AEterna Zentaris: phase 2 trial of ozarelix in prostate cancer meets primary endpoint

By Lisa Kerner

Charlotte, N.C., Aug. 2 - AEterna Zentaris Inc. said its phase 2 trial of the luteinizing hormone releasing hormone antagonist, ozarelix, in patients with hormone-dependent inoperable prostate cancer met its primary endpoint of defining a tolerable dosage regimen that suppresses testosterone at castration level for a three-month test period.

The study also met a secondary efficacy endpoint of reducing serum PSA levels by 50% or more, compared to baseline, according to a news release.

AEterna extended the open-label, randomized-controlled dose-finding trial beyond its original 48 patients to 64 patients.

Four groups of 16 patients received intramuscular dosage regimens of ozarelix (65 mg, 100 mg or 130 mg) according to different dosing schedules and repeated for three cycles of 28 days.

At a dose of 130 mg per cycle, all patients remained suppressed to castration (< 0.5 ng/ml) until at least day 85, with a 97% tumor response as measured by PSA levels.

The company has started an additional study of 32 patients in Europe with its partner Spectrum Pharmaceuticals.

"Now that we have a suitable dosage regimen of ozarelix for the potential treatment of prostate cancer, we are pleased to further advance the clinical development of ozarelix in this indication with a phase 2b program," chief operating officer Jurgen Engel said in the release.

AEterna is a Quebec City, Quebec, biopharmaceutical company focused on oncology and endocrine therapy.

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