Adamis Pharmaceuticals Announces a Publication with the Human Immune Monitoring Center at Stanford Demonstrating Tempol Significantly Inhibited Multiple Cytokines from COVID-19 Patient’s Cells
24 Agosto 2021 - 8:30AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced a
publication in the peer reviewed journal, Clinical Immunology,
entitled “Tempol, a novel antioxidant, inhibits both activated T
cell and APC (Antigen Presenting Cell) derived cytokines in-vitro
from COVID-19 patients”
(https://www.sciencedirect.com/journal/clinical-immunology/articles-in-press).
The studies conducted at the Human Immune Monitoring Center at
Stanford University investigated the effects of Tempol, an
investigational drug, on immune cells from COVID-19 patients. The
authors conclude “Preincubation of immune cells with Tempol
resulted in a significant (P<0.05) decrease in multiple T cell
and APC-derived cytokines from both cells of COVID-19 and
uninfected donors. These results suggest that Tempol has strong
in-vitro anti-cytokine activity and supports additional studies
examining the use of Tempol for the treatment of COVID-19.”
Dr. Holden Maecker, Director of the Human Monitoring Center at
Stanford University commented: “These results suggest that Tempol
has strong, broad in-vitro anti-cytokine activity. Suppression of
inflammatory cytokines with an antioxidant may be a beneficial
strategy in early COVID-19 infection.”
Inflammatory cytokines and reactive oxygent species (ROS such as
O*2 -) from cells of the immune system called macrophages and
neutrophils damage the lung in Acute Respiratory Distress Syndrome
(ARDS). In animal models, Tempol has been shown to decrease
proinflammatory cytokines (cytokine storm) and lung inflammation.
In additon, Tempol works as an antixodant and has demonstrated
decreasing harmful ROS. In addition, Tempol has been shown to
decrease platelet aggregration, a problem observed in many COVID-19
patients.
Recently, the National Institutes of Health (NIH) highlighted
Tempol as a potential home treatment for COVID-19
(https://covid19.nih.gov/news-and-stories/tempol-potential-home-treatment-covid-19).
The NIH news stated that, “This treatment would likely prevent
severe disease.” Recent studies conducted by NIH researchers
suggested that Tempol has potent antiviral activity against the
virus that causes COVID-19 in laboratory studies. The NIH news
article further describes how Tempol could possibly reduce COVID-19
symptoms by calming inflammation, protecting organs from damage,
and decreasing the clumping of platelets. The U.S. Food & Drug
Administration has given the go-ahead to Adamis Pharmaceuticals to
conduct a clinical study using Tempol as an at home treatment to
prevent disease progression and thereby releasing the burden of
COVID-19 on the healthcare system. Adamis plans to initiate a
randomized placebo-controlled study shortly.
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis, commented: “Tempol’s significant activities, such as
decreasing inflammation in the lungs, protecting organs such as the
heart from damage, inhibiting blood clotting and lowering viral
burden, all make it an ideal candidate for the home treatment of
COVID-19. Tempol is safe and it does not come with the side effects
or adverse events associated with gene vaccination. In addition,
its mechanism of action lends it to having activity independent of
any new COVID-19 variants. Even though Israel is the model country
for almost everyone being vaccinated, there are significant
increases in breakthroughs and hospitalizations occurring in
vaccinated individuals. Tempol may very well be in a unique
position and may prove to be a very important “medical tool” in the
treatment of COVID-19. In addition to COVID-19, Tempol might very
well be used to treat other viral respiratory infections including
influenza and respiratory syncytial virus.”
Adamis has previously licensed exclusive worldwide rights under
patents, patent applications and related know-how to use Tempol for
the treatment of respiratory diseases including asthma, respiratory
syncytial virus, influenza and COVID-19.
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 resubmitted New
Drug Application (NDA) for its naloxone injection product
candidate, ZIMHI, for the treatment of opioid overdose. is
currently under FDA review. Adamis is developing additional
products, including treatments for acute respiratory diseases, such
as COVID-19, influenza, asthma, and COPD. For additional
information about Adamis Pharmaceuticals, please visit
www.adamispharmaceuticals.com.
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: the opinions and beliefs of NIH researchers summarized
in the NIH article discussed in this press release concerning the
potential of Tempol as a treatment for COVID-19 and the results of
previous studies of Tempol; the Company’s beliefs concerning the
safety and effectiveness of Tempol or the Company’s other product
candidates; the timing, progress or results of the Company’s Phase
2/3 clinical trial for Tempol or other studies or trials relating
to Tempol; funding for clinical trials relating to Tempol and the
Company’s ability to receive any government funding relating to
clinical development, studies or trials relating to 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; 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. There are no
assurances that the Company will receive any government funding
relating to clinical investigations, development or trials relating
to Tempol or concerning the timing, amount of, or terms and
conditions relating to, any such governmental funding that might be
received. In addition, as previously disclosed, each of the Company
and its US Compounding Inc. subsidiary has received a subpoena from
the U.S. Attorney’s Office for the Southern District of New York
issued in connection with a criminal investigation. Accordingly,
all forward-looking statements are subject to the outcome of this
investigation and any related governmental investigations or
proceedings, as well as the related internal investigation being
conducted by the Company’s Audit Committee. 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 DirectorWestwicke
ICR 619.228.5886robert.uhl@westwicke.com
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