Benzinga | Aug 24, 2021 07:31AM EDT

Adamis Pharmaceuticals Highlights Publication With The Human Immune Monitoring Center At Stanford Demonstrating Tempol 'Significantly Inhibited Multiple Cytokines from COVID-19 Patient's Cells'

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&#x2A;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.