Spectrum begins phase 2 trial of satraplatin plus Taxol for lung cancer

By Angela McDaniels

Seattle, Dec. 9 - Spectrum Pharmaceuticals Inc. said it has begun a phase 2 study evaluating satraplatin, the company's lead drug candidate, in combination with Taxol (paclitaxel) as a first-line therapy in patients with inoperable, advanced non-small cell lung cancer.

The primary objective of the open-label study is to determine the objective response rate of satraplatin in combination with Taxol. Researchers will also evaluate time to progression and overall survival, the company said.

The study is being led by investigators at the Sarah Cannon Research Institute in Nashville, Tenn., and is expected to enroll up to 40 patients.

"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," said F. Anthony Greco, medical director of the institute, in a company news release.

"We are pleased to see the progress made by our [licensing] partner, GPC Biotech, in moving the satraplatin development program forward," said Rajesh C. Shrotriya, chairman, chief executive officer and president of Spectrum, in the release.

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Unlike 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.

Satraplatin is also in a phase 3 registrational trial as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer. Clinical studies to explore the potential of satraplatin in a number of additional tumor types are also being planned, the company said.

Lung cancer is the leading cause of cancer death in the United States, the company said, with an estimated 163,000 deaths expected from the disease in 2005. Non-small cell lung cancer accounts for roughly 80% percent of all lung cancer cases.

Spectrum is a pharmaceutical company based in Irvine, Calif., that acquires, develops and commercializes prescription drug products for the treatment of cancer and other unmet medical needs.

GPC Biotech AG is a biopharmaceutical company based in Martinsried/Munich, Germany, that develops new anti-cancer drugs.

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