Tempol: A potential home treatment for COVID-19 (https://covid19.nih.gov/news-and-stories/tempol-potential-home-treatment-covid-19). Trial to begin shortly.
SAN DIEGO, Aug. 24, 2021 — 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.
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