Spectrum Announces Completion of Patient Enrollment in Ozarelix Phase II Trial in Patients with Benign Prostatic Hypertrophy
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Spectrum Announces Completion of Patient Enrollment in Ozarelix Phase II Trial in Patients With Benign Prostatic Hypertrophy * Enrollment was completed ahead of schedule by more than four months * This is a multicenter, placebo controlled, randomized study in 144 patients with BPH IRVINE, Calif., Nov 21, 2005 /PRNewswire-FirstCall via COMTEX News Network/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that the Company has achieved complete enrollment for a phase II trial of ozarelix in Benign Prostatic Hypertrophy (BPH), more that four months ahead of schedule. The multi-center clinical trial is designed to evaluate both objective parameters, such as improvement in urine flow and shrinkage of the prostate volume, as well as various symptoms of BPH over a period of several months. The trial is conducted in Europe with the collaboration of AEterna Zentaris Inc. (Nasdaq: AEZS; TSX: AEZ), "We are pleased to report that this multicenter, placebo controlled, randomized, phase II trial that was started only in April this year, has already achieved its goal of enrolling 144 patients, ahead of our projections by more than four months," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President. "Non-cancerous, enlargement of the prostate (BPH) adversely affects the quality of life, leading to increased frequency of urination and difficulty in passing urine. Because ozarelix is expected to have dual effects: (1), by directly shrinking the prostate and (2), through controlled reduction in the amount of testosterone (testosterone fuels the prostate gland), our expectation is that a single injection of ozarelix, repeated every few months, may be able to reduce the size of the prostate as well as accompanying symptoms." About Benign Prostatic Hypertrophy Benign prostatic hypertrophy is a non-cancerous enlargement of the prostate frequently occurring in men over the age of 50. The enlargement can result in the gradual squeezing of the urethra, resulting in increased frequency or difficulty in urinating. Enlargement of the prostate is controlled by testosterone. According to the National Institutes of Health, benign prostatic hypertrophy affects more than 50% of men over the age of 60 and as many as 90% of men over the age of 70. Treatment options for benign prostatic hypertrophy include surgery and medications to reduce the amount of tissue and increase the flow of urine. Current treatment options are inconvenient, leading to ineffective compliance and are only effective in roughly half of the patients treated. 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 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, that ozarelix will have dual effects: (1), by directly shrinking the prostate and (2), through controlled reduction in the amount of testosterone, that a single injection of ozarelix, repeated every few months, will reduce the size of the prostate as well as accompanying symptoms, 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. Laurie Little, Sr. Director, Investor Relations, Spectrum Pharmaceuticals, Inc., +1-949-743-9216 http://www.prnewswire.com.