AETERNA ZENTARIS BEGINS TRIALS OF TREATMENT FOR BPH

AEterna Zentaris has initiated the first of three studies in its Phase III program in benign prostatic hyperplasia (BPH) with its luteinizing hormone-releasing hormone antagonist compound, cetrorelix. The first study assess an intermittent dosage regimen of cetrorelix as a potential safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms.

The study, which will enroll approximately 600 patients, is part of an extensive Phase III 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.

In the first multicenter study, patients will enter a four-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on IPSS. Patients will then be allocated to cetrorelix in a double-blind, randomized, placebo-controlled fashion. Patients will be administered an intramuscular injection of cetrorelix at weeks zero, two, 26 and 28 and will be followed up to week 52. Then, in an open-label fashion, patients will be administered an intramuscular injection of cetrorelix at weeks 52, 54, 78 and 80 and will be followed up to week 90.