Spectrum Pharmaceuticals Commences Patient Enrollment in Randomized Phase 2b Clinical Trial of Ozarelix for Hormone-Dependent Prostate Cancer
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.”
Under the Phase 2b clinical protocol, patients will be randomized in a 2:1 ratio to either the ozarelix or goserelin arm, respectively. Eligible patients randomized to the ozarelix arm will receive a loading dose of SC ozarelix, followed by a lower maintenance dose on days 28 and 56. Eligible patients randomized to the goserelin arm will receive SC goserelin at randomization followed by two doses of goserelin on days 28 and 56. All patients will be followed for 84 days. The primary outcome will be to assess the percentage of patients who achieve the level of testosterone <= 0.5 ng/mL from day 28 through day 84. Secondary outcomes include: assessments of the percentage of patients with testosterone surge (“hormone escape”) during the first two weeks of treatment; effects on Prostate Specific Antigen (PSA) levels; and safety of ozarelix SC monthly dosing compared to goserelin depot SC monthly dosing.
The Phase 2b study is being conducted at multiple sites in the United States, as well as in India through Spectrum’s subsidiary, OncoRx.
Prostate cancer accounts for 10-30% of tumors in men and for 13% of male cancer deaths, with peak incidence and peak mortality around 70 years of age. After lung cancer, prostate cancer is the second most common cause of cancer-related death in men. The global prostate cancer market is expected to reach approximately $4.8 billion by 2015. For those patients with prostate cancer who will require permanent androgen deprivation therapy but do not undergo surgical castration (orchiectomy), alternative treatments include endocrine therapy with LHRH analogs (frequently combined with antiandrogens); however, these agents often have limitations, including initial testosterone surge which may exacerbate disease. Newer gonadotropin-releasing hormone (GnRH) antagonists, particularly, LHRH antagonists, have been developed to avoid these limitations and for use as monotherapy to treat prostate cancer.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum currently markets two oncology drugs ─ FUSILEV® (levoleucovorin) for Injection in the U.S. and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights. Spectrum's strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at .