Adamis Pharmaceuticals Announces Results of Tempol in Omicron Virus Challenge in Hamster Model
22 Marzo 2022 - 5:30AM
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today
announced that in studies conducted at Galveston National
Laboratory (GNL), University of Texas Medical Branch (UTMB) at
Galveston, hamsters challenged with high levels of the Omicron
variant of the SARS-CoV-2 virus, resulted in significant decrease
of inflammation in the lungs of animals treated with Tempol
compared to controls. The Company previously reported data
demonstrating that Tempol, a novel antioxidant, can reduce
inflammation in hamsters given the original non-variant wild-type
virus (SARS-CoV-2) strain that causes COVID-19.
Dr. Chien-Te Kent Tseng, Professor in the Department of
Microbiology and Immunology and Director of GNL’s
SARS/MERS/COVID-19 Laboratory at UTMB, commented on these results:
“In our hamster model using high doses of omicron virus, we observe
significant pulmonary inflammation. In contrast, animals given
Tempol show a significant reduction of inflammation. Tempol acts as
a potent anti-inflammatory in the hamster challenge model, which we
believe is an appropriate model for human COVID-19.” In addition to
Dr. Tseng, the UTMB team includes Drs. Aleksandra K. Drelich and
Bi-Hung Peng (Pathologist).
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis Pharmaceuticals commented: “The new Omicron variant BA.2 is
predicted to increase in the US over the next few weeks. The
Centers for Disease Control and Prevention data show BA.2, which is
a subvariant of omicron, has been tripling in prevalence every two
weeks. The recent Tempol animal study shows significant decrease in
lung inflammation in hamsters given high doses of Omicron. It is
encouraging since we have seen similar effects in the wild type
unmutated virus. The ongoing evolutionary changes of the virus
create challenges for vaccines and there are limited safe treatment
options against these new variants. These data support the
potential for Tempol to play an important role, as a medical
countermeasure, to the ongoing evolutionary changes in the virus
that causes COVID-19. The animal study results to date also support
the design of our ongoing clinical study in humans where we are
targeting early infection with the objective of reducing
inflammation and a more rapid resolution of symptoms. We are
hopeful that the clinical study will replicate the animal study
results, i.e., preventing or ameliorating some of the most severe
symptoms of COVID-19 caused by dysfunctional inflammation,
regardless of the virus variant.”
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 Adamis.com
and follow us on Twitter and LinkedIn.
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 variants of COVID-19; statements
concerning the GNL animal study results using Tempol; the Company’s
beliefs concerning the mechanisms of action, safety and
effectiveness of Tempol; the timing, progress or results of the
Company’s Phase 2/3 clinical trial for Tempol or other studies or
trials relating to Tempol as a treatment for COVID-19; the opinions
and beliefs of any third parties identified in this press release
concerning the potential of Tempol as a treatment for COVID-19 and
the results of previous animal studies of Tempol; the Company’s
ability to commercialize the product candidates described in this
press release, itself or through commercialization partners; 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; 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 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. 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, 2020 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.
Contact:
Adamis Investor RelationsRobert UhlManaging DirectorICR
Westwicke 619.228.5886robert.uhl@westwicke.com
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