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Spectrum Announces Completion of Patient Enrollment in Ozarelix Phase II Trial in Patients With Hormone Dependent Prostate Cancer

Posted on: Monday, 29 August 2005, 09:00 CDT

IRVINE, Calif., Aug. 29 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that the Company has achieved complete enrollment for a phase II trial of ozarelix in hormone dependent prostate cancer ahead of schedule by more than four months. The multicenter phase II trial is designed to evaluate the effects of ozarelix on hormonal levels, in particular testosterone, as well as objective anti-tumor effects. The open label trial involving 48 patients is being conducted in Europe with the collaboration of AEterna Zentaris (Nasdaq: AEZS; TSX: AEZ) our licensor of ozarelix.

"We are very pleased that patient enrollment for this phase II trial of ozarelix was completed well ahead of our planned schedule and without reports of allergic reactions so far, a common side effect of other drugs in this class," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President. "We have been impressed with the rate of enrollment in this trial and feel that this has been the result of the strong collaboration between our partner, AEterna Zentaris, and Spectrum. With enrollment now complete, we plan on reporting full results in early 2006 and plan to submit abstracts of this data to several significant scientific meetings in 2006."

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, LHRH antagonists' potential to treat hormone-dependent cancers as well as benign proliferative disorders such as benign prostatic hypertrophy and endometriosis, reporting full results in early 2006 and submitting abstracts of this data to several significant scientific meetings in 2006 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 may not be indicative of future results including the side effects of ozarelix, 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.

Contacts: Laurie Little Sr. Director, Investor Relations (949) 743-9216

Spectrum Pharmaceuticals, Inc.

CONTACT: Laurie Little, Sr. Director, Investor Relations of SpectrumPharmaceuticals, Inc., +1-949-743-9216

Web site: http://www.spectrumpharm.com/

Source: PRNewswire-FirstCall

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