- 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 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.
About Bladder Cancer
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.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit our website at http://www.spectrumpharm.com.
Forward-looking statement -- This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the Company's promising pipeline, that if approved, EOquin may help the many patients suffering from non-invasive bladder cancer, that EOquin is expected to carry a low risk of systemic toxicity, if any, the safety and efficacy of EOquin and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
COMPANY CONTACTS MEDIA CONTACT
Russell Skibsted Susan Neath
SVP & Chief Business Officer Porter Novelli Life Sciences
Manager, Investor Relations
|SOURCE Spectrum Pharmaceuticals, Inc.|
Copyright©2007 PR Newswire.
All rights reserved