Satraplatin improves PFS in HRPC patients

German drugmaker GPC Biotech AG and USA-based Pharmion Corp say that final data from the Phase III SPARC trial show highly statisically-significant improvement in progression-free survival in hormone-refractory prostate cancer (HRPC) patients.

According to the findings, presented at the American Society for Clinical Oncology's Prostate Cancer Symposium, in Orlando Florida, satraplatin significantly reduces the risk of disease progression in HRPC patients using the protocol-specified log-rank test. The hazard ratio of 0.6 (95% CI: 0.5-0.7, p<0.00001), which was first reported in September 2006, adjusted for nine pre-specified prognostic factors. Using a more conservative analysis, which adjusted only for the three pre-specified stratification factors, the hazard ratio is 0.67 (95% CI: 0.57-0.77, p=0.0000003). These hazard ratio numbers correspond to a reduction in relative risk of disease progression of 40% and 33%, respectively.

GPC, which licensed the agent from the USA's Spectrum Pharmaceuticals in 2002, recently completed the New Drug Application submission for satraplatin to the US Food and Drug Administration, while Pharmion expects to complete a Marketing Authorization Application for Europe in the second quarter of the year.