IRVINE, Calif., Nov. 2 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that its co-development partner, GPC Biotech AG , has opened for accrual a Phase 2 study evaluating the Company's lead drug candidate, satraplatin, in patients with metastatic breast cancer who have received no more than one prior chemotherapy treatment regimen. The study is being managed by US Oncology. Satraplatin is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment for patients with hormone- refractory prostate cancer. Spectrum's partner, GPC Biotech, is also opening new clinical studies to explore the potential of satraplatin in a number of additional tumor types.
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%.
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 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 .
About US Oncology
US Oncology, headquartered in Houston, Texas, is one of the nation's largest healthcare services networks dedicated exclusively to cancer treatment and research. US Oncology network practices are provided with unparalleled opportunities to participate in the ongoing clinical research and development of the newest promising cancer therapies. The network is currently involved in approximately 77 research trials that are open for enrollment and has contributed to the development of 23 of 29 of the latest cancer-fighting drugs approved by the FDA for use. Since initiation of the network, more than 29,000 patients have participated in clinical trials that have been managed by the US Oncology Network. US Oncology is affiliated with 985 physicians operating in 494 locations, including 97 radiation oncology facilities in 33 states. For more information, visit or contact Kimberly Rutherford at (832) 601-6193 or Kimberly.Rutherford@usoncology.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 .
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, opening other new clinical studies to explore the potential of satraplatin in a number of additional tumor types, that satraplatin has demonstrated activity in a number of solid tumors, enrollment of 80 patients in the proposed trial, completion of enrollment in the phase III trial in hormone refractory prostate cancer by the end of the year, moving toward realizing the potential satraplatin might have on the treatment of cancer, that an oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications, the potential clinical results when satraplatin is combined with radiation therapy, the fact that satraplatin is relatively well tolerated and could provide an additional option for breast cancer patients, the compound's potential in treating the disease (breast 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 are not 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
Spectrum Pharmaceuticals, Inc.
CONTACT: Laurie Little, Sr. Director, Investor Relations, SpectrumPharmaceuticals, Inc., +1-949-743-9216
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