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.”

Fast Track designation is designed to facilitate drug development and expedite the review of drugs intended to treat serious conditions and demonstrate the potential to address unmet medical needs. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication facilitates the sponsor’s ability to expeditiously address questions and issues. A drug that receives Fast Track designation is eligible for a Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

The apaziquone registration plan, which the U.S. Food and Drug Administration (FDA) concurred with under a Special Protocol Assessment, calls for two double blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder cancer. Patients are randomized in a one-to-one ratio to apaziquone or placebo. Under the protocol, the patients are given a single 4 mg dose following surgical removal of the tumors. The primary endpoint is a statistically significant difference (p<0.05) in the rate of tumor recurrence between the two treatment groups by year two. Spectrum also received scientific advice from the European Medicines Agency (EMEA) whereby the EMEA agreed that the two Phase 3 studies as designed should be sufficient for a regulatory decision regarding European registration.

Source
Spectrum Pharmaceuticals

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