Spectrum Pharmaceuticals Reaches Special Protocol Assessment Agreement With FDA on Phase 3 Trials for EOquin
* Patient Enrollment to Commence in 2Q07 at More Than 50 United States Sites
IRVINE, Calif., March 13, 2007 -- Spectrum Pharmaceuticals, Inc. today announced that an agreement with the U.S. Food and Drug Administration (FDA) has been reached under the Special Protocol Assessment (SPA) procedure for the Company's non-invasive bladder cancer drug candidate EOquin. The SPA process allows for an agreement between Spectrum Pharmaceuticals and the FDA on the design of a study, including clinical drug supply, pivotal trial design, clinical endpoints, conduct, data analysis, and other clinical trial issues, and is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a New Drug Application (NDA) by the Company for EOquin.
"Bladder cancer is one of the most common cancers in the U.S. and there has not been a new treatment approved by the FDA in over 20 years. We believe the initiation of the Phase 3 trial of EOquin is an important step in bringing a more effective treatment for bladder cancer," stated Rajesh Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We have already selected approximately 50 investigators for the clinical trials in the U.S. and expect to conduct an investigator's meeting on March 30-31, 2007."
The EOquin SPA calls for two double-blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562-patients with Ta G1 G2 non-invasive bladder cancer. The primary endpoint will be a statistically significant difference (p