600 Patient Trial Conducted in the United States and Canada
Posted on : Mon, 08 Jan 2007 12:10:00 GMT Author : AETERNA ZENTARIS INC.News Category : PressRelease
QUEBEC CITY, Jan. 8 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) today announced that the Company initiated the first of three studies in its Phase 3 program in benign prostatic hyperplasia (BPH) with its luteinizing hormone-releasing hormone (LHRH) antagonist compound, cetrorelix. The first study of the previously announced Phase 3 program 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, M.D., Professor at NY University School of Medicine, New York. This first study, involving approximately 600 patients, is part of an extensive Phase 3 program enrolling a total of about 1,500 patients, which will include other large safety and efficacy studies conducted in North America and Europe. The primary efficacy endpoint of this first study is absolute change in International Prostate Symptom Score (IPSS) between baseline before beginning treatment and Week 52, while safety endpoints include changes in sexual function as well as BPH symptom progression equal to or more than 4 points and/or acute urinary retention and/or need for BPH related surgery. Other important endpoints consist of plasma levels of testosterone and changes in bone mineral density.
"We are very excited to have initiated the first study of our Phase 3 program with our flagship product candidate, cetrorelix, and look forward to first patient dosing over the next month. We are yet another step closer to bringing cetrorelix to market and not only have the potential to conveniently, safely and effectively treat men who suffer from BPH, but also create tremendous value to our shareholders," stated Gilles Gagnon, President and Chief Executive Officer at AEterna Zentaris.
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