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Spectrum: Spectrum Pharmaceuticals
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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.
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IRVINE, Calif., Nov. 13 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that it will receive a $5 million milestone payment under its agreement with Par Pharmaceutical Companies, Inc. for sumatriptan injection. Sumatriptan injection is a prescription medicine for the acute treatment of migraine attacks. The branded product, Imitrex(R), is marketed by GlaxoSmithKline.
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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, […]
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IRVINE, Calif., July 30, 2007 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc., today announced that GPC Biotech has withdrawn the satraplatin New Drug Application (NDA) filed for accelerated approval for the treatment of hormone-refractory prostate cancer. The decision was based on the vote by the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) on July 24, 2007 that the FDA should wait for the survival analysis of the SPARC trial before deciding whether satraplatin is approvable.
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Spectrum Pharmaceuticals completed a multi-center, Phase 2 clinical trial in Europe. The results of the trial showed that EOquin was well-tolerated and produced a 67% CR (complete response) in patients, many of whom had been treated multiple times. The data from this study were presented to the FDA in early 2006.
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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.
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