XBiotech Provides Update on Xilonix™ Phase III Programs in US and EU
AUSTIN, Texas, 2016-07-23 00:45 CEST (GLOBE NEWSWIRE) --
XBiotech Inc. (NASDAQ:XBIT), developer of next-generation True Human™ antibody therapies, said today that the Independent Data Monitoring Committee (DMC) for the XCITE Phase III clinical study of Xilonix™ 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™ 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.
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com.
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 SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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.
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