Spectrum Pharmaceuticals Announces Presentation of Clinical Data on EOquin(TM) at the American Association of Cancer Research-National Cancer Institute-European Organization for the Research and Treatment of Cancer (AACR-NCI-EORTC) Meeting in Boston
The data is being presented by investigators from the Cancer Research Unit, Tom Connors Cancer Research Center, University of Bradford, Bradford UK and affiliated institutions. Among the data points reported was that complete responses were seen in five of the seven patients treated with EOquin. The responses in the five patients were confirmed by pathologic examination, and patients were followed to determine the duration of remission. So far, all five responders remain in remission, with two patients having remained disease free for over 12 months. All patients in the study had been previously treated with at least one prior regimen.
The key conclusions presented were:
* The results of this preliminary study suggest that EOquin has marked activity against superficial bladder cancer. * 5 out of 7 patients showed a complete response, defined as compete eradication of tumor at the macroscopic and microscopic level. * Complete responses were confirmed by pathologic examination. * Two patients remain disease free more than 12 months after treatment. * All patients tolerated a dose escalation up to 4 mg/40 ml. * Two patients experienced local toxicity at 8 mg/40 ml, which was reversible. * A dose of 4 mg/40 ml administered weekly for 6 weeks was tolerated well. * No systemic toxicity observed. * No systemic absorption of the drug was observed.
"In a study that was primarily designed to measure safety and identify the maximum tolerated dose, we are very excited that what we believe to be positive signs of clinical activity were also observed." stated Luigi Lenaz, M.D., President of the oncology division of Spectrum Pharmaceuticals. "We are particularly encouraged by the durability of the responses induced by EOquin in a patient population that had failed prior chemotherapy."
The phase 1 study of EOquin 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 results of the phase 1 study, Spectrum announced the launch of a phase 2 study of EOquin in bladder cancer on November 17, 2003.
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 that relate to the anticipated clinical performance of EOquin, and 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 the possibility that EOquin and our other existing drug product candidates may not prove to be safe or effective, our lack of revenues and need for additional financing, 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.