XBiotech has conducted a number of Phase I/II clinical trials for its lead product candidate MABp1. To date, multiple clinical trials testing MABp1 (Xilonix™) monotherapy have been conducted, including the treatment of late stage cancer, diabetes, vascular disease, acne, psoriasis, and pyoderma gangrenosum. Results from these studies have formed the basis for FDA Fast Track designations for the treatment of colorectal cancer, as well as for patients undergoing treatment for vascular disease. A Phase III pivotal study was launched in 2013 for the use of Xilonix™ in improving survival in metastatic colorectal cancer patients. XBiotech has also worked with the European Medicines Agency (EMA) to establish a regulatory path in Europe and launched a Phase III registration study there in March 2014, evaluating Xilonix™ in symptomatic colorectal cancer patients refractory to standard therapy.
*The MABp1 anti-IL-1α therapeutic antibody has been assigned different names depending on the clinical indication, such as MABp1, Xilonix™, CA-18C3, CV-18C3, RA-18C3, T2-18C3, etc. Each of these, however, contain the same True Human™ antibody MABp1.