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 that the two double blind, randomized, placebo controlled, Phase 3 clinical trials for apaziquone did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at 2 years between the two arms. However, analysis of the pooled data from both studies showed a statistically significant treatment effect in favor of apaziquone in the primary endpoint of the rate of tumor recurrence at 2 years (p-value = 0.0174) and in a key secondary endpoint, time to recurrence (p-value = 0.0076). The company is considering to request a meeting with the FDA to discuss future steps.
Apaziquone is a novel anticancer drug that is activated, to become a cytotoxic alkylating agent, by bio-reductive enzymes, such as DT-diaphorase, that are over-expressed in bladder cancer cells. Spectrum conducted two multi-center, Phase 3 trials of single dose intravesical instillation of apaziquone into the bladder in the immediate post-operative period after surgical resection of low-grade, non-muscle invasive bladder tumors (NMIBC). Patients were randomized to apaziquone or placebo. Under the protocol, the patients received a single 4 mg dose of apaziquone or placebo following TURBT (Trans-Urethral Resection of Bladder Tumor).
No drugs have been approved and marketed in the US for more than 20 years for low-grade NMIBC.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV®(levoleucovorin) for Injection and ZEVALIN®(ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, apaziquone and belinostat, in late stage development. The Company also has a diversified pipeline of novel drug candidates. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com
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