Medical Research Council Funds Phase 2 Multi-Center Study of XBiotech’s Bermekimab in Advanced Cancer Patients
July 09 2019 - 8:00AM
Medical Research Council Funds Phase 2 Multi-Center Study of
XBiotech’s Bermekimab in Advanced Cancer Patients
XBiotech (NASDAQ: XBIT) announced today that the Medical Research
Council (MRC), part of UK Research and Innovation, has awarded
funding to study bermekimab therapy in a Phase 2 multi-center study
in advanced cancers. The MRC will provide funding for all clinical
costs of the Phase 2 study to treat patients with advanced lung,
pancreatic and ovarian cancers. The MRC uses leading medical
researchers to evaluate and award grants based on the mission “to
improve human health through world-class medical research.”
[https://mrc.ukri.org/]
The phase 2 study will be conducted at multiple
cancer centers across the UK. Patients will receive eight weekly
doses of bermekimab and be assessed for tumor-related wasting and
other quality of life symptoms (using the EORTC QLQ-C30). The study
was developed in conjunction with the National Institute for Health
Research (NIHR) Cancer & Nutrition Collaboration and the
National Cancer Research Institute (NCRI) Supportive and Palliative
Care Group.
Barry J. A. Laird, M.D., Senior Lecturer in
Palliative Medicine at the University of Edinburgh’s Cancer
Research Centre, Institute of Genetics and Molecular Medicine, and
Consultant in Palliative Medicine at St Columba’s Hospice in
Edinburgh will head the study. Dr. Laird commented, “In patients
with cancer, loss of weight, decreased activity and impaired
quality of life are often regarded as inevitable with limited
treatments available. Using immunotherapy to abrogate this disease
process is a new approach. We are grateful to the MRC and to
XBiotech for supporting this trial.”
John Simard, President & CEO of XBiotech,
commented, “We are pleased that the medical experts at the MRC have
committed resources to the bermekimab program in oncology. We are
grateful to Dr. Baird for his work in advancing a novel clinical
protocol and for bringing this important immunotherapy to patients
in the UK. Bermekimab has proven to significantly benefit patients
with advanced cancer. We are eager to provide bermekimab in support
of the planned clinical study and to help patients suffering from
advanced cancer.”
Bermekimab targets the inflammatory cytokine
interleukin-1a and has been used in other innovative oncology
studies. The Company previously met its primary endpoint in a
randomized double-blind, placebo-controlled study with bermekimab
for the treatment of advanced colorectal cancer. The primary
endpoint in the study was a novel symptom cluster, which assessed a
combination of physical symptoms—pain, fatigue, anorexia and muscle
wasting—that are key measures of patient quality of life and
predictors of survival. Patients treated with bermekimab were
significantly more likely to achieve the primary endpoint compared
to placebo (33% vs 17%, respectively); moreover, patients who
achieved the primary endpoint had one-fifth as many serious adverse
events, were twice as likely to have stable disease (according to
RECIST criteria), showed significant and clinically relevant
improvement in all life quality measures, and had almost three-fold
increase in survival compared to failures.
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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ContactAshley
Oteroaotero@xbiotech.com512-386-2930
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