XBiotech Completes Enrollment in Global Phase III Study using Xilonix Monotherapy to Treat Advanced Colorectal Cancer
(Thomson Reuters ONE) -
Enrollment Completed on Schedule in Global Phase III Study Under US FDA Fast
Track Program
AUSTIN, Texas, Dec. 07, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT),
developer of True Human(TM) therapeutic antibodies, today announced that
enrollment has been completed in its randomized, double-blind, placebo-
controlled Phase III study evaluating Xilonix as a treatment for advanced
colorectal cancer. The Phase III study is being conducted under Fast Track
designation from the FDA and involves over 600 advanced cancer patients from 18
countries world-wide. The Company reports that the first interim analysis
allowing an assessment by the Data Monitoring Committee (DMC) of both safety and
efficacy is expected as early as first quarter 2017.
"We have achieved another significant milestone in our oncology program," stated
John Simard, President & CEO of XBiotech. "Our team has remained on schedule
with this complex project and we now look forward to an interim analysis early
next year."
The double-blind, placebo-controlled Phase III study is randomized 2:1 with
patients receiving Xilonix or placebo plus best supportive care. Patients are
required to have metastatic colorectal cancer, and are required to have failed
regimens that include flouropyrimidines, oxaliplatin, irinotecan, and Cetuximab
or Panitumumab for patients with KRAS mutation. Patients continue on study until
there is evidence of radiographic progression. The primary endpoint of this
study is overall survival, with secondary endpoints including objective response
rate, progression free survival, change in lean body mass as measured by dual
energy X-ray absorptiometry (DEXA), and patient reported quality of life using
the validated EORTC QLQ C30 questionnaire. There are two scheduled interim
analyses and a final analysis. The study may be stopped for efficacy at either
interim analysis, which would potentially enable an early submission of a
request for marketing authorization. Patients are otherwise followed for up to
18 months in order to determine overall survival and the study is powered for
552 events at study conclusion.
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.
Contact
Ashley Otero
aotero(at)xbiotech.com
512.386.2930
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: XBiotech, Inc via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Bereitgestellt von Benutzer: hugin
" alt="Ucore/IBC Commission Engineering of Pre/Post MRT Production CircuitsDatum: 07.12.2016 - 14:00 Uhr
Sprache: Deutsch
News-ID 511481
Anzahl Zeichen: 5809
contact information:
Town:
Austin
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 173 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"XBiotech Completes Enrollment in Global Phase III Study using Xilonix Monotherapy to Treat Advanced Colorectal Cancer"
steht unter der journalistisch-redaktionellen Verantwortung von
XBiotech, Inc (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
