XBiotech Announces First Patient in Study Evaluating MABp1 in Combination with OnivydeⓇ and 5-fluorouracil/folinic acid for...
October 18 2017 - 10:41AM
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™ 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.
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materially from the forward-looking statements contained in this
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ContactAshley
Oteroaotero@xbiotech.com512-386-2930
- 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.
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