Spectrum Pharmaceuticals (NasdaqGM: SPPI) today announced 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.
“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,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “Bladder Cancer is the fifth most common type of cancer, and is the most expensive cancer to treat on a lifetime basis. 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.”