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Positive Results Reported From Phase 2 Dosage Regimen Study for Cetrorelix
QUEBEC CITY, Oct. 7 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; NASDAQ: AEZS) today announced statistically significant positive results from a randomized, double-blind, placebo-controlled Phase II trial designed to evaluate different dosage regimens of a depot formulation of cetrorelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, in 250 patients with symptomatic benign prostatic hyperplasia (BPH). These new data demonstrate a dose-dependent, durable and statistically significant (p less than 0.001) improvement of clinical symptoms characteristic of BPH, including IPSS (International Prostate Symptom Score), at all dosages except the lowest, as well as an excellent safety and tolerability profile. These positive results are consistent with data from earlier studies and provide the basis for further development of cetrorelix in BPH through collaboration with Solvay Pharmaceuticals and Shionogi/Nippon Kayaku.
Benign prostate hyperplasia is characterized by an abnormal, but not malignant, testosterone-mediated growth of prostate tissue. BPH is estimated to affect approximately 33 million men over 60 years of age. In 2004, the amount spent on drug treatment for this condition is expected to be around US$1.8 billion.
"We are very excited about the positive results from this new Phase II trial, the last one from a broad seven-study Phase II program evaluating cetrorelix in a combination of indications, and believe it provides strong evidence for the efficacy and safety of cetrorelix in BPH, endometriosis and myoma," said Prof. Jurgen Engel, Executive Vice President, Global R&D and Chief Operating Officer at AEterna Zentaris. "These results, in our opinion, compare very favorably to currently marketed therapies for BPH, which require daily administration. We look forward to continued advancement of this program by our development and marketing partners worldwide, and the initiation of pivotal programs on cetrorelix, including in BPH."
"The successful completion of this latest trial is a remarkable achievement and confirms the excellent partnership we have built with AEterna Zentaris. We believe that the results of the extensive Phase II program will now allow us to finalize the development plans for the compound," stated Dr. Werner Cautreels, Solvay Pharmaceuticals' Global Head of R&D.
The randomized, double-blind, placebo-controlled trial enrolled patients with symptomatic and objectively defined BPH (decreased urine flow) and was conducted in Europe, under the coordination of Professor Frans MJ Debruyne from the Department of Urology, University Medical Center in Nijmegen. All eligible patients received two intramuscular injections of placebo, two weeks apart, during a run-in period. After the initial four-week run-in period, 250 patients with symptomatic BPH were randomized into five equal groups receiving either placebo injections or four different dosage regimens from 60 to 120 mg in two or three injections of a depot formulation of cetrorelix over the course of four weeks.
Patients were followed for up to 26 weeks after the last injection for efficacy and safety assessments, as well as for levels of testosterone and quality of life and sexual function. As early as one month following the initiation of therapy, the use of cetrorelix was associated with a dose- dependent, statistically significant improvement of clinical signs and symptoms, including IPSS and maximum uroflow, compared to placebo. Importantly, for all dosage regimens the therapeutic response lasted until the last observation point, i.e. 24 to 26 weeks following cessation of cetrorelix administration.
Source: AEterna Zentaris Inc.