XBiotech Announces Discontinuation of Phase III Study for Colorectal Cancer Based on Second Interim Analysis
(Thomson Reuters ONE) -
AUSTIN, Texas, June 09, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT)
announced today that an Independent Data Monitoring Committee (IDMC) has
performed its second prospectively planned, unblinded analysis of the Phase 3
XCITE study for the Company's novel candidate antibody therapy for the treatment
of colorectal cancer. The IDMC had no safety concerns from the unblinded
analysis. However, the committee recommended the early termination of the study
since the findings were not sufficient to meet efficacy or the threshold for
continuation, which involved a prospectively defined acceptance boundary for the
interim analysis of less than or equal to p = 0.08.
John Simard, XBiotech President & CEO stated, "We are obviously disappointed
with these findings. In the coming weeks, the Company plans to analyze the data
extensively to further understand the primary and secondary endpoint data, as
well as to identify populations that may have benefited from the therapy. These
findings today will not affect our efforts to pursue approval of the therapy
based on the successful completion of the European study, which demonstrated
control of debilitating symptoms in colorectal cancer."
Patients enrolled in the XCITE study were randomized 2:1 to receive Xilonix or
placebo plus, in each case, best supportive care. Advanced colorectal cancer
patients were required to have previous failed regimens that included
flouropyrimidines, oxaliplatin, irinotecan, and Cetuximab (or Panitumumab for
patients with KRAS mutation). Patients were expected to continue in the study
until there was evidence of radiographic progression. The patients were to be
followed for up to 18 months in order to determine overall survival. The primary
endpoint of this study was overall survival, with secondary endpoints including
objective response rate, progression free survival, change in lean body mass and
patient reported quality of life measures.
About True Human(TM) Therapeutic Antibodies
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:
Datum: 09.06.2017 - 21:11 Uhr
Sprache: Deutsch
News-ID 547259
Anzahl Zeichen: 5723
contact information:
Town:
Austin
Kategorie:
Business News
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