Xilonix (monoclonal antibody) filed with EMA for colorectal cancer- XBiotech
XBiotech announced that the Company has now submitted its Marketing Authorization Application (MAA) for its candidate therapy Xilonix (monoclonal antibody) for advanced colorectal cancer to the European Medicines Agency (EMA).
The candidate therapy subject of the MAA was recently evaluated in a Phase III clinical study for the ability to control disease-related symptoms that inversely correlate with survival. In addition to positive results regarding the primary endpoint of the pivotal study, complete data analysis demonstrated that key secondary measures of antibody activity were also improved. Inhibition of IL-1 alpha on the surface of platelets may represent an important anti-tumor, disease-modifying activity, due to the mechanism of action of Xilonix.
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