Spectrum Pharmaceuticals announced results from two double blind, randomized, placebo controlled, Phase 3 clinical trials for apaziquone in low-grade, non-muscle invasive bladder tumors (NMIBC).
The two multi-center trials consisted of single dose intravesical instillation of apaziquone into the bladder in the immediate post-operative period after surgical resection of low-grade NMIBC. Patients were randomized to apaziquone or placebo. Under the protocol, the patients received a single 4mg dose of apaziquone or placebo following TURBT (Trans-Urethral Resection of Bladder Tumor). An analysis of the pooled data showed a statistically significant treatment effect in favor of apaziquone in the primary endpoint of the rate of tumor recurrence at 2 years (P=0.0174) and in a key secondary endpoint, time to recurrence (P= 0.0076).
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.
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