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news.Aeterna Zentaris has commenced with its flagship product candidate, cetrorelix, the company's lead luteinizing hormone-releasing hormone antagonist, in the second efficacy study of its Phase III program in benign prostatic hyperplasia, a non-cancerous enlargement of the prostate.
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The double-blind, placebo-controlled efficacy study will involve approximately 400 patients, and will assess an intermittent dosage regimen of cetrorelix as a potential safe and tolerable treatment providing prolonged improvement in benign prostatic hyperplasia (BPH)-related signs and symptoms. This Phase III trial, conducted in Europe is part of the company’s Phase III program with cetrorelix being studied in approximately 1,500 patients in North America and Europe in men with symptomatic BPH.
The primary endpoint for the European efficacy study is absolute change in International Prostate Symptom Score between baseline and Week 52. Other efficacy endpoints include additional measures of BPH symptom progression and the need for BPH-related surgery. Safety endpoints include changes in sexual function. Other important endpoints include plasma changes in levels of testosterone, and assessment of other adverse events.
The third study in the Phase III program, a multi-center safety study, expected to commence shortly, is an open-label, single-armed study involving approximately 500 patients in both North America and Europe.
David Mazzo, president and CEO of Aeterna, said: “Based on our new understanding of the multiple processes involved in the development of BPH and its symptoms, cetrorelix may offer a novel therapeutic approach to doctors and patients currently making trade-offs in care.”