IRVINE, Calif., Dec. 5 /PRNewswire-FirstCall/ — Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) today announced the achievement of target enrollment in the Phase 3 registrational trial of its lead drug candidate satraplatin, the only orally bioavailable platinum-based compound in advanced clinical development. The SPARC trial (Satraplatin and Prednisone Against Refractory Cancer) managed by the Company’s co-development partner, GPC Biotech AG (Frankfurt Stock Exchange: GPC; Nasdaq: GPCB), is a multicenter, multinational, double blind, randomized study that is assessing the safety and efficacy of satraplatin in combination with prednisone as a second-line chemotherapy in patients with hormone-refractory prostate cancer (HRPC). More than 200 clinical sites in fifteen countries on four continents have now achieved the goal of accruing 912 patients to the SPARC trial. A number of additional patients are in screening, and GPC Biotech will allow those patients to complete the process and either be randomized into the trial or disqualified, in accordance with the trial protocol.
“We are excited to have achieved this major milestone in the development of satraplatin,” stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President. “The rapid accrual rate of the SPARC trial supports the need for effective second-line chemotherapy treatments for hormone- refractory prostate cancer patients. Working in conjunction with our partner, GPC Biotech, we are committed to completing this study and moving forward in the registration process as expeditiously as possible.
“That we could achieve our accrual goal of 912 patients in just over 26 months, making the SPARC trial one of the fastest accrued Phase 3 clinical trials for chemotherapy drugs in prostate cancer, is a direct testament to the dedication and hard work of the clinical investigators, the study site personnel and the drug development team at GPC Biotech,” continued Shrotriya. “The joint development team, made up of representatives from Spectrum and GPC Biotech, has been looking forward to this day and are pleased to be one step closer towards bringing this important drug to marketing approval and helping patients with this terrible disease.”
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and Europe. Approximately 232,000 men in the U.S. are expected to be diagnosed with the disease in 2005. With over 30,000 U.S. deaths estimated for 2005, prostate cancer is the second leading cause of cancer-related death in men — second only to lung cancer. In the European Union, 138,000 new cases are expected to be diagnosed, and 45,000 patients to die within the same time period. Since the incidence of prostate cancer increases with age, the aging of the overall population is expected to further increase the number of prostate cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery or radiation therapy, and some of these patients are cured. For many others, though, the disease recurs. At this point, the recurrent disease is treated with hormone therapy, and most patients initially respond well to this treatment. Eventually, however, the tumor cells become resistant to the hormones — or “hormone-refractory” — and the tumor again progresses. Increasingly, chemotherapy is being used as an effective first-line treatment for HRPC. However, it is not a cure, and so this is creating a need for effective therapeutic options as second-line chemotherapy treatments for these patients once they have progressed.
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Worldwide sales of these drugs exceeded $2.2 billion in 2004. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. Satraplatin is in a Phase 3 registrational trial — the SPARC trial — as a second-line chemotherapy treatment for HRPC. GPC Biotech has completed a Special Protocol Assessment with the U.S. FDA and has received a Scientific Advice letter from the European regulatory authority, the European Medicines Agency (EMEA). The FDA has also granted fast track designation to satraplatin for this indication.
Phase 2 trials have been completed in HRPC, ovarian cancer and small cell lung cancer. Promising early clinical results have also been shown when satraplatin is combined with radiation therapy, and a Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. Several others studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned. Further information on satraplatin can be found at the Company’s website at http://www.spectrumpharm.com/ or in the Anticancer Programs section of GPC Biotech’s website at http://www.gpc-biotech.com/.
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, completing the Phase 3 study and moving forward in the registration process as expeditiously as possible, bringing satraplatin to marketing approval, key advantages of an oral platinum drug, including ease of administration and patient convenience, in a variety of applications, initiating studies evaluating satraplatin in combination with other therapies and in various cancers 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 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.
Contact: Laurie Little
Sr. Director, Investor Relations
(949) 743-9216
Website: http://www.spectrumpharm.com/
Website: http://www.gpc-biotech.com/
