Healthcare Industry News: GPC Biotech
News Release - August 2, 2006
Spectrum Pharmaceuticals Announces Initiation of Phase 2 Trial Evaluating Satraplatin in Combination With Tarceva in Patients With Inoperable, Advanced Non-small Cell Lung CancerIRVINE, Calif., Aug. 2 (HSMN NewsFeed) -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI ) announced today that its partner, GPC Biotech, has initiated a Phase 2 randomized trial evaluating satraplatin in combination with TarcevaŽ (erlotinib) as a first-line therapy in patients with inoperable, advanced non-small cell lung cancer (NSCLC) who are 70 years of age and older. A Phase 3 registration trial exploring satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer has completed patient enrollment. Additional clinical studies are being explored to explore the potential of satraplatin as a single agent or in combination with different drugs and other treatment modalities in a variety of tumor types.
The Phase 2 study in advanced NSCLC is a randomized trial that is expected to involve more than 20 centers in the U.S. and Europe and enroll approximately 120 patients. The primary objective of this study is to evaluate progression-free survival. The study will also examine overall survival, response rates and safety. Patients in the Phase 2 trial will be randomized to receive satraplatin plus Tarceva or Tarceva alone. A sequential dosing regimen will be used in the satraplatin arm. The treatment cycle for both arms is 28 days. Patients will be stratified according to smoking history and gender.
"We are pleased that our partner is committed to rapidly advancing satraplatin through clinical development in multiple indications," stated Rajesh Shrotriya, M.D., president and chief executive officer of Spectrum. "Our partnership for the development of satraplatin is consistent with our risk-reduced drug development strategy, and it provides us with a potential source of non-dilutive funding with which we will advance our proprietary oncology pipeline. If successful, we expect to begin receiving milestone and royalty payments for satraplatin as early as next year, starting with the acceptance by the FDA of the NDA submission of the drug for hormone-refractory prostate cancer. The rolling NDA filing remains on track, and is expected to be completed by end of the year"
About Lung Cancer
Lung cancer is the leading cause of cancer death in the U.S., with an estimated 162,000 deaths expected from the disease in 2006. Over 170,000 new cases are expected to be diagnosed in 2006. 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 over 80% of all lung cancer cases, and over 50% of patients present with inoperable disease.
Standard first-line chemotherapy for patients with advanced NSCLC typically involves a combination regimen, frequently with a platinum-based therapy. For elderly patients or patients with a poor performance status, a single-agent chemotherapy may be recommended due to concerns about these patients' ability to tolerate a combination regimen. Thus, there is a need for well-tolerated, effective combination treatments.
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 Phase 3 registrational 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.
Spectrum Pharmaceuticals is opportunistically acquiring and advancing a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum's expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. 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, Spectrum's ability to identify, acquire and develop its portfolio of drug candidates, the Company's promising pipeline, that Spectrum will receive royalties from sales of satraplatin, the expected number of centers and patients involved in the Phase 2 study, that satraplatin provides us with a potential source of non-dilutive funding with which we will advance our proprietary oncology pipeline, that we will begin receiving milestone and royalty payments from GPC Biotech for satraplatin as early as next year, the acceptance by the FDA of the NDA submission of satraplatin for hormone-refractory prostate cancer, that the rolling NDA filing will be completed by end of the year, that other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers will be initiated 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.
Source: Spectrum Pharmaceuticals
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