180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or the
“Company”), a clinical-stage biotechnology company, today announced
that a team led by researchers at University of Oxford have been
awarded a grant from the National Institute for Health and Care
Research (NIHR) in the U.K. to conduct a feasibility trial to
investigate whether anti-tumor necrosis factor (TNF) therapy,
administered at the time of surgery, can reduce or prevent post
operative delirium/cognitive deficit (“post-operative delirium”).
The research project is entitled, ‘WHiTE-DECI: World Hip Trauma
Evaluation – Delirium and Cognitive Impairment; a randomised
feasibility trial comparing severity of delirium symptomatology
between hip fracture patients 60 years and over treated with a
peri-operative infusion of anti-TNF or placebo’. University
reference: R77147, funded under the NIHR Research for Patient
Benefit (RfPB) Programme.
The trial is jointly funded by NIHR and 180 Life Sciences and is
expected to be open for enrollment in the first half of 2023. “This
is a major achievement by the team,” said Dr. Jim Woody, CEO of 180
Life Sciences. “These grants are awarded following a robust
peer-review process and are extremely competitive. It means that
the team will be able to access many services essential for the
conduct of the trial funded by the NIHR, and 180 Life Science is
delighted to be able to make a significant contribution to further
the trial. This dual funding model and collaboration between
academia and industry leverages the expertise of both to develop
new therapeutic strategies, for what we believe is a major unmet
medical need, in the most effective way to benefit patients in the
shortest possible timescale”.
Under a prior Memorandum of Understanding, the anti-TNF
infliximab, Remsima (a biosimilar of Remicade), approved for use in
the U.K., will be supplied for this trial by Celltrion Healthcare
UK Limited. The University of Oxford and Celltrion are currently
completing contract terms. As previously disclosed, an issued
patent to protect this potential use has been licensed by 180 Life
Sciences from The Kennedy Trust for Rheumatology Research. 180 Life
Sciences also has the rights for commercialization of the trial
results.
Post-operative delirium is an important problem, recognized as
the most common surgical complication in older adults.(1) According
to U.K. national audit data, 25% of all hip fracture patients
develop post-operative delirium. Hip fracture patients who develop
delirium are unfortunately twice as likely to die while in hospital
and nearly four times more likely to require nursing home care
compared with those who do not have delirium.(2) Patients who
develop delirium are approximately 4 times more likely to develop
cognitive memory deficit over 3 years, increasing to 8 fold higher
likelihood over 8 years.(3) There are approximately 70,000 hip
fractures each year in the U.K. and approximately 300,000 hip
fractures in the U.S. each year.(4)
Post-operative delirium can also occur following many other
types of surgery. For example, about 12% of older patients
undergoing elective surgery can be affected. According to the
Agency for Healthcare and Research Quality, there are approximately
450,000 hip replacements performed in the U.S. and 600,000 in the
EU each year and the majority of these patients are over the age of
65 years.
The Oxford team found that the trauma associated with surgery
leads to the release of proinflammatory mediators, especially TNF,
which in turn leads to inflammation of a part of the brain called
the hippocampus. The hippocampus is involved in memory and is
associated with learning and emotions.(5, 6)
Prof Sir Marc Feldmann, co-chairman of 180 Life Sciences said, "
It is a pleasure to see that 180 Life Sciences is following in my
past footsteps where, in the 1990s, I pioneered, the use of
anti-TNF in rheumatoid arthritis and 180 LS is now developing
a whole series of new uses for anti-TNF, a very effective and safe
medication.”
Professor Matt Costa at the University of Oxford, who will lead
the trial, is a trauma orthopedic surgeon with extensive expertise
in clinical trials especially in hip fracture, and will work
closely with Professor Nanchahal, the leader of the Oxford
scientific discovery efforts, and a clinical consultant for 180
Life Sciences.
The trial potentially fills an important unmet need which
affects a significant number of patients worldwide and will be
increasingly important preventative treatment as
the population ages. The study is designed as a multi-center,
randomized placebo-controlled trial to evaluate the feasibility of
a subsequent phase 3 trial in patients with hip fractures aged 60
years and above.
About 180 Life Sciences Corp.
180 Life Sciences Corp. is a clinical-stage biotechnology
company. The Company is driving groundbreaking studies into
clinical programs, which are seeking to develop treatments for
major unmet clinical needs. The Company’s primary platform is a
novel program to treat inflammatory disorders using anti-TNF (tumor
necrosis factor).
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and
affordable medications to promote patients’ access to advanced
therapies. Its products are manufactured at state-of-the-art
mammalian cell culture facilities, designed and built to comply
with the US FDA cGMP and the EU GMP guidelines. Celltrion
Healthcare endeavors to offer high-quality cost-effective solutions
through an extensive global network that spans more than 110
different countries.
About the National Institute for Health
and Care Research (NIHR), the research partner of the NHS, public
health and social careThe mission of the National
Institute for Health and Care Research (NIHR) is to improve the
health and wealth of the nation through research through:
- Funding high quality, timely research that benefits the NHS,
public health and social care;
- Investing in world-class expertise, facilities and a skilled
delivery workforce to translate discoveries into improved
treatments and services;
- Partnering with patients, service users, carers and
communities, improving the relevance, quality and impact of our
research;
- Attracting, training and supporting the best researchers to
tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry
to help shape a cohesive and globally competitive research
system;
- Funding applied global health research and training to meet the
needs of the poorest people in low and middle income
countries.
NIHR is funded by the Department of Health and Social Care. Its
work in low and middle income countries is principally funded
through UK Aid from the UK government.
Forward-Looking Statements
This press release includes "forward-looking statements",
including information about management’s view of the Company’s
future expectations, plans and prospects, within the safe harbor
provisions provided under federal securities laws, including under
The Private Securities Litigation Reform Act of 1995 (the “Act”).
