Spectrum Pharmaceuticals Inc Announces Results Of Apaziquone Phase Three Clinical Trials

Spectrum Pharmaceuticals Inc announced that the two double blind, randomized, placebo controlled, Phase three clinical trials for apaziquone did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at two 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 two 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 three 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 four 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.