Spectrum Pharmaceuticals Announces Completion Of Patient Accrual In Its EOquin(R) Pilot Study, Prior To Initiating Phase 3 Studies In The U.S.

Spectrum Pharmaceuticals (Nasdaq: SPPI) announced today that the Company has completed patient accrual in the U.S. pilot safety study of EOquin(R) in patients with noninvasive bladder cancer. In this study, EOquin(R) was found to be well tolerated when administered to patients immediately following surgery for noninvasive bladder cancer in clinical results to date.

The pilot study was a multicenter, single-arm, open-label study. Twenty patients received 4 mg of EOquin(R) in 40 mL of diluent. EOquin(R) was instilled via an indwelling catheter that was then clamped for one hour. After an hour the bladder was drained and the catheter was removed. Patients were assessed for adverse events during the one-hour retention and at follow-up visits on postoperative days eight and 15. Wound healing was assessed by cystoscopy performed at postoperative day 85. In six patients, systemic absorption, if any, was assessed by measuring the blood levels of EOquin(R) and its metabolites. Results confirmed previous clinical results where EOquin(R) administration was well tolerated. In addition, there was no adverse effect on wound healing and when administered immediately after surgery, EOquin(R) was not absorbed into the bloodstream.

"We are pleased with the results of this study, that was requested by the FDA, which demonstrate that EOquin is well tolerated and does not affect surgical wound healing and is not systemically absorbed even when given immediately after surgery; we therefore will not expect side effects outside of the bladder. We look forward to finalizing the Phase 3 protocol, which has been submitted to the FDA for a Special Protocol Assessment. We expect to initiate the Phase 3 studies before mid year," stated Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum Pharmaceuticals. "Bladder cancer is a difficult and expensive disease to treat, and we believe that EOquin(R) has the potential to make a difference in the lives of bladder cancer patients."

Spectrum anticipates full data from the completed pilot study to be presented at a scientific conference in the coming months.

About EOquin(R)

EOquin(R) (apaziquone for intravesical instillation) is a drugВґ currently being developed for the treatment of noninvasive bladder cancer, cancer that has not invaded the muscle of the bladder wall. EOquin(R), an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. In studies performed to date, EOquin(R) was not absorbed in any significant amount from the bladder wall into the bloodstream and would carry a lesser risk of harming the rest of the body.

Spectrum Pharmaceuticals completed multi-center, Phase 2 clinical trials in Europe. The results of the trial were favorable, showing that EOquin(R) was safe and efficacious. These data were presented to the FDA in early 2006.

About Bladder Cancer

The American Cancer Society estimates that there were more than 61,420 new cases of and 13,060 deaths from bladder cancer in 2006 in the United States. The estimated patient population with bladder cancer is over 400,000 in the United States and even greater in Europe. Noninvasive bladder cancer accounts for 75 to 80 percent of all cases of bladder cancer at first diagnosis. According to Botteman et al., (PharmacoEconomics 2003), bladder cancer is the fifth most expensive cancer to treat. The initial treatment of this cancer is surgical removal of the tumor. Because of the high frequency of early recurrences of the tumor, many current practice guidelines recommend immediate instillation of a chemotherapeutic agent after surgery for which there is currently no approved drug in the U.S. During the past 20 years or so, no new drugs have been introduced in the market for treatment of bladder cancer.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum's expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit 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, Spectrum's ability to identify, acquire and develop its portfolio of drug candidates, the Company's promising pipeline, the safety and efficacy of EOquin(R), side effects outside of the bladder, initiation of a Phase 3 study in the first half of this year, that EOquin(R) has the potential to make a difference in the lives of bladder cancer patients, that full data from the completed pilot study will be presented at a scientific conference in the coming months 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, 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 significant revenues, our limited human and financial resources, 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. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

Spectrum Pharmaceuticals
http://www.spectrumpharm.com