XBiotech Announces Agreement with Cedars-Sinai Medical Center to Evaluate MABp1 in Combination with Onivyde® and 5-fluoroura...
September 20 2017 - 8:00AM
YASTEST
AUSTIN, Texas, Sept. 20, 2017
(GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today its
agreement with Cedars-Sinai Medical Center located in Los Angeles,
California, whereby XBiotech will provide its interleukin-1 alpha
antagonist, MABp1, for a Phase I single arm study evaluating the
maximum tolerated dose of Onivyde® (Irinotecan liposome
injection) and 5-fluorouracil/folinic acid in combination with
MABp1 in a cohort of patients with advanced pancreatic
adenocarcinoma and cachexia. The study will also assess efficacy
using various secondary measures including changes in lean body
mass, weight stability, IL-6 levels, overall and progression free
survival as well as evaluation of the relationship between
treatment tolerance and patient functional status.
Andrew Hendifar, M.D., Medical
Oncology lead for the Gastrointestinal Disease Research Group at
Cedars-Sinai and Co-Director of Pancreas Oncology, will be leading
the study which is planned to enroll a total of 16 patients at the
Cedars-Sinai Medical Center. Onivyde will be given intravenously
with MABp1 and 5-fluorouracil/folinic acid every two weeks
until disease progression.
Dr. Hendifar commented, "The
results to date with treatment of MABp1 show much promise as an
effective therapy in this setting. I look forward to evaluating
this combination therapy to determine its safety and clinical
benefit."
Despite decades of clinical
trials, the prognosis for advanced pancreatic cancer is poor [1].
The 5-year survival has remained close to 5% and unchanged
despite improvements in chemotherapeutics, surgical outcomes, and
diagnostic techniques [1, 2]. Advanced pancreatic
adenocarcinoma is characterized by progressive weight loss and
nutritional deterioration [3]. It is estimated that up to 80%
of these patients present with cachexia [4]. This syndrome
has been linked not only to survival, but also to alterations in
host defenses, functional ability, and quality of life. In a Phase
III clinical study, MABp1 was found to improve clusters of symptoms
that included reduced pain, fatigue, improved appetite and
increased lean body mass. Patients that had these improvements were
found to have reduced disease progression and serious adverse
events, and about a three-fold improvement in survival.
Other than multi-agent cytotoxic
therapy there have been no treatment advances for pancreatic cancer
or its associated cachexia. Despite the availability of effective
chemotherapy, only between 15-40% of pancreatic cancer patients are
able to receive second line treatment. Importantly, cachexia and
its associated fatigue and deconditioning, may explain the
difficulty in providing continued therapy after progression in the
first-line. It is hoped that MABp1 used in combination with Onivyde
will help control disease, reduce symptoms and allow patients to
receive treatment longer, thereby improving outcomes.
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@xbiotech.com
512-386-2930
1. Li, D., et al., Pancreatic cancer. Lancet,
2004. 363(9414): p.
1049-57.
2. Panagiotarakou, M., et al., Use of
supportive care for symptom management in pancreatic cancer:
application of clinical research to patient care. Jop,
2012. 13(4): p.
342-4.
3. Splinter, T.A., Cachexia and cancer: a
clinician's view. Ann Oncol, 1992. 3 Suppl 3: p. 25-7.
4. Ryan, D.P. and M.L. Grossbard, Pancreatic
Cancer: Local Success and Distant Failure. Oncologist,
1998. 3(3): p. 178-188.
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The issuer of this announcement warrants that they are solely
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information contained therein.
Source: XBiotech, Inc via Globenewswire
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