XBiotech, a developer of next-generation True Human therapeutic antibodies, has expanded its XCITE cancer study into Europe. XCITE is an FDA Fast-Tracked, pivotal phase III study of its cancer drug Xilonix for treatment of metastatic colorectal cancer. Screening now has begun at the Marii Sklodowskiej-Curie Oncology Center in Warsaw, Poland, marking the first patient recruitment site outside the U.S. and the commencement in earnest of the global phase of the FDA study.
Xilonix Colorectal cancer Immunotherapy Treatment Evaluation (XCITE) is designed to assess improvement in overall survival of patients in response to monotherapy with XBiotech’s True Human monoclonal antibody. The double-blinded, placebo-controlled study currently has about 98 sites in the U.S. and with the launch in Poland, will bring online more than 80 sites across Eastern and Western Europe. The XCITE trial will continue to expand to include nearly 200 clinical sites across 20 countries worldwide including Australia, Canada and South America. XBiotech expects to complete enrollment of this study by the end of 2016.
Total enrollment in the XCITE study will consist of 600 patients. The primary objective of the trial is to assess the ability of Xilonix to improve overall survival in patients with metastatic colorectal cancer who have failed standard therapies. The study also will assess progression free survival, tumor response, change in muscle mass and improvements in quality-of-life. Earlier observations of Xilonix therapy in advanced cancer patients revealed physical recovery that strongly correlated with significant improvements in survival. Based on these results, XBiotech received Fast Track designation from the FDA in October 2012 to develop Xilonix as a treatment in the setting of metastatic colorectal cancer.