IRVINE, Calif., May 16 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that its partner, GPC Biotech AG, has initiated a Phase 1 study evaluating the Company’s lead drug candidate, satraplatin, in combination with Xeloda* (capecitabine) in patients with advanced solid tumors. Xeloda* is an oral form of 5-FU, a marketed chemotherapy treatment that is used to treat various cancers, including metastatic breast and colorectal cancers. Under Spectrum’s agreement with GPC Biotech AG for satraplatin, GPC is responsible for fully funding development expenses, including this clinical trial, and will pay Spectrum royalties based on sales of this compound.
The Phase 1 open label study is being conducted at Northwestern University Medical Center in Chicago under the direction of William Gradishar, M.D., Professor of Medicine, Director, Breast Medical Oncology, a distinguished medical oncologist whose research has been instrumental in developing novel anticancer therapies. The primary objective of this study is to determine the maximum tolerated dose for satraplatin in combination with Xeloda* in patients with advanced solid tumors. The trial is expected to enroll up to 24 patients.
Dr. Gradishar commented: “Combinations of intravenous 5-FU and certain marketed platinum compounds have shown activity in a number of cancers. I am excited about the potential that the combination of satraplatin and Xeloda* may hold. This oral-oral regimen, if effective, may offer doctors an important new, well tolerated and convenient treatment option for patients with a variety of cancers.”
“This is the first study evaluating satraplatin in a fully oral combination,” said Dr. Rajesh C. Shrotriya, Chairman, Chief Executive Officer and President of Spectrum. “Multiple clinical trials are already underway for other satraplatin combinations in a number of cancer types. What is exciting about this trial is that it’s an all-oral regimen, which may enable patients to take their treatments at home, rather than at the hospital.”
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 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.
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 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, the study’s ability to determine the maximum tolerated dose for satraplatin in combination with Xeloda* in patients with advanced solid tumors, that the trial will enroll up to 24 patients, the potential of the combination of satraplatin and Xeloda*, including, if effective, that it may offer doctors an important new, well tolerated and convenient treatment option for patients with a variety of cancers, the possibility of enabling patients to take their treatments at home instead of being treated at the hospital, 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.
*Xeloda (capecitabine) is a registered trademark of Hoffmann-LaRoche AG. Contacts: Rajesh C. Shrotriya, M.D. Jeanie D. Herbert Chairman, CEO and President Investor Relations (949) 743-9295 (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/
