Satraplatin for its Use in Second-Line Treatment for Hormone Refractory Prostate Cancer Continues in Phase 3
Apr 20, 2005, 09:30, Reviewed by: Dr.
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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.
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By Spectrum Pharmaceuticals, Inc.,
Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that its co-development partner for satraplatin, GPC Biotech AG (Nasdaq: GPCB) (Frankfurt Stock Exchange: GPC), disclosed that the independent Data Monitoring Board (DMB) for the satraplatin Phase 3 SPARC registrational trial in second-line hormone refractory prostate cancer held a meeting on April 18, 2005 to review safety data from the ongoing study. The DMB reviewed the safety data from the first 262 patients who were randomized in the trial and had completed at least one cycle of treatment. After reviewing the data, the DMB reported that the design and conduct of the trial remain sound and recommended that the trial continue as planned.
As previously reported, GPC Biotech remains on schedule to complete patient enrollment in the SPARC trial by the end of 2005 and to complete the NDA (New Drug Application) filing with the U.S. FDA in the second half of 2006.
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.
Additionally, satraplatin is the only platinum-based compound to have shown efficacy in a randomized clinical
trial in prostate cancer. Prostate cancer is the most common cancer among men in the U.S. and Europe. The number of patients with this disease is expected to increase with the aging population. As the disease advances, patients are
often treated with hormone therapy. Once patients fail hormone therapy, becoming hormone-refractory, follow-on treatment involves a limited number of options, including chemotherapy.
For patients who then fail first-line chemotherapy, there are currently no approved second-line chemotherapy regimens. Satraplatin is in a Phase 3 registrational trial -- the SPARC trial -- as a second-line chemotherapy treatment for HRPC.
GPC Biotech has successfully 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. 
- U.S. Food and Drug Administration (FDA)
www.spectrumpharm.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 contains 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, whether GPC Biotech will complete patient enrollment in the SPARC trial by the end of 2005 and complete the NDA filing with the U.S. FDA in the second half of 2006, the advantages of an oral platinum drug, the efficacy of satraplatin in prostate 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 past results will not be indicative of future results, 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 price and other competitive pressures may ake 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 Director,
(949) 743-9295
Laurie Little
Investor Relations
(949)743-7216
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