IRVINE, Calif., March 14 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. announced today the filing, with the US Food and Drug Administration, of an investigational new drug (IND) application for EOquin(TM) for use in superficial bladder cancer. EOquin(TM) has previously undergone a number of clinical studies in Europe, including a successful phase 2, marker lesion study, which showed good tolerance and a durable, high complete response rate (67%).
A successful pre-IND and end of Phase 2 meeting with the FDA, in January 2006, in which the development strategy, including the phase 3 design and objectives, were discussed, preceded this IND filing. The US clinical study program will initiate with a small pilot study of EOquin(TM) given in an adjuvant setting, after transurethral resection, and will continue with a randomized controlled phase 3 study.
"We are delighted to move EOquin(TM) towards registration", said Rajesh C Shrotriya MD, President, Chief Executive officer and Chairman of the Board of Spectrum. "We are pleased to have reached a consensus with the FDA, and plan to initiate a pilot study as soon as the IND is approved. We also plan to request a Special Protocol Assessment for the registrational phase 3 study, and expect to commence the phase 3 clinical study in the second half of the year. In parallel with the US clinical study program, we are planning to meet with European Health Authorities to discuss our development plans in Europe. We are also discussing a phase 3 study with the Urology Group of the European Organization for the Research and Treatment of Cancer, the premier European oncology cooperative group."
About EOquin(TM):
EOquin is an anti-cancer agent that becomes activated by certain enzymes present in higher amounts in cancer cells than in normal cells. It is currently being developed for the treatment of recurrent superficial bladder cancer, which is cancer that has not invaded the muscle of the bladder wall. EOquin(TM) is the trademarked name for the substance apaziquone formulated for administration directly into the urinary bladder ("intravesical instillation").
The American Cancer Society estimates that there will be 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. Superficial 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, patients are usually prescribed additional therapy to prevent or delay such recurrences. This additional therapy generally consists of immunotherapy or chemotherapy drugs instilled directly into the bladder. During the past 20 years or so, no new drugs have been introduced in the market for treatment of bladder cancer.
EOquin(TM) is activated to a greater degree within tumor cells than in the normal bladder lining. Also, it is not absorbed in any significant amount from the bladder wall into the bloodstream and thus carries a lesser risk of harming the rest of the body. During 2005, we completed a multi-center phase II clinical trial to evaluate the level of anti-tumor activity of EOquin(TM) as well as the safety of treatment. These results were discussed with the FDA.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a specialty pharmaceutical company 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 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, the Company's operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company's strategic alliance partners, that EOquin is advancing toward registration, that EOquin(TM) shows good tolerance and a durable, high complete response rate, that we will initiate a Phase 3 study of EOquin(TM) in 2006, that we will initiate a small pilot study of EOquin(TM) given in an adjuvant setting, after transurethral resection, that we will request a Special Protocol Assessment for the registrational phase 3 study, that we will meet with European Health Authorities to discuss our development plans in Europe, EOquin's(TM) efficacy in the treatment of recurrent superficial bladder cancer, that EOquin(TM) is not absorbed in any significant amount from the bladder wall into the bloodstream and thus carries a lesser risk of harming the rest of the body, that we will conduct a phase 3 study with the Urology Group of the European Organization for the Research and Treatment of 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, that past 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 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.
Contacts: Rajesh C. Shrotriya, M.D., CEO and President Spectrum Pharmaceuticals, Inc. (949) 743-9295
Spectrum Pharmaceuticals, Inc.CONTACT: Rajesh C. Shrotriya, M.D., CEO and President of SpectrumPharmaceuticals, Inc., +1-949-743-9295
Web site: http://www.spectrumpharm.com//
