GPC Biotech, Pharmion recommended for analysis of satraplatin phase 3 trial

By Elaine Rigoli

Tampa, Fla., May 17 - GPC Biotech AG and Pharmion Corp. announced that the independent Data Monitoring Board for the satraplatin phase 3 registrational trial, Sparc (satraplatin and prednisone against refractory cancer), has notified the companies that it wants to conduct an expedited interim analysis of overall survival data from the Sparc trial.

The companies have agreed to this request, and the Data Monitoring Board is expected to meet to discuss the data prior to the end of the second quarter of 2006.

The Data Monitoring Board consists of independent oncology and statistical experts whose primary responsibility is to monitor, on a periodic basis, the data from the Sparc trial and to provide recommendations to GPC Biotech and Pharmion on whether the study should proceed as originally planned, be modified or be discontinued for efficacy or safety reasons.

Members of the Data Monitoring Board are independent from GPC Biotech and Pharmion and also do not participate as clinical investigators in the Sparc trial.

GPC Biotech and Pharmion said they have not had access to the data that caused the Data Monitoring Board to request this expedited review of overall survival; however, in its April 25 meeting, the board had access to preliminary overall survival data. The companies are now and will continue to remain blinded to the data during this review process.

GPC Biotech is a biopharmaceutical company developing anticancer drugs and has headquarters in Munich, Germany.

Pharmion is a biotech company with corporate headquarters in Boulder, Colo.

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