Adamis Pharmaceuticals Cleared to Proceed with Human Studies of Tempol for the Treatment of COVID-19
February 22 2021 - 9:00AM
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP)
("Company") announced today that the U.S. Food and Drug
Administration (“FDA”) has completed the safety review of the
Company’s Investigational New Drug (“IND”) application and has
concluded that Adamis may proceed with the proposed clinical
investigation of Tempol for the treatment of COVID-19. The
clearance to proceed follows the submission of an IND application
to FDA and a Pre-IND meeting.
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.
“As the principal investigator of this study, I am excited to
initiate this clinical trial to evaluate the role of Tempol to
prevent serious complications and hospitalization in COVID-19
patients. We are in need of additional therapeutic options for
COVID-19, and this novel antioxidant approach deserves a thorough
investigation,” noted Shyam Kottilil, MBBS, PhD, Professor of
Medicine and Director of the Division of Clinical Care and Research
at the Institute of Human Virology at the University of Maryland
School of Medicine.
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). In animal models,
Tempol has been shown to decrease proinflammatory cytokines
(cytokine storm), and through its potent antioxidant activity has
been shown to decrease the harmful effects of ROS. In addition,
Tempol has been shown to decrease platelet aggregation, a problem
observed in many COVID-19 patients.
Recently, in collaboration with investigators at the Human
Immune Monitoring Center at Stanford University, preliminary
data from a study to investigate the effects of Tempol on immune
cells from COVID-19 patients showed that Tempol decreased cytokine
production in stimulated COVID-19 positive human cells. Numerous
published articles describing animal models of ARDS show Tempol
caused a decrease in lung inflammation and preserved lung pathology
associated with acute and chronic lung injury.
Tempol has also been shown to have an impact on gene expression.
Examples include:
(1) Glutathione s-transferase, regulators of
oxidative stress - Tempol has been shown to significantly increase
the enzyme gene expression, thereby protecting cells against the
onslaught of oxidative stress from numerous
sources;(2) ADIPOQ gene, an inflammation
regulatory gene - Tempol has been shown to significantly increase
expression of ADIPQ, thereby regulating the expression of
pro-inflammatory cytokines such as TNF∝ and IL-6;
and(3) HIF-1∝ and HIF-2∝, hypoxia inducible
factors - Tempol has been shown to decrease the genes (HIF1∝ and
HIF-2∝) associated with hypoxia. Hypoxia is a key indicator often
associated with severe disease and poor outcome. Controlling
hypoxia and the cytokine store can be considered essential to the
successful treatment of COVID-19.Dr. Dennis J. Carlo, President and
Chief Executive Officer of Adamis Pharmaceuticals commented: “With
new mutations of COVID-19 continuing to occur, there is a distinct
possibility that the current vaccines will be less effective. This
also holds true for the current antibody products. As the virus
continues to mutate, it is likely that this will have a negative
impact on viral neutralization. This highlights how critically
important it is to develop new therapeutic products. The
consequences of cytokine storm caused by COVID-19 remain a major
burden on our healthcare system, with few treatment options
available. We are hopeful that this study will demonstrate the
important role of Tempol in treating and preventing hospitalization
and the severe after effects of COVID-19. If this trial is
successful, we would likely petition the FDA to consider Emergency
Use Authorization for Tempol as a therapeutic treatment for
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. 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; the timing of commencement of enrollment
of patients, conduct or completion of any studies or trials
relating to Tempol including the trial discussed in this press
release; the results of any studies or trials that the company may
conduct relating to Tempol; the impact of Tempol on gene
expression; the company’s ability to commercialize the product
candidates described in this press release, itself or through
commercialization partners; the effectiveness of current or future
COVID-19 vaccine products against new mutations of COVID-19; 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 patient
enrollment for trials or studies relating to Tempol, or regarding
the timing of the conduct and completion of such clinical trials;
that the Tempol trial discussed in this press release will be
successful; that future trials or studies regarding Tempol will
produce results regarding the impact of Tempol of gene expression
or other results that are consistent with the results in previous
studies or trials; that Tempol will be found to be safe and
effective in the treatment of COVID-19 or any other indication;
that we will apply for or that the FDA will grant any emergency use
authorization for Tempol for Tempol as a therapeutic treatment for
COVID-19; or regarding the effectiveness of current or future
COVID-19 vaccine products against new mutations of COVID-19. 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, 2019 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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