Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in hematology and oncology, today announced initiation of
patient enrollment in the second part of the Company's randomized Phase
2 clinical program of ozarelix, a luteinizing hormone-releasing hormone
(LHRH) antagonist, in men with prostate cancer for whom hormonal
treatment is indicated. The objective of the international,
multi-center, randomized, open-label study is to assess the safety and
efficacy of a monthly dosing regimen of ozarelix administered
subcutaneously (SC) versus ZOLADEX® (goserelin acetate) depot. The
Company will enroll an additional 150 patients in Part 2 of the clinical
program.
"We are pleased to announce the commencement of our Phase 2b ozarelix
study, which we believe increases the likelihood of demonstrating
clinically compelling activity while potentially avoiding limitations
associated with other endocrine therapies," stated Rajesh C. Shrotriya,
M.D., Chairman, President and Chief Executive Officer of Spectrum
Pharmaceuticals, Inc. "We believe this compound has great promise in
prostate cancer, the second leading cause of cancer death in men, for
which there continues to be a significant medical need for therapeutic
innovation. Based on the proven mechanism of action and encouraging
results from the first part of the clinical program, we are excited
about the potential of ozarelix."