Spectrum Pharmaceuticals discloses Phase II data for Ozarelix

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Spectrum Pharmaceuticals Inc., a partner of Aeterna Zentaris, announces the release of phase II safety and efficacy data for Ozarelix, its prime drug candidate for the treatment of benign prostatic hypertrophy (BPH).

According to Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, the results of the study indicated that Ozarelix had a significant degree of benefit to those suffering with BPH.

The study itself was a randomized, double-blind, placebo controlled, multi-center, dose-ranging Phase 2 trial. Eligible patients were given Ozarelix intramuscularly. Participants were treated with a placebo for four weeks to establish baseline International Prostate Symptom Score (IPSS) and uroflow values.

Afterwards, 144 patients meeting the inclusion criteria were randomly allocated to one of five treatment groups with Ozarelix dosage regimens of 5 mg on Day 1 + 5 mg on Day 15; 10 mg on Day 1 +10 mg on Day 15; 15 mg on Day 1 + 15 mg on Day 15; or 20 mg on Day 1 only.

The effects developed rapidly, with noticeable activity at four weeks from starting treatment, were maximal at 12-16 weeks, and persisted for the 6-month observation period. At week 12, all Ozarelix-treated groups showed improvement with the greatest improvement in the 15 mg + 15 mg group.

Serious adverse events were reported in four patients but were not considered treatment related. No systemic allergic reactions were seen and the injections were well tolerated.

Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate frequently occurring in men over the age of 50. The enlargement can result in the gradual squeezing of the urethra, resulting in increased frequency or difficulty in urinating.