GPC Biotech's SPARC study gets DMB OK
Germany's GPC Biotech says that the independent data monitoring board for the Phase III Satraplatin and Prednisone Against Refractory Cancer study (SPARC), has reviewed the interim safety and efficacy data and recommended that the program continue to completion. The trial is designed to assess the drug's use as a second-line treatment for hormone-refractory prostate cancer.
The DBM reviewed data from 354 progression-free survival events in addition to reviewing safety data from the first 593 enrolled subjects.
GPC's chief executive officer, Bernd Seizinger, said that, based on the DBM's conclusion, the firm's board had voted that the trial should continue. Dr Seizinger added that the company intended to submit a New Drug Application for regulatory consideration before the end of the year. Drug analysts at Lehman Brothers reiterated their 1-overweight rating on the firm.
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