FDA advisory committee recommends that FDA wait for overall survival results from Satraplatin phase 3 trial

Jul 25 2007

GPC Biotech AG has announced that the Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug Administration (FDA) recommended (12-0) that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether the satraplatin application is approvable for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed.

The FDA is not bound by the recommendations of advisory committees but will consider their advice when reviewing an applicant's NDA.

The Company said that, due to a recent slowing in the reported rate of deaths in the SPARC trial, final overall survival results could take longer than the previously communicated timeframe of the fall of this year.

"While we are extremely disappointed that ODAC has recommended that the FDA wait for the results of the overall survival analysis, we will continue to work with the FDA as the agency continues its review of the satraplatin application," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC Biotech. "We continue to believe strongly in the potential for satraplatin to help hormone-refractory prostate cancer patients who today have very limited treatment options."

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. Satraplatin is not currently approved by the FDA in the United States, by the EMEA in the European Union or any other regulatory authority, and no conclusions can or should be drawn regarding its safety and efficacy.

A Phase 3 registrational trial, called SPARC, is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone- refractory prostate cancer whose prior chemotherapy has failed. Data from the trial on progression-free survival and on safety have been presented at recent medical conferences. Satraplatin is currently under review by the U.S. FDA for hormone-refractory prostate cancer patients whose prior chemotherapy has failed.

GPC Biotech has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories. GPC Biotech has also entered into an agreement with Yakult Honsha Co. Ltd. under which Yakult has been granted exclusive commercialization rights to satraplatin for Japan. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.

Satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned.