- 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).
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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Contacts: XBiotech Ashley Otero email@example.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