IRVINE, Calif., June 6 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced the presentation of new clinical data on its lead drug candidate satraplatin, currently in a fully enrolled Phase 3 trial, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia.
A poster entitled, "Phase 1 Study of the Effects of Hepatic Impairment on the Pharmacokinetics (PK) and Safety of Satraplatin in Patients with Refractory Non-Hematologic Cancer," presented study data on 19 patients with advanced solid tumors and with varying degrees of hepatic impairment (reduced liver function). The study was designed to show the effect of hepatic impairment on the pharmacokinetics of satraplatin in patients with advanced forms of cancer. Most patients in the study were heavily pre-treated. As this study is still ongoing, the data reported are considered preliminary. Satraplatin appears to be well tolerated in patients with mild to moderate liver impairment. As expected, the main toxicities observed thus far have been hematologic -- anemia, thrombocytopenia (decrease in platelets in the blood) and neutropenia (decrease in white blood cells). Non-hematologic toxicities like diarrhea, anorexia, and fatigue have been mild. No significant cardio-, liver or neurological toxicities have yet been observed.
A second poster entitled, "Phase 1 Study of the Effects of Renal Impairment on the Pharmacokinetics and Safety of Satraplatin in Patients with Refractory Non-Hematologic Cancer," presented study data on 24 patients with advanced solid tumors and with varying degrees of renal impairment (reduced kidney function). The study was designed to show the effect of renal impairment on the pharmacokinetics of satraplatin in patients with advanced forms of cancer. As this study is still ongoing, the data reported are considered preliminary. Satraplatin appears to be well tolerated in these patients. As expected, the main hematological toxicities observed to date have been anemia and thrombocytopenia. Common toxicities like nausea, vomiting, diarrhea, fatigue and anorexia have to date been mild. No significant cardio-, renal, liver or neurological toxicities have yet been observed.
As patients with advanced cancer may often have limited function of the liver and/or kidneys, it is important to understand how these impairments affect how a drug is used by the body. The results of these two studies should help clinicians understand the tolerability and appropriate dosing of satraplatin in cancer patients whose liver or kidney function are compromised.
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.
Spectrum out-licensed satraplatin to GPC Biotech AG in 2002, and GPC Biotech fully funds all development expenses. In December 2005, GPC Biotech completed accrual to the SPARC trial that is evaluating satraplatin in combination with prednisone as second-line chemotherapy in patients with hormone refractory prostate cancer. Also in December 2005, GPC Biotech initiated the rolling submission of a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (FDA) and 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.
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.
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, 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 DMB will meet to discuss the data prior to the end of the second quarter 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
Spectrum Pharmaceuticals, Inc.CONTACT: Rajesh C. Shrotriya, M.D., Chairman, CEO and President,+1-949-743-9295, or Jeanie D. Herbert, Investor Relations, +1-949-743-9216,both of Spectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
