Healthcare Industry News:  bladder cancer 

Biopharmaceuticals Oncology Regulatory

 News Release - February 19, 2008

Spectrum Pharmaceuticals Receives Approval from Canadian Authorities to Expand EOquin(R) Registrational, Phase 3 Clinical Trials into Canada

IRVINE, Calif.--(HSMN NewsFeed)--Spectrum Pharmaceuticals, Inc., (Nasdaq:SPPI ) today announced that the Therapeutic Product Directorate of Health Canada has approved the trials to be conducted in Canada by issuing a No Objection Letter to Spectrum’s Clinical Trial Application for EOquin®, the Company’s drug candidate in Phase 3 clinical trials for non-invasive bladder cancer. Phase 3 protocols are open and currently recruiting patients in the United States. This action authorizes the initiation of clinical trials in Canada, where preparations have been underway for several months.

“An investigator’s meeting involving more than 30 urologists and their study coordinators has already been conducted in Toronto, Canada. We expect to begin enrolling patients at these sites soon,” said Rajesh C. Shrotriya, M.D., Chairman, President and CEO of Spectrum Pharmaceuticals. “More than 250 patients have already been enrolled in the United States in the first Phase 3 study, which was opened in May 2007. With the expansion of clinical trials with this large group of Canadian urologists, we expect to increase the rate of accrual in the second study, which was initiated in the U.S. in September 2007.”

The EOquin registration plan calls for two double blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder cancer. Patients are randomized in a one-to-one ratio to EOquin or placebo. The primary endpoint is a statistically significant difference (p<0.05) in the rate of tumor recurrence between the two treatment groups by year two. The first Phase 3 study is currently expected to complete enrollment by end of this year, and the second Phase 3 trial to be fully enrolled by mid 2009.

About EOquin

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 living with bladder cancer. 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 most expensive cancer to treat on a lifetime basis. 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 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, the safety and efficacy of EOquin, that EOquin is expected to carry a low risk of systemic toxicity, that we expect to begin enrolling patients at Canadian sites soon, that with the initiation of this large Canadian group, we expect to increase the rate of accrual in the second study, The first Phase 3 study is currently expected to complete enrollment by end of this year, and the second Phase 3 trial to be fully enrolled by mid 2009, 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, including EOquin, may not receive approval from the FDA or the EMEA, 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.


Source: Spectrum Pharmaceuticals

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