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Spectrum Pharmaceuticals Launches, Phase 2 Multicenter, Clinical Trial of SPI-153 in Hormone-Dependent Prostate Cancer

Posted on: Monday, 11 April 2005, 09:00 CDT

IRVINE, Calif., April 11 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced the launch of a phase 2 trial to evaluate the safety and efficacy of SPI-153 as a treatment for patients with hormone-dependent prostate cancer.

The multi-center phase 2 trial is designed to evaluate the effects of SPI-153 on hormonal levels, in particular testosterone, as well as objective anti-tumor effects. The trial will be conducted in Europe with the collaboration of AEterna Zentaris Inc. (Nasdaq: AEZS; TSX: AEZ), our licensor of SPI-153 (D-63153).

"We are delighted to see the initiation of this important study for a disease that is the most prevalent cancer among men," stated Rajesh Shrotriya, M.D., Chairman of the Board, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "We believe that our drug may prove to be an important addition in treating this deadly disease. SPI-153 is our third oncology drug in phase 2 trials; the other two drugs being EOquin(TM) for superficial bladder cancer and elsamitrucin for refractory non-Hodgkin's Lymphoma. In addition, our third generation platinum drug satraplatin is currently in phase 3 trials, which are being conducted by our partner GPC Biotech, with the goal of filing an NDA in 2006."

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 SPI-153

SPI-153 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. More information on SPI-153 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 related disorders. 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, SPI-153 as an important addition in treating prostate cancer, LHRH antagonists potential to treat hormone-dependent cancers as well as benign proliferative disorders such as benign prostatic hypertrophy, the extensive research and development capabilities of the Company's strategic alliance partners, the Company's operational flexibility and regulatory proficiency, filing an NDA for satraplatin 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/or 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 and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission.

Contacts:

Rajesh C. Shrotriya, M.D., Laurie Little

CEO and President Director, Investor Relations

(949) 743-9295 (949) 743-9216

Spectrum Pharmaceuticals, Inc.

CONTACT: Rajesh C. Shrotriya, M.D., CEO and President, +1-949-743-9295,or Laurie Little, Director, Investor Relations, +1-949-743-9216, both ofSpectrum Pharmaceuticals, Inc.

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

Source: PRNewswire-FirstCall

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