Spectrum completes enrollment in phase 2 ozarelix study for treatment of enlarged prostate

By Angela McDaniels

Seattle, Nov. 21 - Spectrum Pharmaceuticals Inc. said it has achieved complete enrollment for a phase 2 trial of ozarelix in benign prostatic hypertrophy more that four months ahead of schedule.

The multicenter clinical trial is designed to evaluate improvement in urine flow, shrinkage of the prostate volume and various symptoms of the disorder over a period of several months, the company said.

The multicenter, placebo-controlled, randomized trial is being conducted in Europe with AEterna Zentaris Inc., a Quebec-based biopharmaceutical company.

"Noncancerous enlargement of the prostate adversely affects the quality of life, leading to increased frequency of urination and difficulty in passing urine. Because ozarelix is expected to have dual effects by directly shrinking the prostate and through controlled reduction in the amount of testosterone (testosterone fuels the prostate gland), our expectation is 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," said chairman, chief executive officer and president Rajesh C. Shrotriya in a company news release.

According to the National Institutes of Health, benign prostatic hypertrophy affects more than 50% of men over the age of 60 and as many as 90% of men over the age of 70. Treatment options include surgery and medications to reduce the amount of tissue and increase the flow of urine.

Current treatment options are inconvenient, leading to ineffective compliance, and are only effective in roughly half of the patients treated, the company said.

Ozarelix is a luteinizing hormone-releasing hormone, also known as gonadotropin-releasing hormone antagonist. Such antagonists have the potential to treat hormone-dependent cancers and benign proliferative disorders such as endometriosis, the company said.

Spectrum is based in Irvine, Calif., and develops prescription drug products for the treatment of cancer and other unmet medical needs.

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