XBiotech Provides Update on Xilonix™ Phase III Programs in US and EU
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
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
About Xilonix™ and Interleukin-1 alpha (IL-1α)
Xilonix™ is the first monoclonal antibody to specifically target and neutralize interleukin-1 alpha (IL-1α), one of the most potent inflammatory signaling molecules. The IL-1 pathway in general, and IL-1α 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-1α 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.
About True Human™ Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
About XBiotech
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our
i Apte RN, Voronov E. Interleukin-1 a major pleiotropic cyto-kine in tumor-host interactions. Can Biol. 2002;12:277–290.
ii Dinarello CA. Interleukin-1α neutralisation in patients with cancer. Lancet Oncol. 2014;15(6):552-553.
Investor RelationsScott Whitehurst Phone: 512.386.2993 Email: swhitehurst@xbiotech.com Media Ex-U.S. Jonathan Kearney +44 20 8618 2755 Media U.S. Ashley Cadle 310.463.0143