Adamis Pharmaceuticals Announces Tempol Reduces Lung Inflammation in the COVID-19 Challenged Hamster Model
15 Marzo 2021 - 7:00AM
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) ("Company")
announced today that in studies conducted at Galveston National
Laboratory (GNL), University of Texas Medical Branch (UTMB) at
Galveston, hamsters challenged with the virus that causes COVID-19
(SARS-CoV-2), resulted in decreased inflammation in the lungs of
animals treated with Tempol compared to controls. This is the first
data demonstrating that Tempol, a novel antioxidant, can reduce
inflammation in animals given the virus (SARS-CoV-2) that causes
COVID-19. The group plans on submitting the publication to a peer
review journal.
Dr. Chien-Te Kent Tseng, Professor of 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 COVID-19 model, pulmonary inflammation with
cellular infiltrates and hemorrhage (mild-to-moderate) is triggered
by SARS-CoV-2 infection. Treatment with Tempol reduces the overall
inflammatory responses and appears to start repairing damaged
lungs.”
These results are also consistent with the results that the
Company announced regarding in-vitro cytokine data from Stanford
University. The results demonstrated that incubation of Tempol
significantly suppresses multiple inflammatory cytokines from cells
taken from COVID-19 patients.
Tempol has demonstrated both potent anti-inflammatory,
anticoagulant, and antioxidant activity. Both inflammatory
cytokines and reactive oxygen species (ROS) from cells of the
immune system called macrophages and neutrophils damage the lung in
Acute Respiratory Distress Syndrome (ARDS). Tempol has now been
shown to: (1) Decrease the proinflammatory cytokines (cytokine
storm) in animal models (lipopolysaccharide induced), (2) Suppress
cytokines in stimulated COVID-19 positive human cells, and (3)
Reduce inflammation in hamsters challenged with COVID-19. In
addition, Tempol has been shown to decrease platelet aggregation, a
problem observed in many COVID-19 patients.
The new results demonstrating decreased lung inflammation in
hamsters challenged and treated with Tempol are consistent with the
design of the recent FDA allowed IND and protocol to study Tempol
in early COVID-19 infection. The goal of the study titled, “A Phase
2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study
to Examine the Effects of Tempol (MBM-02) on Preventing COVID-19
Related Hospitalization in Subjects with COVID-19 Infection” is to
examine the safety and activity of Tempol in COVID-19 patients
early in the infection. In addition to safety, the study will
examine markers of inflammation and the rate of hospitalization for
patients taking Tempol versus placebo early in COVID-19 infection.
More details of the protocol can be found here or by searching
Clinicaltrials.gov. Dr. Ronald Moss, Chief Medical Officer of
Adamis, commented: “These results from a validated animal model for
COVID-19 provide further support on implementing our well-designed
clinical trial in order to obtain activity and safety information
on the use of Tempol in early COVID-19 infection in humans.”
Dr. Dennis J. Carlo, President and Chief Executive Officer of
Adamis Pharmaceuticals, commented: “The results to date support the
design of our clinical study in that we are targeting early
infection with the objective of reducing lung inflammation and
eventual hospitalization. We are hopeful that the clinical study
will replicate the results obtained to date, i.e., preventing or
ameliorating some of the most severe symptoms of COVID-19 caused by
dysfunctional inflammation.”
In addition to Dr. Tseng, the UTMB team includes Drs. Aleksandra
K. Drelich, Kempaiah Rayavara Kempaiah, and Bi-Hung Peng
(Pathologist).
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. Adamis’ 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. The company’s subsidiary,
US Compounding Inc., compounds sterile prescription drugs, and
certain nonsterile drugs for human and veterinary use by hospitals,
clinics, surgery centers, and vet clinics throughout most of the
United States. 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 company’s beliefs concerning the safety and
effectiveness of Tempol or the company’s other product candidates;
the timing of commencement or completion of studies or trials
relating to Tempol; the results of any studies or trials that the
company may conduct relating to Tempol; the company’s ability to
commercialize the product candidates described in this press
release, itself or through commercialization partners; and other
statements concerning our 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 of commencement of trials relating
to Tempol, the timing of completion of such trials or the outcome
of such trials, that the company’s planned Phase 2/3 study will
produce results that are consistent with earlier preclinical or
clinical studies or trials 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 most recent
annual report on Form 10-K 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 AdamisMark FlatherSenior Director,
Investor Relations& Corporate CommunicationsAdamis
Pharmaceuticals Corporation(858)
412-7951mflather@adamispharma.com
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