Spectrum Pharmaceuticals Initiates Second Registrational Phase 3 Clinical Trial for EOquin(R) in Patients With Non-Invasive Blad...( - First Patient Enrolled in...)

- First Patient Enrolled in Second of Two Phase 3 Trials

- More Than 100 Patients Enrolled in First Phase 3 Trial - Trial Design Was Reviewed Under Special Protocol Assessment Procedure

With The FDA

IRVINE, Calif., Sept. 7 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., (Nasdaq: SPPI) today announced today that it has begun enrolling patients in its second pivotal Phase 3 registrational trial for EOquin, the Company's drug candidate for non-invasive bladder cancer. The trial design was reviewed under a previously announced Special Protocol Assessment procedure, which calls for two double-blind, placebo-controlled, randomized clinical trials.

"The initiation of our second pivotal Phase 3 trial for EOquin in non-invasive bladder cancer patients demonstrates the significant progress we are making with this program," stated Rajesh C. Shrotriya, M.D., Chairman, President and CEO of Spectrum Pharmaceuticals. "Non-invasive bladder cancer is the fifth most common cancer, with a incidence of more than 67 thousand in the U.S. and more than 147 thousand in Europe. Because bladder cancer is typically not lethal, it is estimated that there are more than 500 thousand people suffering from bladder cancer in the United States and more than 935 thousand in Europe. If approved, EOquin may help the many patients suffering from this disease."

The EOquin study calls for two double blind, placebo-controlled, randomized Phase 3 clinical trials, in patients with non-invasive bladder cancer. Patients will be randomized in a one-to-one ratio to EOquin or placebo. The primary endpoint will be the difference in the rate of tumor recurrence between the two treatmen
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