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Spectrum Pharmaceuticals Completes Enrollment in EOquin(TM) Multi-Center Phase 2 Trial for Refractory Superficial Bladder Cancer

Posted on: Thursday, 6 January 2005, 09:00 CST

IRVINE, Calif., Jan. 6 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that it has completed enrollment in the phase 2 trial of EOquin(TM) as a single agent in patients with recurrent superficial bladder cancer refractory to at least one prior treatment regimen. The primary objective of the multi-center, open-label, non-randomized phase 2 trial is to evaluate tumor response (the level of anti-tumor activity of EOquin), with time to recurrence and overall safety as the secondary objectives.

Data previously reported from the phase 2 trial confirmed anti-tumor activity against refractory superficial bladder cancer, as evidenced by nineteen of thirty one patients (~61%) showing a complete response (complete disappearance of the tumor as confirmed by biopsy) after receiving six weekly treatments (via instillation into the urinary bladder) with EOquin. Results also demonstrated that EOquin was well-tolerated, with no systemic toxicity, and local toxicity limited to chemical cystitis in one patient, dysuria and hematuria. While follow-up was short, no responding patient had relapsed, confirming the promising response duration observed in a previous phase 1 trial.

"We are pleased with the rapid enrollment of this trial," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "We continue to grow and advance our portfolio of product candidates, and believe that the completion of enrollment in the phase 2 trial represents an important milestone in this regard. The treatment of refractory superficial bladder cancer represents a significant unmet medical need, and we look forward to advancing the potential of EOquin in patients with this disease. We plan to present phase 2 data on EOquin at the European Association of Urologists Congress, to be held in Istanbul, Turkey during March 16-19, 2005."

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing proprietary and generic drug products for various indications. The Company's current proprietary drug products are primarily focused on the treatment of cancer and related disorders. The Company's lead drug, satraplatin, is a phase 3 oral, anti-cancer drug being co-developed with GPC Biotech AG, and has been granted fast-track status by the United States Food and Drug Administration (FDA) for its initial indication, second-line chemotherapy for hormone-refractory prostate cancer. Elsamitrucin, a phase 2 drug, is being studied for its initial indication, refractory non-Hodgkin's lymphoma. EOquin(TM), a phase 2 drug, is being studied in the treatment of superficial bladder cancer. SPI-153 (formerly, D-63153), a phase 2 drug, is a 4th generation LHRH antagonist with the potential to treat hormone-dependent cancers as well as benign proliferative disorders, such as benign prostatic hyperplasia and endometriosis. The Company's Abbreviated New Drug Application for ciprofloxacin, a broad-spectrum antibiotic and the generic version of Bayer Corporation's Cipro(R) tablets, received approval from the FDA in September 2004. Sales of ciprofloxacin began in the fourth quarter 2004 through Lannett Co. , Spectrum's marketing and distribution partner for ciprofloxacin in the United States. In addition, the Company has five Abbreviated New Drug Applications for carboplatin (generic equivalent of Paraplatin(R)), fluconazole (generic equivalent of Diflucan(R)), two ophthalmic products and an injectable product pending at the FDA. For additional information, including SEC filings, visit the Company's web site 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, sales of ciprofloxacin, the growth and advancement of the Company's portfolio, the completion of enrollment as an important milestone, the initial results of EOquin, advancing the potential of EOquin, the success of our oncology drug candidates in their initial indications and future indications, 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 in a timely manner or at all, the possibility that initial results may not be indicative of future results, 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

Spectrum Pharmaceuticals, Inc.

(949) 743-9295

Anna Kazanchyan, M.D.

Spectrum Pharmaceuticals, Inc.

(949) 743-9215

Spectrum Pharmaceuticals, Inc.

CONTACT: Rajesh C. Shrotriya, M.D., CEO and President, +1-949-743-9295,or Anna Kazanchyan, M.D., +1-949-743-9215, both of Spectrum Pharmaceuticals,Inc.

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

Source: PRNewswire-FirstCall

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