Healthcare Industry News: apaziquone
News Release - May 2, 2007
Spectrum Pharmaceuticals Initiates Phase 3, Registrational Trials With EOquin(R) in Non-Invasive Bladder CancerThese Trials Are Being Conducted Under SPA (Special Protocol Assessment) from the FDA 55 + Sites in U.S. Selected to Participate in Pivotal Study
IRVINE, Calif., May 2 (HSMN NewsFeed) -- Spectrum Pharmaceuticals, Inc., (Nasdaq: SPPI ) today announced today that it has initiated its pivotal Phase 3 registrational trials for EOquin, the Company's proprietary drug candidate for non-invasive bladder cancer. These Phase 3 trials for EOquin will be conducted under the recently agreed upon Special Protocol Assessment (SPA) between Spectrum and the U.S. Food and Drug Administration (FDA).
"Bladder cancer is the fifth most common cause of cancer death in the U.S. and the most costly cancer to treat per patient because of the disease's characteristic high rate of recurrence," said Mark Soloway MD, Professor and Chairman of the University of Miami School of Medicine, and Principal Investigator of the EOquin Phase 3 trials. "There has been no new treatment approved and marketed for noninvasive bladder cancer in more than 20 years. EOquin is among the most promising new therapies we have observed, with potential to treat this very common, yet difficult-to-treat, cancer."
The EOquin SPA calls for two double blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562 patients with Ta G1 G2 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. More than 55 centers are currently participating in Phase 3 testing of EOquin. Additional centers will be added as the EOquin trials progress.
"We are encouraged by the SPA we negotiated with the FDA, and we intend to work closely with the agency throughout the duration of the Phase 3 studies for EOquin. We believe that by gaining clarity about the primary and secondary endpoints for the Phase 3 studies with EOquin, we will be able to use the data we generate as the basis of a New Drug Application," said Rajesh C. Shrotriya, Spectrum's Chairman, President and Chief Executive Officer. "In addition, the advancement of EOquin into Phase 3 testing further validates our team's ability to select and develop promising drug candidates."
Additional information regarding the design, enrollment criteria, and participating centers for the Phase 3 trials with EOquin in non-invasive bladder cancer, is available at www.clinicaltrials.gov (keyword: 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 inner most 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 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 systemic toxicity.
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, and approximately 180,000 in Europe, during 2007. In 2007 about 13,750 people will die of this disease in the U.S. At any given time, it is estimated that there are more than 400,000 patients in the U.S. and more than one million 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. During the past 20 years or so, no new drugs have been introduced in the market for treatment of bladder cancer.
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. Spectrum's expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and reduced-risk methods of commercialization. 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, our team's ability to identify promising drugs and move these drugs through development and toward commercialization, that EOquin is among the most promising new therapies we have observed with potential to treat non-invasive bladder cancer, that additional centers will be added as the EOquin trials progress, that we will be able to use the data we generate as the basis of a New Drug Application for EOquin, 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.
Source: Spectrum Pharmaceuticals
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