Healthcare Industry News: bladder cancer
News Release - April 6, 2006
Spectrum Pharmaceuticals Announces Presentation of EOquin(TM) Phase 2 Data at the 21st European Association of Urology Annual Congress in Paris, FranceEnd of Phase 2 and pre-IND meeting held with the FDA
A Phase 3 study is expected to be initiated after a twenty patient pilot study is completed later this year
IRVINE, Calif., April 6 (HSMN NewsFeed) -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI ) today announced that results of a Phase 2 marker lesion study of EOquin(TM) by intravesical instillation in superficial bladder cancer are being presented today at the 21st European Association of Urology Annual Congress in Paris, France by Dr. Antoine G. van der Heijden from the Department of Urology, University Medical Centre Nijmegen, the Netherlands.
A total of 46 patients with multiple lesions of superficial bladder cancer were entered into this multicenter study. After surgical removal of all except one "marker" lesion, patients received six weekly instillations of EOquin(TM) into the bladder. Complete disappearance of the tumor was histologically documented in 30 patients. The data indicates that EOquin(TM) by intravesical instillation demonstrates significant anti-tumor activity in superficial bladder cancer and is well tolerated in patients.
EOquin(TM) is the tradename for apaziquone, a potential anti-cancer agent, formulated for administration directly into the urinary bladder. It is activated by certain enzymes present in higher amounts in cancer cells than in normal cells.
The American Cancer Society estimates there will be more than 61,420 new cases of and 13,060 deaths from bladder cancer in 2006 in the United States. There is an estimated 400,000 patient population currently in the U.S. and an even greater number estimated in Europe. Superficial bladder cancer accounts for 75 to 85 percent of all cases of bladder cancer at first diagnosis. The initial treatment is usually surgical removal of the tumor(s), often followed by additional immunotherapy or chemotherapy drugs instilled directly in the bladder to prevent or delay recurrences.
"We continue to believe that the treatment of refractory superficial bladder cancer represents a significant unmet medical need," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "In fact, no new drugs have been marketed for treatment of superficial bladder cancer in more than 20 years. This latest study definitively confirms that EOquin(TM) has meaningful anti-tumor activity against this cancer and is well tolerated by the patients. After a successful 'end of Phase 2 and pre-IND' meeting with the FDA held earlier this year, we are now planning to initiate a small pilot study, which should be followed by a randomized Phase 3 trial before the end of this year."
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals, Inc. is a specialty pharmaceutical company based in Irvine, California, engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. For more information, please visit our website at www.spectrumpharm.com.
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, the Company's operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company's strategic alliance partners, that the treatment of refractory superficial bladder cancer will represent a significant unmet medical need, the safety and efficacy of EOquinä in treating superficial bladder cancer, initiating a small pilot study and then a randomized Phase 3 trial before the end of this year 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 past results will not be indicative of future results, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, 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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