Adamis Pharmaceuticals Provides Update on Clinical Study Assessing Tempol for the Treatment of COVID-19
June 01 2022 - 8:00AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a
biopharmaceutical company developing and commercializing specialty
products for allergy, opioid overdose, respiratory and inflammatory
diseases, today announced that a meeting of the Data Safety
Monitoring Board (DSMB) overseeing the Company’s Phase 2/3 clinical
trial investigating the use of Tempol for the treatment of
COVID-19, was held on May 31 to evaluate interim clinical and
safety data for the trial. The DSMB is composed of subject matter
experts and can unblind the data to determine the treatment effects
of the subjects in the trial. Based on an interim review of the
data, the DSMB determined that the study can continue as planned.
“We look forward to the completion and final analysis of this
important clinical trial,” said David J. Marguglio, Chief Executive
Officer of Adamis Pharmaceuticals. “We appreciate the timely
feedback from the DSMB as COVID-19 remains a serious public health
problem with recent spikes in infections due to omicron and other
variants. Additional therapeutic options are needed for outpatient
treatment of COVID-19.”
The Company previously announced the results of a published
study in collaboration with Stanford University researchers,
suggesting that Tempol has strong, broad in-vitro anti-cytokine
activity. In addition, the Company previously announced that in an
animal SARS-COV2 challenge model, a decrease in inflammation was
noted in the lungs of animals given Tempol compared to control
animals.
About the Tempol Phase 2/3 Trial
Additional information about the trial can be found on
www.clinicaltrials.gov using the identifier NCT04729595. Adamis has
licensed exclusive worldwide rights under certain patents, patent
applications and related know-how relating to Tempol for certain
licensed fields including the treatment of respiratory diseases
including asthma, respiratory syncytial virus, influenza and
COVID-19, and for the reduction of radiation-induced dermatitis in
patients undergoing treatment for cancer.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company primarily focused on developing and
commercializing products in various therapeutic areas, including
allergy, opioid overdose, respiratory and inflammatory disease. The
Company’s SYMJEPI® (epinephrine) Injection products are
approved by the FDA for use in the emergency treatment of acute
allergic reactions, including anaphylaxis. The
Company’s ZIMHI™ (naloxone) Injection product is approved
for the treatment of opioid overdose. Tempol is in development for
the treatment of patients with COVID-19 and a Phase 2/3 clinical
trial is underway. For additional information about Adamis
Pharmaceuticals, please visit our website and follow us
on Twitter.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those that express
plans, anticipation, intent, contingencies, goals, targets or
future development and/or otherwise are not statements of
historical fact. These statements relate to future events or future
results of operations, including, but not limited to the following
statements: statements concerning the Company’s Phase 2/3 clinical
trial for Tempol; statements concerning the activities and process
of the DSMB and the timing and outcome of that process; the
Company’s beliefs concerning the mechanisms of action, safety and
effectiveness of Tempol and that Tempol addresses an unmet medical
need; the timing, progress or results of the Company’s Phase 2/3
clinical trial for Tempol or other studies or trials relating to
Tempol; the Company's beliefs concerning the ability of its
products and product candidates to compete successfully in the
market; the Company’s beliefs concerning the benefits,
enforceability, and extent of intellectual property rights and
protection afforded by patents and patent applications that it owns
or has licensed, including those relating to Tempol; the Company’s
ability to successfully commercialize the products and product
candidates, itself or through commercialization partners; the
Company’s ability to enter into new collaborations and partnerships
and create long-term value for patients, providers and
stockholders; and other statements concerning the Company’s future
operations and activities. These statements are only predictions
and involve known and unknown risks, uncertainties, and other
factors, which may cause Adamis’ actual results to be materially
different from the results anticipated by such forward-looking
statements. There are no assurances concerning the amount of time
that the DSMB will take to conduct or complete any future analyses
or reviews or concerning the results or outcome of that analysis.
There can be no assurances regarding the timing, progress or
outcome of trials or studies relating to Tempol, or that Tempol
will be found to be safe and effective in the treatment of COVID-19
or any other indication. In addition, forward-looking statements
concerning our anticipated future activities assume that we have
sufficient funding to support such activities and continue our
operations and planned activities. Statements in this press release
concerning future events depend on several factors beyond the
Company's control, including the absence of unexpected developments
or delays, market conditions, and the regulatory approval process.
We cannot assess the impact of each factor on our business or the
extent to which any factor, or combination of factors, may cause
actual results to differ materially from those contained in any
forward-looking statements. You should not place undue reliance on
any forward-looking statements. Further, any forward-looking
statement speaks only as of the date on which it is made, and
except as may be required by applicable law, we undertake no
obligation to update or release publicly the results of any
revisions to these forward-looking statements or to reflect events
or circumstances arising after the date of this press release.
Certain of these risks and additional risks, uncertainties, and
other factors are described in greater detail in Adamis’ filings
from time to time with the SEC, including its annual report on
Form 10-K for the year ended December 31, 2021, and subsequent
filings with the SEC, which Adamis strongly urges you to read
and consider, all of which are available free of charge on
the SEC's web site at http://www.sec.gov.
Contacts
Adamis Investor RelationsRobert UhlManaging
DirectorICR Westwicke619.228.5886robert.uhl@westwicke.com
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