IRVINE, Calif., April 13 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. announced the presentation of new preclinical data on Apaziquone at the 97th Annual Meeting of the American Association for Cancer Research (AACR) in Washington, DC, earlier this month.
A poster entitled "Analysis of NAD(P)H: quinine oxidoreductase-1 (NQO1), Cytochrome P450 Oxidoreductase (P450R) and glucose transporter 1 (Glut-1) protein expression suggests a possible role for E09 in the treatment of invasive bladder cancer" (Abstract # 546, authors Roger M. Phillips and colleagues from the Institute of Cancer Therapeutics, Bradford, UK and Spectrum Pharmaceuticals) showed the relationship between the expression of biomarkers Glut-1, NQO1 and P450R to tumor grade and stage.
The study found that invasive bladder cancer has significantly lower levels of NQO1 and higher levels of Glut-1, a marker for reduced oxygen tension (hypoxia). Many tumors grow under conditions of hypoxia. This makes them insensitive or resistant to treatment by X-rays. EO9 is activated in tumor cells both in normal oxygenation and in hypoxia. Data from the present study suggests that E09 can be used in combination with radiation as a hypoxic selective therapy for the treatment of invasive bladder cancer.
"We already have exciting data on EOquin(TM) for the treatment of superficial bladder cancer," commented Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum. "This study suggests that Apaziquone may also have anti-tumor activity in hypoxic tumors, such as invasive bladder cancer."
EOquin(TM) (Apaziquone, E09) is an anti-cancer agent formulated for administration directly into the urinary bladder. It is activated by certain enzymes present in higher amounts in cancer cells than in normal cells. Spectrum has proprietary worldwide rights to EOquin(TM) and plans to out-license it for markets outside the U.S., including Europe and Japan.
The American Cancer Society estimates there will be more than 61,420 new cases of and 13,060 deaths from bladder cancer in 2006 in the United States. There is an estimated 400,000 patient population currently in the U.S. and an even greater number estimated in Europe. Approximately 25% of all new patients have muscle-invasive bladder cancer at the time of diagnosis. Of the remaining 75% who initially present with superficial disease, 10%-15% will progress to invasive disease.
The initial treatment for superficial bladder cancer is usually surgical removal of the tumor(s), often followed by additional immunotherapy or chemotherapy drugs instilled directly in the bladder to prevent or delay recurrences. Treatment for invasive bladder cancer involves radical cystectomy (removal of the bladder) with or without radiation therapy and systemic chemotherapy. Radical cystectomy is a major surgery, associated with significant morbidity, and a mortality rate of 1-3%. Radiation therapy is an effective treatment for a number of tumors. Half of all cancer patients will receive radiation therapy during their course of treatment for cancer. While radiation therapy is one of the most widely used treatment modalities, many tumors are hypoxic, and most contain hypoxic areas, which are resistant to radiation therapy. There remains a need to improve the cure rate by radiation therapy, especially in hypoxic tumors.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals, Inc. is a specialty pharmaceutical company based in Irvine, California, 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 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, the Company's operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company's strategic alliance partners, E09's potential to be used in combination with radiation as a hypoxic selective therapy for the treatment of invasive bladder cancer, Apaziquone's anti-tumor activity in hypoxic tumors, EOquin's effectiveness in treating superficial bladder cancer 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 will 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 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, 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.
Contacts: Rajesh C. Shrotriya, M.D. Jeanie D. Herbert Chairman, CEO and President Investor Relations Spectrum Pharmaceuticals, Inc. (949) 743-9216 (949) 743-9295
Spectrum Pharmaceuticals, Inc.CONTACT: Rajesh C. Shrotriya, M.D., Chairman, CEO and President,+1-949-743-9295, or Investor Relations, Jeanie D. Herbert, +1-949-743-9216,both of Spectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
