Spectrum Pharmaceuticals, Inc. Release: Independent Data Monitoring Board Recommends That Satraplatin Phase 3 Trial Continue As Planned
No safety concerns were raised by the DMB, and it recommended that the trial continue as planned, without changes. The trial, therefore, continues to completion. Spectrum, GPC Biotech and Pharmion remain blinded to the study data. As previously communicated, the full progression free survival data should be available in the fall of 2006. Progression free survival remains the endpoint of the SPARC trial for accelerated approval in the U.S. and is also the basis, along with supporting overall survival data, for approval in Europe.
"We look forward to reporting the final progression free survival results from the trial this fall. If the data are positive, we anticipate the NDA filing will be completed by the end of 2006," said Dr. Luigi Lenaz, Chief Scientific Officer of Spectrum. "In the meantime, additional clinical trials with satraplatin will be initiated in other cancer indications and in combination with other anti-cancer treatments."
About the Data Monitoring Board
The Data Monitoring Board consists of independent oncology and statistical experts whose primary responsibility is to monitor, on a periodic basis, the data from the SPARC trial and to provide recommendations to Spectrum, GPC Biotech and Pharmion on whether the study should proceed as originally planned, be modified or be discontinued. Members of the Data Monitoring Board are independent from Spectrum, GPC Biotech and Pharmion and also do not participate as clinical investigators in the SPARC trial.
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. 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.
Spectrum out-licensed satraplatin to GPC Biotech AG in 2002, and GPC Biotech fully funds all development expenses. In December 2005, the accrual to the SPARC trial was completed and the rolling submission of a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (FDA) was initiated. Also in December 2005, GPC Biotech signed a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion was granted exclusive commercialization rights to satraplatin for Europe and certain other territories outside the U.S.
Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in hormone-refractory prostate cancer, ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals, Inc. is a specialty pharmaceutical company based in Irvine, California, 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 www.spectrumpharm.com.
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, satraplatin's ability to treat hormone- refractory prostate cancer, the potential of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers, the initiation of additional clinical trials for satraplatin, that the final progression free survival results from the trial are expected this fall, that if the data are positive, we anticipate the NDA filing will be completed by the end of 2006 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 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. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
Contacts: Rajesh C. Shrotriya, M.D. Chairman, CEO and President (949) 743-9295
Jeanie D. Herbert Investor Relations (949) 743-9216
Source: Spectrum Pharmaceuticals, Inc.