Patient enrollment begins for GPC Biotech's phase 2 study of satraplatin with Taxol to treat lung cancer

By E. Janene Geiss

Philadelphia, Dec. 9 - GPC Biotech AG announced Friday that a phase 2 study evaluating its lead drug candidate, satraplatin, in combination with Taxol (paclitaxel) as a first-line therapy in patients with unresectable advanced non-small cell lung cancer began patient enrollment.

Satraplatin is in a phase 3 registrational trial as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer. The company also is opening new clinical studies to explore the potential of satraplatin in a number of additional tumor types, according to a company news release.

The phase 2 study in advanced non-small cell lung cancer is an open-label study being led by investigators at the Sarah Cannon Research Institute in Nashville, Tenn. The study also will be open for accrual in their affiliated network of oncologists, Tennessee Oncology, officials said.

The primary objective of this study is to determine the objective response rate of satraplatin in combination with Taxol in these patients. The study also will examine time-to-progression and overall survival. The study is expected to enroll up to 40 patients, officials said.

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, officials said.

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, officials said.

"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, the research institute's medical director, in the release.

Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc.

GPC Biotech is a Munich, Germany, biopharmaceutical company discovering and developing new anticancer drugs.

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