Words such as “expect,” “estimate,” “project,” “budget,”
“forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,”
“should,” “believes,” “predicts,” “potential,” “continue” and
similar expressions are intended to identify such forward-looking
statements. These forward-looking statements involve significant
risks and uncertainties that could cause the actual results to
differ materially from the expected results and, consequently, you
should not rely on these forward-looking statements as predictions
of future events. These forward-looking statements and factors that
may cause such differences include, without limitation, statements
about the ability of our clinical trials to demonstrate safety and
efficacy of our product candidates, and other positive results; the
uncertainties associated with the clinical development and
regulatory approval of 180 Life Science’s drug candidates,
including potential delays in the enrollment and completion of
clinical trials; issues raised by the FDA and MHRA, timing to
complete required studies and trials, and timing to obtain
governmental approvals; the potential that earlier clinical trials
and studies may not be predictive of future results; 180 Life
Sciences’ reliance on third parties to conduct its clinical trials,
enroll patients, and manufacture its preclinical and clinical drug
supplies; the ability to come to mutually agreeable terms with such
third parties and partners, and the terms of such agreements;
estimates of patient populations for 180 Life Sciences planned
products; unexpected adverse side effects or inadequate therapeutic
efficacy of drug candidates that could limit approval and/or
commercialization, or that could result in recalls or product
liability claims; 180 Life Sciences’ ability to fully comply with
numerous federal, state and local laws and regulatory requirements,
as well as rules and regulations outside the United States, that
apply to its product development activities; the timing of filing,
the timing of governmental review, and outcome of, planned
Investigational New Drug (IND) applications for drug candidates;
current negative operating cash flows and a need for additional
funding to finance our operating plans; the terms of any further
financing, which may be highly dilutive and may include onerous
terms; statements relating to expectations regarding future
agreements relating to the supply of materials and license and
commercialization of products; the availability and cost of
materials required for trials; the risk that initial drug results
will not be able to be replicated in clinical trials or that such
drugs selected for clinical development will not be successful;
challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
the inherent risks in early stage drug development including
demonstrating efficacy; development time/cost and the regulatory
approval process; the progress of our clinical trials; our ability
to find and enter into agreements with potential partners; our
ability to attract and retain key personnel; changing market and
economic conditions; our ability to produce acceptable batches of
future products in sufficient quantities; unexpected manufacturing
defects; manufacturing difficulties and delays; competition,
including technological advances, new products and patents attained
by competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; expectations with respect to
future performance, growth and anticipated acquisitions; the
continued listing of the Company on The NASDAQ Stock Market;
expectations regarding the capitalization, resources and ownership
structure of the Company; expectations with respect to future
performance, growth and anticipated acquisitions; the ability of
the Company to execute its plans to develop and market new drug
products and the timing and costs of these development programs;
estimates of the size of the markets for its potential drug
products; the outcome of current litigation involving the Company;
potential future litigation involving the Company or the validity
or enforceability of the intellectual property of the Company;
global economic conditions; geopolitical events and regulatory
changes; the expectations, development plans and anticipated
timelines for the Company's drug candidates, pipeline and programs,
including collaborations with third parties; access to additional
financing, and the potential lack of such financing; and the
Company’s ability to raise funding in the future and the terms of
such funding. These risk factors and others are included from time
to time in documents the Company files with the Securities and
Exchange Commission, including, but not limited to, its Form 10-Ks,
Form 10-Qs and Form 8-Ks, and including the Annual Report on Form
10-K for the year ended December 31, 2021 and Quarterly Report on
Form 10-Q for the quarter ended March 31, 2022, and future SEC
filings. These reports and filings are available at www.sec.gov and
are available for download, free of charge, soon after such reports
are filed with or furnished to the SEC, on the “Investors”—“SEC
Filings”—“All SEC Filings” page of our website at
www.180lifesciences.com. All subsequent written and oral
forward-looking statements concerning the Company, the results of
the Company’s clinical trial results and studies or other matters
and attributable to the Company or any person acting on its behalf
are expressly qualified in their entirety by the cautionary
statements above. Readers are cautioned not to place undue reliance
upon any forward-looking statements, which speak only as of the
date made, including the forward-looking statements included in
this press release, which are made only as of the date hereof. The
Company cannot guarantee future results, levels of activity,
performance or achievements. Accordingly, you should not place
undue reliance on these forward-looking statements. The Company
does not undertake or accept any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statement to reflect any change in its expectations or any change
in events, conditions or circumstances on which any such statement
is based, except as otherwise provided by law.
Investors:Jason AssadDirector of IR180 Life Sciences Corp(678)
570-6791Jason@180lifesciences.com
Media Relations:Russo PartnersDavid
SchullDavid.Schull@russopartnersllc.com (212)
845-4271
1. NAFHD annual report,
https://www.nhfd.co.uk/2018report.
(2018).2. A. Alam, Z. Hana, Z.
Jin, K. C. Suen, D. Ma, Surgery, neuroinflammation and cognitive
impairment. EBioMedicine 37, 547-556
(2018).3. H. Huang et al.,
Association of postoperative delirium with cognitive outcomes: A
meta-analysis. J Clin Anesth 75, 110496
(2021).4. O. Johnell, J. A.
Kanis, An estimate of the worldwide prevalence, mortality and
disability associated with hip fracture. Osteoporos Int
15, 897-902
(2004).5. M. Cibelli et al.,
Role of interleukin-1beta in postoperative cognitive dysfunction.
Ann Neurol 68, 360-368
(2010).6. N. Terrando et al.,
Tumor necrosis factor-alpha triggers a cytokine cascade yielding
postoperative cognitive decline. Proc Natl Acad Sci U S A
107, 20518-20522 (2010).
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