Spectrum Completes Enrollment In Phase 3 Pivotal Trial Of Apaziquone

Spectrum Pharmaceuticals (Spectrum) has reported that one of the two Phase 3 pivotal clinical trials of Apaziquone has achieved its enrollment target, having enrolled approximately 800 patients with non-invasive bladder cancer. The second Phase 3 clinical trial of Apaziquone is expected to complete enrollment by the end of the year.

Reportedly, Apaziquone registration plan, which the FDA concurred with under a Special Protocol Assessment, calls for two double blind, placebo-controlled, randomised Phase 3 clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder cancer. Patients are randomised in a one-to-one ratio to Apaziquone or placebo.

Under the protocol, the patients are given a single 4mg dose following surgical removal of the tumors. The primary endpoint is a statistically difference in the rate of tumor recurrence between the two treatment groups by year two.

Moreover, the company has also received scientific advice from the EMEA, whereby the EMEA agreed that the two Phase 3 studies as designed should be sufficient for a regulatory decision regarding European registration.

Rajesh Shrotriya, president chairman and CEO of Spectrum, said: “This is a particularly important milestone for Spectrum and our clinical sites for their unprecedented and remarkable achievement in completing the enrollment of this study ahead of schedule. In due course, we look forward to evaluating the safety and efficacy of apaziquone in bladder cancer. The ‘fast-track’ designation should further help expedite the drug’s review process with the FDA.”