Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.AEterna Zentaris has completed enrollment of 144 patients for a phase II trial with its investigational drug ozarelix in benign prostatic hyperplasia. The company can now move the trial into the clinical testing phase.
Subscribe to our email newsletter
The randomized, placebo controlled multi-center clinical trial is designed to evaluate both objective parameters, such as improvement in urine flow and shrinkage of the prostate volume, as well as various symptoms of benign prostatic hyperplasia (BPH) over a period of several months.
The trial is being conducted in Europe with the collaboration of Spectrum Pharmaceuticals and results are expected to be disclosed during the second half of 2006.
Benign prostatic hyperplasia has marked adverse symptoms such as increased frequency of urination and difficulty in passing urine. Because ozarelix is expected to have dual effects, by first directly shrinking the prostate and second, through controlled reduction in the amount of testosterone (testosterone fuels the prostate gland), it is hoped that a single injection of ozarelix, repeated every few months, may be able to reduce the size of the prostate as well as accompanying symptoms.
“The swift patient enrollment in both prostate cancer and BPH trials reinforce the confidence of our investigators in the potential benefit of ozarelix, the second lead product in our luteinizing hormone releasing hormone antagonist therapeutic approach,” stated Gilles Gagnon, AEterna Zentaris president and CEO.