XBiotech Announces First Patient in Study Evaluating MABp1 in Combination with Onivyde® and 5-fluorouracil/folinic acid for the Treatment of Pancreatic Cancer
(Thomson Reuters ONE) -
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(at)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. 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
Unternehmensinformation / Kurzprofil:
Datum: 18.10.2017 - 16:53 Uhr
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