Munich, Germany, 24 January, 2011. WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) today announced the achievement of a major clinical milestone. Over 340 recurrences have now been reported to WILEX by the local sites. Therefore the process for the interim analysis of efficacy in the Phase III registration trial with the drug candidate RENCAREX® in the indication renal cancer has now been started. The process involves the central analysis of the data from all 864 patients by independent radiologists. The interim analysis will be carried out by an Independent Data Monitoring Committee (IDMC) and should provide definitive information regarding the endpoint of the trial relevant for approval, namely “disease-free survival”. The results of the interim analysis of efficacy are expected to be available in about six months.
The drug candidate RENCAREX® is based on the antibody Girentuximab, which binds to the tumour-specific antigen CA IX – an antigen that is overexpressed in clear cell renal cell carcinomas. The therapeutic antibody makes the tumour visible to the endogenous immune system, recruiting natural killer cells which can destroy any existing cancer cells. RENCAREX® should inhibit the further growth and recurrence of clear cell renal cell carcinomas a particularly aggressive type of cancer and kill cancer cells, thereby prolonging the disease-free survival of patients.