XBiotech Announces First Patient in Study Evaluating MABp1 in Combination with Onivyde® and 5-fluorouracil/folinic acid for ...
19 October 2017 - 1:53AM
YASTEST
AUSTIN, Texas, Oct. 18, 2017
(GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today
enrollment of the first patient into 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 patient has begun treatment at
Cedars-Sinai Medical Center under the care of Dr. Andrew Hendifar,
the Study's Principle Investigator, Medical Oncology lead for the
Gastrointestinal Disease Research Group and Co-Director of Pancreas
Oncology at Cedars-Sinai. A total of 16 patients are expected to be
enrolled in the study.
Dr. Hendifar commented, "We are
excited to enroll our first patient in this novel combinatorial
therapy for the treatment of advanced pancreatic cancer and
cachexia. This is the first attempt to add an anti-inflammatory
therapy to standard chemotherapy in an effort to improve the
performance, quality of life, and survival in patients with this
disease."
The study will also assess overall
and progression free survival as well as evaluate the relationship
between treatment tolerance and patient functional status. Various
secondary measures, including changes in lean body mass, weight
stability and levels of systemic inflammation will also be
monitored. Onivyde will be given intravenously with MABp1 and
5-fluorouracil/folinic
acid every two weeks until disease progression.
The prognosis for advanced
pancreatic cancer remains poor despite decades of studies
[1]. The 5-year survival has remained close to 5%, unchanged
despite improvements in chemotherapeutics, surgical outcomes, and
diagnostic techniques [1, 2]. Other than multi-agent
cytotoxic therapy there have been no treatment advances for
pancreatic cancer or its associated cachexia.
MABp1 was found to improve
clusters of symptoms that included reduced pain, fatigue, improved
appetite and increased lean body mass in advanced cancer patients.
Patients that had these improvements were found to have less tumor
progression, substantial reduced serious adverse events related to
disease, and about a three-fold improvement in survival [3].
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
- Li, D., et al., Pancreatic cancer. Lancet,
2004. 363(9414): p. 1049-57.
- 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.
- Hickish T., et al., MABp1 as
a novel antibody treatment for advanced colorectal cancer:
a randomised, double-blind, placebo-controlled, phase 3 study. Lancet
Oncol. 2017 Feb;18(2):192-201.
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
XBiotech (NASDAQ:XBIT)
Historical Stock Chart
From Apr 2024 to May 2024
XBiotech (NASDAQ:XBIT)
Historical Stock Chart
From May 2023 to May 2024