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Patient Enrollment Complete for Phase 3 Trial of Satraplatin as Second-Line Chemotherapy in Hormone-Refractory Prostate Cancer
"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.
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 www.spectrumpharm.com or in the Anticancer Programs section of GPC Biotech's website at www.gpc-biotech.com.
Source: Spectrum Pharmaceuticals, Inc.