Æterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, reported dosing has commenced with its flagship product candidate, cetrorelix, the company's lead luteinizing hormone-releasing hormone (LHRH) antagonist compound, in the first study of its phase 3 programme in benign prostatic hyperplasia (BPH).
As previously announced, the first study of the phase 3 programme titled, "Cetrorelix pamoate intermittent IM dosage regimens in patients with symptomatic BPH, a 1-year placebo-controlled efficacy study and long-term safety assessment", will assess an intermittent dosage regimen of cetrorelix as a potential safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms, under the supervision of Lead Investigator, Herbert Lepor, Professor and Martin Spatz chairman of Urology, at the New York University School of Medicine.
"We are very excited to report our first patients being treated with cetrorelix in our extensive phase 3 programme in BPH," stated David J Mazzo, Ph.D., president and CEO of Æterna Zentaris. "We expect recruitment to progress swiftly over the remainder of the year as the vast majority of our 10 centres in Canada and 30 centres in the United States will be up and running by the end of the month. This event also marks a key milestone in our drug development strategy as it brings our flagship product candidate yet another step closer to an NDA filing. We strongly believe that given its known attributes, cetrorelix has the potential to successfully penetrate a $4 plus billion market."
Herbert Lepor, Professor and Martin Spatz chairman of Urology at the NYU School of Medicine and Lead Investigator of the phase 3 programme added, "Having been involved in BPH research for more than 20 years and considering the strong prior data on cetrorelix, I am pleased that the phase 3 program for cetrorelix is advancing on course and thrilled to continue my involvement with this novel compound leading its class in development. I believe cetrorelix has a high probability of ultimately providing a convenient, safe and effective treatment for the millions of men suffering from BPH."
This first study, involving approximately 600 patients, is part of an extensive phase 3 programme enrolling a total of about 1,500 patients, which will include other large safety and efficacy studies conducted in North America and Europe.