XBiotech Presents Phase III Findings for its Antibody Therapy for Colorectal Cancer at the 2017 ASCO Meeting
(Thomson Reuters ONE) -
Data Show Reduced Disease Progression and Improved Survival for Patients
Achieving Primary Endpoint
AUSTIN, Texas, June 01, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT)
announced today that data from XBiotech's European Phase III Study of advanced
colorectal cancer patients treated with Hutruo (MABp1) will be presented at the
2017 American Society of Clinical Oncology (ASCO) meeting in Chicago, Illinois.
The abstract entitled, "MABp1 improves clinical outcomes of patients with
symptomatic refractory metastatic colorectal cancer patients: Per-Protocol
Population analysis of Phase III Study (PT026)" will be presented during the
Gastrointestinal Colorectal Cancer poster session on June 3, 2017 from
8am-11:30am. Dr. Lucjan Wyrwicz from the Maria Sklodowska-Curie Memorial Cancer
Centre, Institute of Oncology, Warsaw, will be leading the poster session.
The poster will provide analysis of how patients performed during and after
treatment with the prescribed 8 week treatment regimen. Patients that received
the full 8 weeks of treatment are considered to have completed the study "per
protocol" (i.e. did not leave the study early). Assessment of the treatment
outcome for the per protocol group is particularly important, since due to the
advanced stage of these patients, some are unable to complete the recommended
treatment regimen and are not able to have the full potential benefit from
therapy.
In the Phase III study, 82% of all patients that received at least one dose of
study drug did complete the 8 week treatment regimen. For these per protocol
patients, 40% of patients that received treatment with the antibody therapy
achieved the primary endpoint, nearly double compared to placebo (40% vs 23%,
relative risk 1.76, 95% CI 1.14 to 2.72, one-tailed p=0.003). Dr. Wyrwicz is
providing an analysis showing how patients in this population that achieved the
primary endpoint of the study had substantially improved survival outcomes, with
a median survival of 11.7 months versus 5.7 months for those that did not (HR
0.39; p<0.0001). Other key findings include RECIST assessment of tumor
progression, where radiographic evidence of stable disease was more than three-
fold better (42% vs 12%; p<0.001) in this population.
Dr. Wyrwicz commented, "This analysis confirms our previous report that
in an advanced cancer population, the combination of patient-reported symptoms
and radiography used as the primary endpoint is a powerful measure of disease
progression." He further stated, "These findings show that the use of this
endpoint to measure disease modifying anti-tumor therapies is a logical
surrogate to assess new anti-cancer agents in chemorefractory patients."
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
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"plans," "contemplate," "anticipates," "believes," "estimates," "predicts,"
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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
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