AUSTIN, Texas, Jan. 17, 2017 (GLOBE NEWSWIRE) — XBiotech Inc. (NASDAQ:XBIT) today announced the publication of results from its pivotal phase 3 trial of the Company’s lead monoclonal antibody therapy. The results were published in The Lancet Oncology in an article titled, “MABp1 as a Novel Antibody Treatment for Advanced Colorectal Cancer: A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study.” The article is now available online.
“The findings indicate what we believe to be the first evidence that antibodies produced as a result of a natural human immune response can play a role in regulating disease progression in cancer,” said Prof. Tamas Hickish, lead author and Chair of the European Phase 3 Study. He stated, “The antibody was evaluated on the basis of how it improves health status as it antagonizes the disease.” And further, “Its risk benefit profile represents a new standard of care.”
Jolanta Gore-Booth, CEO of Europacolon, Europe’s leading colorectal cancer patient organization, said, “As a natural human antibody, we are delighted that patients who are already compromised from previous treatments are not subjected to the further effects of toxic drugs. A treatment for advanced cancer that helps improve patient health, or should we say wellbeing, has been long awaited!”
About Colorectal Cancer
Colorectal cancer is the second leading cause of malignancy in the industrialized world1. Because the incidence of colorectal cancer increases with economic development and aging, incidence is rising worldwide2. In Europe, approximately 470,000 patients will be diagnosed with colorectal cancer this year, and half will progress and ultimately succumb to the disease3. Disease progression is associated with significant morbidity, functional impairment and failure of multiple therapies, often with substantial toxicities. People with advanced disease are thus symptomatic and often unable to tolerate further treatment-related side effects, leaving an urgent need for more effective, less toxic therapies for these patients.
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
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.
About The Lancet Oncology
The Lancet Oncology is considered the leading publication worldwide for clinical oncology research4. The Lancet Oncology is ranked among the top three of the world’s leading oncology Journals and is in the top 0.5% of all scientific journals, of any discipline.
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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.
1 Lozano R, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380: 2095e128.
2 United European Gastroenterology (UEG). https://www.ueg.eu/press/releases/ueg-press-release/article/europe-is-falling-behind-america-in-the-fight-against-colorectal-cancer-due-to-low-screening-uptake/. Accessed April, 2016.
3 EuropaColon. http://www.europacolon.com/crcstatistics.php?Action=Crcstatistics. Accessed April, 2016.
4 2013 Journal Citation Reports®, Thomson Reuters 2014.
CONTACT: Contact Ashley Otero aotero@xbiotech.com 512-386-2930
