IRVINE, Calif., Dec. 9 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced the opening of accrual of a Phase 2 study evaluating the Company’s lead drug candidate, satraplatin, in combination with Taxol(R) (paclitaxel) as a first-line therapy in patients with unresectable advanced non-small cell lung cancer (NSCLC). Satraplatin is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer. New clinical studies to explore the potential of satraplatin in a number of additional tumor types are also being planned.
The Phase 2 study in advanced NSCLC is an open label study being led by investigators at the Sarah Cannon Research Institute (SCRI) in Nashville, Tennessee. The study will also be open for accrual in their affiliated network of oncologists, Tennessee Oncology. The primary objective of this study is to determine the objective response rate of satraplatin in combination with Taxol in this patient population. The study will also evaluate time to progression and overall survival. The study is expected to enroll up to 40 patients.
“I look forward to further exploring the potential of satraplatin with Taxol in the advanced lung cancer setting, as this new study builds on the Phase 1 study my team did with this combination,” said F. Anthony Greco, M.D., Medical Director, SCRI. “Platinum-based therapies are widely used to treat patients with advanced non-small cell lung cancer. Satraplatin, as an oral platinum-based compound that is well tolerated could, if effective, be an important new option for treating patients with this disease.”
“We are pleased to see the progress made by our partner, GPC Biotech, in moving the satraplatin development program forward,” stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum. “The initiation of additional, exploratory studies using satraplatin in combination therapies, as well as for additional indications, is another step towards realizing the potential this drug might have on the treatment of cancer. The benefits of having a highly-regarded research institution such as The Sarah Cannon Research Institute and Dr. Greco, a distinguished medical oncologist, involved with this process, will be an important factor in ensuring the potential market acceptance and success of this important drug.”
Lung cancer is the leading cause of cancer death in the U.S., with an estimated 163,000 deaths expected from the disease in 2005. Over 170,000 new cases are expected to be diagnosed in 2005. The five-year survival rate for lung cancer in the U.S. is only 15 percent. Recent statistics for Europe estimated over 375,000 cases annually of lung cancer and over 345,000 deaths from the disease. NSCLC accounts for approximately 80 percent of all lung cancer cases.
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. Worldwide sales of these drugs exceeded $2.2 billion in 2004. 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. The Phase 3 registrational trial -- the SPARC trial -- as a second-line chemotherapy treatment for hormone-refractory prostate cancer (HRPC) has just reached its target enrollment. The FDA has also granted fast track designation to satraplatin for this indication.
Phase 2 trials have been completed in HRPC, ovarian cancer and small-cell lung cancer. Promising early clinical results have also been shown when satraplatin is combined with radiation therapy, and a Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. Several others studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned. Further information on satraplatin can be found at the Company’s website at www.spectrumpharm.com or in the Anticancer Programs section of GPC Biotech’s website at www.gpc-biotech.com.
TAXOL(R) (paclitaxel) is a registered trademark of Bristol-Myers Squibb Company.
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 www.spectrumpharm.com.
Forward-looking statements
This press release contains 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 initiation of new clinical studies to explore the potential of satraplatin in a number of additional tumor types as well as in combination therapies, enrolling up to 40 patients in the Phase 2 study, the potential of satraplatin with Taxol in the advanced lung cancer setting, that satraplatin could be an important new option for treating patients with non-small cell lung cancer, taking steps towards realizing the potential this drug might have on the treatment of cancer, ensuring the potential market acceptance and success of satraplatin, the advantages of an oral platinum drug, including ease of administration and patient convenience, in a variety of applications, 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.
Spectrum Pharmaceuticals, Inc.
CONTACT: Laurie Little, Sr. Director, Investor Relations of SpectrumPharmaceuticals, Inc., +1-949-743-9216
