended to maximize the enzymatic effect of theXIAFLEX injection in the plaque. Patients will be randomized in a 3:1 ratio ofXIAFLEX to placebo and a 1:1 ratio to receive penile plaque modeling or nomodeling.
About Peyronie's Disease
Peyronie's disease is characterized by the presence of a collagen plaqueon the shaft of the penis, which can distort an erection and make intercoursedifficult or impossible in advanced cases. The plaque is not elastic and itdoes not stretch during erection. In some mild cases, the plaque can resolvespontaneously without medical intervention. The most common plaque forms onthe top of the penis causing the penis to arc upward. In severe cases, thepenis can be bent at a 90-degree angle during erection. Significantpsychological distress has been noted in patients with Peyronie's disease whoare sexually active. Frequent patient complaints include increased pain,painful erections, palpable plaque, penile deformity, and erectiledysfunction. Patients with Peyronie's disease have been reported to have anincreased likelihood of having Dupuytren's disease, frozen shoulder, plantarfibromatosis, knuckle pads, hypertension and diabetes. Peyronie's diseasetypically affects males in the range of 40-70 years. The cause of Peyronie'sdisease is unknown, although some investigators have proposed that it may bedue to trauma or an autoimmune component. A number of researchers havesuggested that the incidence of Peyronie's disease has increased due to theuse of erectile dysfunction drugs.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that hasdeveloped and licensed in
