XBiotech Announces Agreement with Cedars-Sinai Medical Center to Evaluate MABp1 in Combination with OnivydeⓇ and 5-fluorour...
September 20 2017 - 8:00AM
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™ Therapeutic
AntibodiesXBiotech’s True Human™ 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™ 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
StatementsThis 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,"
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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.
ContactAshley
Oteroaotero@xbiotech.com512-386-2930
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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