Novartis/GPC's SPARC trial continues after interim meeting

Swiss drug major Novartis, German drugmaker GPC Biotech AG and the USA's Pharmion Corp say that the independent Data Monitoring Board for their satraplatin Phase III registrational trial, SPARC (Satraplatin and Prednisone Against Refractory Cancer), in second-line chemotherapy for hormone-refractory prostate cancer has recommended the trial continue as planned after its latest interim analysis of overall survival data.

The DMB did not raise any safety concerns or recommend changes to the protocol. The SPARC trial, therefore, continues to completion and GPC Biotech and Pharmion remain blinded to the study data. The companies expect the full progression-free survival data to be available in the fall and, if the findings are positive, they anticipate completing the New Drug Application filing by the end of year, with a Marketing Authorization Application to the European regulatory authorities in the first quarter of 2007.