SPECTRUM REACHES SPA AGREEMENT FOR BLADDER CANCER DRUG

Spectrum Pharmaceuticals announced it has reached an agreement with the FDA under the special protocol assessment (SPA) procedure for the company's bladder cancer drug candidate, EOquin. The SPA process allows for an agreement between Spectrum and the FDA on the design of a study, including clinical drug supply, pivotal trial design, clinical endpoints, clinical conduct and data analysis, and is intended to provide assurance that if prespecified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application.

The EOquin SPA calls for two double-blind, placebo-controlled, randomized, Phase III clinical studies, each with 562 patients with Ta G1 G2 noninvasive bladder cancer. The primary endpoint will be a statistically significant difference in the rate of tumor recurrence between the two treatment groups by year two. The company currently anticipates enrollment of the first patients in the U.S. trial in the second quarter of 2007.

EOquin (apaziquone for intravesical instillation) is a drug currently being developed for the treatment of noninvasive bladder cancer, which is a cancer that has invaded the innermost lining of the bladder. Eoquin becomes activated by reductase enzymes found in cancer cells and is formulated for administration directly into the bladder. In a Phase II pilot study for which patient accrual was completed this year, EOquin instilled into the bladder following TUR-BT was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and, therefore, would carry a low risk of entering the rest of the body.