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Spectrum Pharmaceuticals Launches Multi-Center, Phase 2 Clinical Trial of SPI-153 in Benign Prostatic Hypertrophy

Posted on: Wednesday, 13 April 2005, 09:00 CDT

IRVINE, Calif., April 13 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced the launch of a multi-center phase 2 clinical trial to evaluate the safety and efficacy of SPI-153 as a treatment for patients with benign prostatic hypertrophy (BPH).

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 will be conducted in Europe with the collaboration of AEterna Zentaris Inc. (Nasdaq: AEZS; TSX: AEZ), the parent of our licensor of SPI-153 (D-63153).

"We are eager to pursue our studies of SPI-153 as an option for patients with BPH, a disease that represents a significant challenge to their quality of life," stated Rajesh Shrotriya, M.D., Chairman of the Board, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "Previous studies have shown a dose-dependant testosterone suppression, leading us to believe that SPI-153 has the potential to reduce both the prostate size and corresponding symptoms, diminishing the impact of this prevalent health problem."

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 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.

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, SPI-153's potential to reduce both prostate size and corresponding symptoms of BPH, LHRH antangonists' potential to treat hormone-dependent cancers as well as benign proliferative disorders such as BPH, the Company's operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company's strategic alliance partners, 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 authorities, 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 oncology 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.,

CEO and President

(949) 743-9295

Laurie Little

Director, Investor Relations

(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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