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Spectrum Pharmaceuticals Initiates US Clinical Spectrum Pharmaceuticals Initiates U.S. Clinical Trial of Ozarelix (SPI-153) in Patients with Hormone-Dependent Prostate Cancer - Ozalerix is currently in two multicenter trials underway in Europe - one in benign prostate hypertrophy (BPH) and another in hormone dependent prostate cancer - Spectrum now has five drugs in multiple clinical trials, including one in phase III IRVINE, Calif., July 25 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced the launch of a phase I/II trial in the United States to explore the safe and efficacious dose range of ozarelix (formerly SPI-153) as a treatment for patients with hormone- dependent prostate cancer. "We are pleased to advance the development of ozarelix in the United States with the start of this clinical study," stated Rajesh Shrotriya, M.D., Chairman of the Board, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "This study will provide us additional valuable information regarding the optimum dose range for testosterone suppression, an important outcome measure in the management of hormone-dependent prostate cancer." About Prostate Cancer Prostate cancer is the second leading cause of cancer deaths in men and occurs when a malignant tumor forms in the tissue of the prostate. According to figures released by the American Cancer Society, approximately 232,090 new cases and 30,350 deaths will occur in the U.S. during 2005. The initial treatment of prostate cancer included surgery along with radiation therapy and hormonal therapy. About Ozarelix Ozarelix is a fourth generation LHRH (Luteinizing Hormone Releasing Hormone), also known as GnRH (Gonadotropin Releasing Hormone), antagonist. LHRH antagonists have the potential to treat hormone-dependent cancers as well as benign proliferative disorders such as benign prostatic hypertrophy and endometriosis. More information on ozarelix can be found in our annual report on Form 10-K filed with the Securities and Exchange Commission. About Spectrum Pharmaceuticals Spectrum Pharmaceuticals is a specialty pharmaceutical company 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 http://www.spectrumpharm.com. Forward-looking statements 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, this study's ability to provide us additional valuable information regarding the optimum dose range for testosterone suppression, LHRH antagonists' potential to treat hormone-dependent cancers as well as benign proliferative disorders such as benign prostatic hypertrophy and endometriosis 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 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. Contact: Laurie Little Sr. Director, Investor Relations (949) 743-9216 SOURCE Spectrum Pharmaceuticals, Inc. -0- 07/25/2005 /CONTACT: Laurie Little, Sr. Director, Investor Relations, of Spectrum Pharmaceuticals, +1-949-743-9216/ /Web site: http://www.spectrumpharm.com / (SPPI) CO: Spectrum Pharmaceuticals, Inc. ST: California IN: BIO HEA MTC SU: SVY MK -- NYM078 -- 7023 07/25/2005 08:00 EDT http://www.prnewswire.com .
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