Spectrum Pharmaceuticals Launches Phase 2 Study of EOquin(TM) in Bladder Cancer
Study to Be Conducted at up to 10 European Hospitals in Patients With Superficial Bladder Cancer
IRVINE, CA--(MARKET WIRE)--Nov 17, 2003 -- Spectrum Pharmaceuticals, Inc. (NasdaqSC:SPPI) today announced the launch of a phase 2 study of EOquin in patients with superficial bladder cancer.
An investigators meeting is being held today in Amsterdam, and up to ten sites in the Netherlands and the United Kingdom will participate in the study. The study is expected to be completed by the end of 2004. The principal investigators are from Bradford University in the United Kingdom and the University of Nijemegen in the Netherlands.
"We look forward to treating the first patient this month in the phase 2 study of EOquin, and hope that this study will build upon the favorable results seen in the recently completed phase 1 study," stated Luigi Lenaz, M.D., President of the Oncology Division of Spectrum Pharmaceuticals. "Data from the phase 1 study supporting our decision to move into phase 2 will be presented at the AACR-NCI-EORTC (American Association for Cancer Research-National Cancer Institute -- European Organization for Research and Treatment of Cancer) conference in Boston later this week."
The phase 1 study of EOquin in bladder cancer was initiated based on peer-reviewed findings by researchers at the University of Bradford. These findings were reported in the British Journal of Cancer in November 2000. The first phase of this study was designed to test the drug's safety and tolerability, and to determine the appropriate dose for subsequent studies. Patients were given six doses of Eoquin over a six-week period, at increasingly higher dose levels each week. Based on the data from this study, the Company has chosen the dose level and decided to expand the number of sites and move into phase 2.
Spectrum Pharmaceuticals' primary focus is to develop in-licensed drugs for the treatment and supportive care of cancer patients. The Company's lead drug, satraplatin, is a phase 3 oral, anti-cancer drug being co-developed with GPC Biotech AG, which has been granted fast-track status by the United States Food and Drug Administration. Elsamitrucin, a phase 2 drug, will initially target non-Hodgkin's lymphoma. Eoquin™ is being studied in the treatment of superficial bladder cancer, and may have applications as a radiation sensitizer. The Company is actively working to develop, seek approval for and oversee the marketing of generic drugs in the U.S. Spectrum also has a pipeline of pre-clinical neurological drug candidates for disorders such as attention-deficit hyperactivity disorder, schizophrenia, mild cognitive impairment and pain, which it is actively seeking to out-license or co-develop. For additional information about the Company, visit the Company's web site at www.spectrumpharm.com.
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 regarding our plans for clinical trials and any other statements that relate to the intent, belief, plans or expectations of the company or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include our lack of revenues and need for additional financing, the possibility that our existing drug product candidates may not prove to be safe or effective, our limited experience in establishing strategic alliances, our limited experience with the generic drug industry and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission.
For further information, please contact:
CEO and President
Spectrum Pharmaceuticals, Inc.
(949) 788-6700, ext. 295