Positive interim data for Xilonix in Cachexia in CRC-XBiotech

XBiotech has announced interim results from its fast-tracked Phase III study being conducted in the US for its anti-cancer agent Xilonix (monoclonal antibody) in Colorectal Cancer patients patients with Cachexia. XBiotech conducted an interim analysis of the 40 patients that have entered the study to date. Over half of the patients have succumbed to disease, enabling a preliminary analysis of study endpoints. At the time of analysis, patients receiving Xilonix had a hazard ratio for risk of death of 0.33 compared with controls. The strong hazard ratio reveals a marked trend for improved survival in the Xilonix treated group compared to controls. The Company disclosed it has used the interim overall survival data in a model to predict the statistical significance of the survival benefit over the projected complete course of the study.

This model is said to indicate that, based on the current effect seen with Xilonix, a highly significant result would be obtained upon study completion, well beyond what is necessary for registration. Key pharmacodynamic measures were also reported to be consistent with the intended biological activity of the therapy; as well, secondary endpoints evaluating life quality were consistent with the observed survival benefit in Xilonix patients. Together, these data are considered to be strong supportive evidence of the drug's clinical activity.