Spectrum Initiates Clinical Trial For EOquin In Patients With Non-Invasive Bladder Cancer

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Non-Invasive Bladder Cancer

Spectrum Pharmaceuticals has begun enrolling patients in its second pivotal Phase 3 registrational trial for EOquin - 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."

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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 treatment groups by year two.

EOquin (apaziquone for intravesical instillation) is a drug currently being developed for the treatment of non-invasive bladder cancer, which is a cancer that has invaded the lining of the bladder. EOquin, an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. In a Phase 2 pilot study which was completed earlier this year, EOquin instilled into the bladder following surgery was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and therefore, is expected to carry a low risk of systemic toxicity, if any.

Spectrum Pharmaceuticals completed a multi-center, Phase 2 clinical trial in Europe. The results of the trial showed that EOquin was well-tolerated and produced a 67% CR (complete response) in patients, many of whom had been treated multiple times. The data from this study were presented to the FDA in early 2006.

The American Cancer Society estimates that 67,160 new cases of bladder cancer will be found in the United States. According to Globocan Data estimates, approximately 147,000 new patients will be diagnosed with bladder cancer in Europe during 2007. The American Cancer Society estimates that approximately 13,750 people will die of this disease in the U.S. in 2007. Globocan Data estimates more than 53,000 will die in Europe in 2007. According to these sources, at any given time, it is estimated that there are more than 500,000 patients in the U.S. and more than 935 thousand patients in Europe. Non-invasive bladder cancer accounts for 75 to 80 percent of all cases of bladder cancer at first diagnosis. According to Botteman et al., (PharmacoEconomics 2003), bladder cancer is the fifth most expensive cancer to treat. The initial treatment of this cancer is surgical removal of the tumor. Because of the high frequency of early recurrences of the tumor, patients are usually prescribed additional therapy to prevent or delay such recurrences. This additional therapy generally consists of immunotherapy or chemotherapy drugs instilled directly into the bladder.

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