- First Time Pivotal Phase 3 Xilonix™ Data To Be Unveiled at Major Scientific Congress
- Developed Specifically to Treat Advanced Cancer, Xilonix™ is First Antibody Therapy to Neutralize Biological Activity of Interleukin-1α (IL-1a)
- Xilonix™ Recently Granted Accelerated Review for Marketing Authorization by the European Medicines Agency (EMA); a decision on Xilonix™ approval could come as early as fourth quarter 2016
AUSTIN, Texas, April 19, 2016 (GLOBE NEWSWIRE) — XBiotech Inc. (NASDAQ:XBIT), developer of next generation True Human™ antibody therapies, today announced it will present pivotal Phase 3 data for Xilonix™, the Company’s lead therapy developed for the treatment of advanced colorectal cancer, at the 18th ESMO World Congress on Gastrointestinal Cancer. This will be the first presentation of the Phase 3 data at a major scientific congress. The 18th ESMO World Congress on Gastrointestinal Cancer, considered the premier scientific event for gastrointestinal cancer, will be held June 29 to July 2 in Barcelona, Spain.
A potential breakthrough for patients with advanced colorectal cancer, Xilonix™ is specifically designed to target and neutralize interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis (the growth and spread of tumors), as well as mediate symptoms such as metabolic dysregulation (e.g., a cause of muscle loss and weight loss), fatigue and anxiety associated with advanced cancer.
The abstract, entitled “A Pivotal Phase 3 Trial of Xilonix™ in Advanced Colorectal Cancer,” will be presented by Dr. Tamas Hickish, Chair of the Xilonix™ European Phase 3 Study, and Consultant Medical Oncologist, Royal Bournemouth Hospital NHS Foundation Trust, UK. Colorectal cancer is the leading cause of malignancy in the industrialized world.
About True Human™ Therapeutic Antibodies
XBiotech is pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are 100 percent human, derived 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.
The first of these therapies, Xilonix™, for advanced colorectal cancer is in Phase 3 clinical trials in the United States with a Fast Track designation by the U.S. Food and Drug Administration (FDA). In Europe, Xilonix™ Phase 3 clinical trials have been completed, and the therapy is under accelerated review following the validation of its Market Authorization Application by the European Medicines Agency (EMA).
About XBiotech
XBiotech is a fully integrated global 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 improve the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech is expanding its state-of-the-art manufacturing with launch of a new commercial-scale facility in 2016. The manufacturing process has been designed to dramatically reduce time and cost while increasing flexibility, representing a new approach to biotech manufacturing. For more information, visit www.xbiotech.com.
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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.
CONTACT: Contacts: XBiotech Ashley Otero aotero@xbiotech.com 512.386.2930 Media liaison U.S. Mariann Caprino 917.242.1087 Media liaison ex-U.S. Jonathan Kearney +44 20 8618 2755; Mobile: +44 7725 925 841
