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Phase 2 Study Initiated for Satraplatin in Patients With Metastatic Breast Cancer
The Phase 2 study in metastatic breast cancer is an open label, multicenter study being managed by US Oncology, a leading healthcare services network dedicated exclusively to cancer treatment and research. Fifty-seven research sites in the US Oncology Network plan to participate in this trial. The primary objective of this study is to determine the objective response rate of satraplatin in this patient population. The study is expected to enroll 80 patients.
"Our partnership with GPC Biotech enables us to advance the development of satraplatin, while also minimizing our expenses and preserving the upside associated with this promising drug for our company and our shareholders," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President. "While enrollment in the phase 3 trial in hormone refractory prostate cancer is on target for completion by the end of the year, the initiation of additional, exploratory studies evaluating satraplatin in additional indications is another step towards realizing the potential this drug might have on the treatment of cancer."
"Despite advancements in treating breast cancer, it is important to continue to find and develop effective therapies, as patients with advanced disease often do not respond to existing treatments or will eventually relapse," said Joyce O'Shaughnessy, M.D., Co-Director of US Oncology's Breast Cancer Research Committee and Director, Breast Cancer Prevention at Baylor- Charles A. Sammons Cancer Center in Dallas, Texas. "Satraplatin, as an oral drug that is relatively well tolerated, could provide an additional option for these patients. I look forward to exploring the compound's potential in this disease setting."
Breast cancer is the second leading cause of cancer-related death among women in the US and in Europe, behind lung cancer, according to the American Cancer Society. In 2005, it is estimated that over 210,000 new cases of invasive breast cancer will be diagnosed and over 40,000 women are expected to die from the disease in the U.S. The numbers are even higher in the European Union, with an estimated 270,000 new cases of the disease diagnosed annually and 88,000 deaths. While today in the U.S. the 5-year relative survival rate for localized breast cancer is 98%, the figure for patients with distant metastases is only 26%.
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 hormone-refractory prostate cancer (HRPC). Spectrum's partner, 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. A Phase 1 study evaluating satraplatin in combination with TAXOTERE(R) (docetaxel) in patients with advanced solid tumors is also underway. Additional studies evaluating satraplatin in combination with other therapies in various cancers are planned. Further information on satraplatin can be found in the Anticancer Programs section of the Company's Web site at www.gpc-biotech.com.
Source: Spectrum Pharmaceuticals, Inc.