Green light for new platinum-based cancer treatment trials 2nd September 2003

GPC Biotech has today announced that it has received written confirmation from the FDA (US Food and Drug Administration) to begin a trial of a new platinum-based treatment for prostate cancer.

Using satraplatin plus prednisone in patients who have failed prior treatment with chemotherapy the company hopes to develop a new method for helping to combat the onset of prostate cancer.

The satraplatin Phase 3 clinical trial protocol has successfully completed the SPA process, with the trials now set to be developed further.

The satraplatin registrational Phase 3 study will assess the safety and efficacy of satraplatin in combination with prednisone as a second-line chemotherapy regimen in patients with hormone-refractory prostate cancer (HRPC).

The firm says its main objective is to evaluate pain control and survival, as well as an assessment of drug safety.

'We are pleased to have received clearance from the FDA to proceed with the Phase 3 study. Our discussions with the FDA have been very constructive in developing the trial design, and we will continue to work closely with the Agency throughout the trial process,' commented Marcel Rozencweig, senior vice president of drug development at GPC Biotech.

Satraplatin is a member of the platinum family of compounds, but unlike platinum compounds currently on the market, satraplatin is orally administered.


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