XBiotech Phase 3 Data for Colorectal Cancer Therapy is Published in The Lancet Oncology
January 17 2017 - 8:00AM
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
AntibodiesUnlike 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 OncologyThe
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.
Cautionary Note on Forward-Looking
StatementsThis 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
Ashley Otero
aotero@xbiotech.com
512-386-2930
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