XBiotech Provides Update on Xilonix(TM) Phase III Programs in US and EU

AUSTIN, Texas, July 22, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT), developer of next-generation True Human(TM) antibody therapies, said today that the Independent Data Monitoring Committee (DMC) for the XCITE Phase III clinical study of Xilonix(TM) for the treatment of colorectal cancer, recently recommended study continuation without any amendment to the study design. The DMC convened as scheduled, subsequent to the enrollment of 400 patients into the study.

The DMC mandate is to "monitor for early evidence of treatment harm and to routinely recommend to continue, suspend, or otherwise modify enrollment based on their findings." The DMC did not have any recommendations for the Company regarding any need for changes to the study operation. This is viewed as a positive assessment with respect to safety, as well as to key aspects of study execution. Another DMC meeting is scheduled to occur either after 600 patients have been enrolled, or potentially earlier if the study meets its first planned efficacy analysis milestone. Xilonix has been granted FDA fast-track review and the XCITE study is on schedule to reach its enrollment milestones in 2016.

The Company's marketing authorization application for Xilonix for the treatment of colorectal cancer remains on schedule to achieve a decision in 2016 by the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). The Company recently scheduled an in-person meeting with the CHMP. The Company believes the meeting will help advance the marketing authorization process and has agreed with the CHMP for the MAA to be reviewed under the standard assessment timetable, rather than the accelerated review timeline that was granted in April 2016. The Company says that the standard timetable will provide additional time to conduct the MAA process. The standard timetable is expected to add approximately 60-days to the review proceedings.

About Xilonix(TM) and Interleukin-1 alpha (IL-1alpha) 
Xilonix(TM) is the first monoclonal antibody to specifically target and neutralize interleukin-1 alpha (IL-1alpha), one of the most potent inflammatory signaling molecules. The IL-1 pathway in general, and IL-1alpha in particular, is a desirable target for anti-cancer therapy because of its potential role in both local and systemic effects of cancer.^i,ii IL-1alpha in the tumor microenvironment is known to promote angiogenesis (the growth and spread of tumors), as well as mediate symptoms such as metabolic dysregulation (e.g., loss of weight and muscle mass), fatigue and anxiety associated with advanced cancer.