IRVINE, Calif., April 3 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced the presentation of new pre-clinical data on its lead drug candidate satraplatin at the 97th Annual Meeting of the American Association for Cancer Research (AACR) in Washington, DC.
"The data presented at AACR are supportive of the clinical work which is underway to explore the potential of satraplatin in a variety of combination therapies and cancer settings," said Dr. Rajesh C. Shrotriya, Chairman, Chief Executive Officer and President of Spectrum. "Two Phase 1 trials are currently ongoing evaluating satraplatin in combination with Taxotere in advanced solid tumors. A Phase 2 study evaluating satraplatin in metastatic breast cancer is also underway, and further studies to explore satraplatin in this treatment setting in combination with other therapies, such as Herceptin(R), are being planned."
A poster entitled, "Synergistic antitumor activity of the combination of satraplatin and docetaxel in H460 human non-small cell lung carcinoma xenografted in nude mice," (Abstract #563) showed results from in vivo studies evaluating the efficacy of satraplatin and Taxotere(R) (docetaxel), both individually and in combination, using various dosing and treatment schedules. Within the range of doses and schedules tested, a combination of the two compounds administered sequentially results in therapeutically synergistic effects - i.e., superior to the best result that could be obtained with either agent administered individually - with no apparent increase in toxicity compared to either single agent in this tumor model. Results evaluating satraplatin and Taxol(R) (paclitaxel) in this non-small cell lung cancer model were presented in late 2005. The pre-clinical results presented at AACR build on previous data evaluating satraplatin in combination with Taxotere(R) in cells and may be useful in developing appropriate dosing schedules for clinical testing of a combination therapy of satraplatin and Taxotere(R).
A poster entitled, "Synergistic in vitro anticancer activity of JM118, a metabolite of satraplatin, in combination with Herceptin(R)," (Abstract #1350) evaluated satraplatin's active metabolite, JM118, in combination with Herceptin(R) (trastuzumab) against SKBR-3 breast cancer cells, which are known to be sensitive to Herceptin(R). The data showed that, within the range of doses and schedules tested, both concurrent and sequential exposure of the cells to these two compounds resulted in strong synergistic cytotoxic activity. Currently there is underway a Phase 2 trial evaluating satraplatin in patients with metastatic breast cancer. This study is being conducted to gain more insight into the activity of satraplatin in this important cancer area. The data presented support further exploration of the combination of satraplatin and Herceptin(R) in breast cancer patients.
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. 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. Spectrum believes that satraplatin is also the only platinum compound that has demonstrated activity in a randomized trial in hormone-refractory prostate cancer (HRPC).
Patient enrollment in a Phase 3 registrational trial, the SPARC trial, which is assessing the safety and efficacy of satraplatin in combination with prednisone as a second-line chemotherapy in patients with HRPC, has been completed. In December 2005, GPC Biotech, the Company's co-development partner, initiated the rolling submission of a New Drug Application with the U.S. Food and Drug Administration (FDA).
Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in HRPC, ovarian cancer and small cell lung cancer. Other trials evaluated the effects of adding satraplatin to radiation therapy, a clinical application in which satraplatin's oral bioavailability could be particularly advantageous. A Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. Several other Phase 1 and 2 studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned. Spectrum licensed worldwide rights to satraplatin to GPC Biotech in 2002 and retained co-promotion rights in the USA under certain conditions. 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.
Additional information on satraplatin can be found on Spectrum's website at http://www.spectrumpharm.com and in the Anticancer Programs section of GPC Biotech's website at http://www.gpc-biotech.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 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, the potential of satraplatin in a variety of combination therapies and cancer settings, the advantages of an oral platinum drug, including ease of administration and patient convenience, in a variety of applications, that satraplatin is the only platinum compound that has demonstrated activity in a randomized trial in hormone-refractory prostate cancer, the effects of adding satraplatin to radiation therapy, a clinical application in which satraplatin's oral bioavailability could be particularly advantageous, that several other Phase 1 and 2 studies evaluating satraplatin in combination with other therapies and in various cancers will be initiated, that Spectrum will obtain co-promotion rights in the USA 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 will 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. 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 Spectrum Pharmaceuticals, Inc. (949) 743-9295 Jeanie D. Herbert Investor Relations Spectrum Pharmaceuticals, Inc. (949) 743-9216
Spectrum Pharmaceuticals, Inc.CONTACT: Rajesh C. Shrotriya, M.D., Chairman, CEO and President, SpectrumPharmaceuticals, Inc., +1-949-743-9295, Jeanie D. Herbert, InvestorRelations, Spectrum Pharmaceuticals, Inc., +1-949-743-9216
Web site: http://www.spectrumpharm.com//
