SPECTRUM BEGINS TRIAL OF OZARELIX IN BPH

Spectrum Pharmaceuticals announced that the first patient has been dosed in the company's Phase IIb U.S. study of ozarelix in patients with benign prostate hypertrophy (BPH). The trial will be conducted in accordance with the protocol recently accepted by the FDA.

The study is a randomized, double-blind, placebo-controlled trial enrolling approximately 100 men suffering from BPH. In this trial, patients will be dosed with 15 mg of ozarelix or placebo on day one and day 15 and will then be followed for six months. The study will evaluate safety and assess the efficacy of ozarelix as a treatment for BPH. The primary endpoint of the study is the improvement of BPH symptoms as measured by the International Prostate Symptom Score. The study will also measure urine flow and quality of life. Data from the study will be used to support a new drug application for ozarelix.

"We are pleased to meet our objective of initiating the Phase IIb trial of ozarelix this month, and we are on track to initiate a Phase III trial in the second half of 2007 to evaluate long-term efficacy and safety of ozarelix courses given at six-month intervals," Rajesh Shrotriya, chairman, president and CEO of Spectrum, said.

Last year Spectrum reported results from a double-blind, randomized, placebo-controlled, multicenter, dose-ranging, Phase II trial with ozarelix in patients suffering from BPH. While the primary efficacy endpoint was achieved at all dosage regimens in this trial and ozarelix was well tolerated, the best results were obtained with the 15 mg dose.

Ozarelix is a fourth-generation luteinizing hormone releasing hormone antagonist administered as an intramuscular injection. Spectrum received an exclusive license from AEterna Zentaris to develop and market ozarelix for all potential indications in North America and India.