BERKELEY, CA USA (UroToday) - An interview with James Tursi, MD followed the June 4, 2012 Auxilium Pharmaceuticals, Inc., announcement of positive top-line results from the IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials and 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 (PD).
Q. What are the noteworthy elements of these studies?
J. Tursi: XIAFLEX® (collagenase clostridium histolyticum or CCH) is the first and only potential biologic option for the treatment of Peyronie’s disease. Peyronie’s disease (PD) is a progressive disease resulting in penile curvature, deformity, and patient bother. Important considerations for PD include overall sexual function, psychological distress, and the impact of PD on interpersonal relationships.
Incorporating this understanding of the definition of PD, the two co-primary endpoints of these trials measure penile curvature deformity, and unique to these studies, measures the extent of disease bother.
Q. Can you describe the instrument used to measure patient bother in the trials?
J. Tursi: Working with the SEALD Division within the United States Food and Drug Administration (FDA) and a team of expert advisors, we developed and validated the Peyronie’s Disease Questionnaire (known as the PDQ) for use in the Phase III studies.
The PDQ is a disease-specific, self-administered, patient-reported outcome instrument designed to measure the symptoms and psychosexual impact of PD. The PDQ contains three domains that are scored individually and where a higher score means increased severity. The first domain is the Peyronie’s Psychological and Physical Symptoms. This domain asks about six items pertaining to patients’ concerns about damaging the penis, bending or collapsing the penis, trouble inserting an erect penis, difficulty with some positions, and awkwardness with some positions.
The second domain Penile Pain is comprised of three items about penile pain, typically occurring early in the disease progression. The items pertain to defining the last time the patient experienced non-erect penile pain, erect penile pain, and penile pain during intercourse. The third domain, called the Peyronie’s Symptom Bother, focuses on four items assessing patient bother. Questions are posed to determine if the patient is bothered by pain in his erect penis, bothered by the appearance of the penis, bothered by the PD during intercourse, and bothered by less frequent intercourse.
Q: What other key points would you note about IMPRESS I and IMPRESS II?
J Tursi: These trials enrolled 800 patients in less than 5 months’ time and had an approximate 90% enrollee completion rate. Clearly patients with PD are motivated to seek out a treatment option that works.
James P. Tursi, MD is the Chief Medical Officer for Auxilium Pharmaceuticals, a specialty biopharmaceutical company based in Malvern, Pennsylvania. Auxilium specializes in the development and commercialization of products serving unmet medical needs.
Dr. Tursi received his doctor of medicine degree from the Medical College of Pennsylvania. He subsequently completed his residency training at the Johns Hopkins Hospital and entered clinical practice in Southern New Jersey caring for indigent patients. He practiced medicine for over 10 years and created a medical education company, I Will Pass®, which assists physicians in the process of board certification.
He entered the pharmaceutical industry as a Medical Director for Procter and Gamble Pharmaceuticals. He worked on several products and in several therapeutic areas, including female sexual dysfunction, overactive bladder, and osteoporosis. His responsibilities included clinical development and medical affairs. He moved to GSK Biologicals in 2006 and he directed all medical affairs responsibilities for cancer vaccines in North America.
In March of 2009, he assumed responsibility of the Clinical R&D organization at Auxilium. As CMO, he is currently responsible for oversight of Medical Affairs, Clinical Development, Clinical Operations, Biometrics, Nonclinical activities and Medical Writing. He leads a team of 50 individuals involved in activities across several indications.
