Ozarelix Phase 2 Data Presented at 29th Congress of the Societe Internationale ...( - In Patients With BPH Clinical Bene...),Health

- In Patients With BPH, Clinical Benefit After Ozarelix Was Maintained For

Up To Six Months - Pivotal Trials Expected To Commence Before Year End Or Soon Thereafter

IRVINE, Calif., Sept. 5 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., (Nasdaq: SPPI) today presented updated Phase 2 safety and efficacy data for ozarelix, the Company's drug candidate for the treatment of benign prostatic hypertrophy (BPH), at the 29th Congress of the Societe Internationale d'Urologie in Paris, France.

"The results of this Phase 2 study demonstrate that the effects of a single dosing regimen consisting of two injections on day one and fifteen are maintained for up to six months, which is superior to what is usually seen with currently approved drugs for BPH," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "A second 78-patient U.S. Phase 2b study, in which duration of follow-up is 9 months, completed enrollment in May. We look to the Phase 2b data to verify and expand on the experience from the Phase 2 study presented today. We continue to 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.

Eligible patients entered a 4-week, single blind, placebo run-in to establish baseline IPSS and urine-flow values. Patients (N=144) meeting the inclusion criteria were randomly allocated and received an IM injec
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