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.
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