180 Life Sciences Announces Publication of a Review on the Treatments for Early Stage Dupuytren’s Disease
January 25 2023 - 8:45AM
180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or the
“Company”), today announced the publication of a review entitled
‘Treatments for early stage Dupuytren’s disease: an evidence-based
approach’ in The Journal of Hand Surgery (European Volume).
In the publication, Professor Jagdeep Nanchahal,
chairman of the medical advisory board of 180 Life Sciences, and
his colleague at the University of Oxford, describe the limitations
for the current treatments for late-stage Dupuytren’s disease and
the lack of evidence based on randomized double blind,
placebo-controlled trials for treatments for early-stage disease,
such as intranodular injection of steroid or radiotherapy. They go
on to describe how tumor necrosis factor (TNF) was identified as a
potential therapeutic target through the study of cellular
signaling mechanisms in tissue from patients. They also describe
the results of the phase 2a dose ranging trial, which identified
the most efficacious dose and formulation of adalimumab (an
anti-TNF). This was followed by a phase 2b trial, which met the
primary endpoint of reduction in nodule hardness and the secondary
endpoint of decrease in nodule size, indicating the potential to
control progression of early-stage disease.
Professor Marc Feldmann FRS, co-chairman of 180
Life Sciences said, “This review in a pre-eminent journal in the
field summarizes the evidence for current treatments for
early-stage Dupuytren’s disease based on systematic reviews of the
literature and the advances made in the field by Professor
Nanchahal and his team at the University of Oxford.”
Dr. James Woody, CEO of 180 Life Sciences,
stated, “We look forward to advancing the laboratory and clinical
findings that support the potential for anti-TNF to treat the large
number of patients with early-stage Dupuytren’s disease.”
About 180 Life Sciences
Corp.
180 Life Sciences Corp. is a clinical-stage
biotechnology company driving ground-breaking studies into clinical
programs which are seeking to address major unmet medical needs.
The Company’s focus is a novel program to treat several
inflammatory disorders using anti-TNF (tumor necrosis factor).
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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
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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
regarding the timing of our planned marketing authorization
application (MAA) submission to the UK Medicines and Healthcare
products Regulatory Agency (MHRA), our ability to obtain approval
and acceptance thereof, the willingness of MHRA to review such MAA,
and our ability to address outstanding comments and questions from
the MHRA; 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 Sciences’
drug candidates, including potential delays in the enrollment and
completion of clinical trials, issues raised by the U.S. Food and
Drug Administration (FDA) and MHRA; the ability of the Company to
persuade MHRA that chosen endpoints do not require further
validation; timing to complete required studies and trials, and
timing to obtain governmental approvals; the accuracy of
simulations and the ability to reproduce the outcome of such
simulations in real world trials; 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, increases in
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increased inflation which may negatively affect costs, expenses and
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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
are not predictive of future results or 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’s securities 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; and the effect of rising interest rates and
inflation, and economic downturns and recessions. 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 September 30, 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
CorpJassad@180lifesciences.com
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