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Phase 2 Trial Initiated of Satraplatin in Combination With Erlotinib in Inoperable, Advanced Non-small Cell Lung Cancer
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.
Source: Spectrum Pharmaceuticals