IRVINE, Calif., May 23, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., today announced Phase 2 safety and efficacy data for ozarelix, the Company's drug candidate for the treatment of benign prostatic hypertrophy (BPH), at the American Urology Association Annual Meeting held at the Anaheim Convention Center in Anaheim, California on Tuesday, May 22, 2007.
"The results of this study indicate a significant and sustained degree of benefit, higher than what is usually seen with current treatments of BPH," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We have recently completed enrollment in a Phase 2b study in the U.S. Once we have preliminary results from this Phase 2b trial, we plan to begin a Phase 3 trial, which we expect to begin later this year. Results from the Phase 2b trial will aid in the design of the Phase 3 trial. We believe that ozarelix could help serve the large unmet medical need for more effective BPH treatments."
The efficacy and safety of ozarelix, a GnRH antagonist, given intramuscularly (IM) was assessed in men with moderate to severe Lower Urinary Tract Symptoms (LUTS) due to BPH in a randomized, double-blind, placebo- controlled, multi-center, Phase 2 dose-ranging study.
Patients (N=144) meeting the inclusion criteria were randomly allocated to one of five treatment groups:
Group 1: placebo, Group 2: 5mg ozarelix on Day 1 + 5mg ozarelix on Day 15; Group 3: 10mg ozarelix on Day 1 +10mg ozarelix on Day 15; Group 4: 15mg ozarelix on Day 1 + 15mg ozarelix on Day 15; and, Group 5: 20mg ozarelix on Day 1 only.
Study participants were followed for six months. The primary
efficacy endpoint was a change in the International Prostate
Symposium Score (IPS