Independent board recommends GPC Biotech continue phase 3 trial of Satraplatin for prostate cancer

By Lisa Kerner

Erie, Pa., April 25 - The independent Data Monitoring Board for GPC Biotech AG's satraplatin phase 3 registrational trial in second-line chemotherapy for hormone-refractory prostate cancer recommended that the trial continue to completion.

The group of independent oncology and statistical experts reviewed efficacy data as assessed by the blinded independent progression review panel on the first 354 progression-free survival events. In addition, the board reviewed the safety data from the first 593 patients who had been randomized in the trial and had completed at least one cycle of treatment, prior to making its determination.

GPC plans to file a New Drug Application with the Food and Drug Administration by the end of the year, if the final study data is positive, according to a company news release.

The company said it will begin additional clinical trials with satraplatin in other cancer indications and in combination with other anticancer treatments.

Satraplatin, an investigational orally bioavailable compound drug, is a member of the platinum family of compounds.

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

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