Rencarex (WILEX) programme in Renal Cell Carcinoma is cancelled
WILEX AG has agreed a package of restructuring measures with the company's Supervisory Board. The Executive Management Board is reacting to the results of the Phase III ARISER study with Rencarex which missed the primary endpoint. The measures are designed to tailor development activities to the remaining projects, reduce the risks inherent in the business model and lower operating costs substantially.
In recent weeks, the unblinded data from the ARISER study with Rencarex for adjuvant treatment of clear cell Renal Cell Carcinoma were analysed in depth. The results show that the patients were included in the trial in accordance with the study protocol. One important reason for the negative study result was that the patients in the placebo group showed a considerably longer disease free survival time than expected based on previously available scientific data. There were no indications of errors or discrepancies within the study. Subgroup and biomarker analyses are still being conducted but these will not change the published result of the study. WILEX will therefore not continue with this project.