XBiotech Provides Update on Xilonix(TM) Phase III Programs in US and EU
(Thomson Reuters ONE) -
AUSTIN, Texas, July 22, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT),
developer of next-generation True Human(TM) antibody therapies, said today that
the Independent Data Monitoring Committee (DMC) for the XCITE Phase III clinical
study of Xilonix(TM) for the treatment of colorectal cancer, recently
recommended study continuation without any amendment to the study design. The
DMC convened as scheduled, subsequent to the enrollment of 400 patients into the
study.
The DMC mandate is to "monitor for early evidence of treatment harm and to
routinely recommend to continue, suspend, or otherwise modify enrollment based
on their findings." The DMC did not have any recommendations for the Company
regarding any need for changes to the study operation. This is viewed as a
positive assessment with respect to safety, as well as to key aspects of study
execution. Another DMC meeting is scheduled to occur either after 600 patients
have been enrolled, or potentially earlier if the study meets its first planned
efficacy analysis milestone. Xilonix has been granted FDA fast-track review and
the XCITE study is on schedule to reach its enrollment milestones in 2016.
The Company's marketing authorization application for Xilonix for the treatment
of colorectal cancer remains on schedule to achieve a decision in 2016 by the
European Medicines Agency Committee for Medicinal Products for Human Use (CHMP).
The Company recently scheduled an in-person meeting with the CHMP. The Company
believes the meeting will help advance the marketing authorization process and
has agreed with the CHMP for the MAA to be reviewed under the standard
assessment timetable, rather than the accelerated review timeline that was
granted in April 2016. The Company says that the standard timetable will provide
additional time to conduct the MAA process. The standard timetable is expected
to add approximately 60-days to the review proceedings.
About Xilonix(TM) and Interleukin-1 alpha (IL-1alpha)
Xilonix(TM) is the first monoclonal antibody to specifically target and
neutralize interleukin-1 alpha (IL-1alpha), one of the most potent inflammatory
signaling molecules. The IL-1 pathway in general, and IL-1alpha in particular,
is a desirable target for anti-cancer therapy because of its potential role in
both local and systemic effects of cancer.(i,ii) IL-1alpha in the tumor
microenvironment is known to promote angiogenesis (the growth and spread of
tumors), as well as mediate symptoms such as metabolic dysregulation (e.g., loss
of weight and muscle mass), fatigue and anxiety associated with advanced cancer.
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.
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.
(i )Apte RN, Voronov E. Interleukin-1 a major pleiotropic cyto-kine in tumor-
host interactions. Can Biol.2002;12:277-290.
(ii )Dinarello CA. Interleukin-1alpha neutralisation in patients with cancer.
Lancet Oncol. 2014;15(6):552-553.
Investor Relations
Scott Whitehurst
Phone: 512.386.2993
Email: swhitehurst(at)xbiotech.com
Media Ex-U.S.
Jonathan Kearney
+44 20 8618 2755
Media U.S.
Ashley Cadle
310.463.0143
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Source: XBiotech, Inc via GlobeNewswire
[HUG#2030296]
Datum: 23.07.2016 - 00:45 Uhr
Sprache: Deutsch
News-ID 484921
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