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(TM) Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech's True
Human(TM) 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(TM) 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.
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.
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.