Need a follow up on this from the company.
Adamis Pharmaceuticals Announces License to Commercialize Tempol, a Novel Investigational Anti-inflammatory and Antioxidant Drug for the Treatment of Respiratory Diseases Including COVID-19
SAN DIEGO, June 15, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today a license to commercialize Tempol, a novel patented investigational drug for the treatment of Coronavirus (COVID-19). The license includes the worldwide use of Tempol for the treatment of all respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19. In addition, the exclusive license includes the use of Tempol for reducing radiation dermatitis in patients undergoing treatment for cancer. A phase 2 radiation dermatitis clinical study has already been successfully completed, as well as discussions with FDA regarding the design of a pivotal phase 3 study. The license was obtained from Matrix Biomed.
In consideration for Matrix providing the exclusive rights under its patent rights and related know-how relating to Tempol within the licensed fields, Adamis paid Matrix $250,000 following signing of the definitive agreement. Adamis will also issue to Matrix 1,000,000 shares of Adamis convertible preferred stock, which will be convertible into an equal number of shares of common stock after and contingent on an increase in the number of available authorized shares of common stock under the company’s restated certificate of incorporation. Under the agreement, if any products are commercialized, net profits will be equally distributed between the parties.
Coronavirus disease [Novel Coronavirus Disease (COVID-19), a human betacoronavirus] represents a global health problem. Just within the U.S., the American Hospital Association estimates that the financial impact in losses for America’s hospital and health care systems could exceed 200 billion dollars by mid-2020. Therefore, identification of new drugs and biologics for treating COVID-19 infection is urgently needed. Most common symptoms at onset include fever, cough, sore throat, sneezing, rhinorrhoea (runny nose) and fatigue. In severe cases, this can progress to pneumonia, acute respiratory distress syndrome (ARDS), acute cardiac injury and eventually death. ARDS occurs when there is damage to the lungs resulting in fluid accumulation in the small air sacs of the lungs. This fluid causes a decrease in the oxygen supply to vital organs which can eventually lead to death.
Tempol has demonstrated anti-inflammatory, anticogulant, and antioxidant activity. Tempol specifically targets ARDS, which is the major cause of death of COVID-19. Both inflammatory cytokines and reactive oxygent species (ROS) generated from cells of the immune system (macrophages and neutrophils) damage the lungs in ARDS patients. In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm) such as TNF-a, IL-Iß, IL-6, IL-10, NF-kß, ICAM-1, HIF-1a, HIF-2a and others. In addition, Tempol works as an antioxidant and decreases the harmful effects of ROS. ROS is a type of unstable molecule that contains oxygen and easily reacts with other molecules in the cell. It can cause damage to all macromolecules, i.e., lipids, DNA, RNA and proteins. In addition, Tempol has also been shown to decrease platelet aggregation and clotting, a problem observed in many COVID-19 patients. Published articles describing animal models of ARDS show Tempol to cause a decrease in lung inflammation and preserve lung pathology associated with acute and chronic lung injury. Additional published studies, in which animals were infected with betacoronavirus, show that Tempol treatment resulted in increased survival and decreased viral load. Taken together, this scientific data argue for the use of Tempol in preventing and treating the most severe death related lung manifestation of COVID-19. Tempol has already been shown to be safe in multiple human clinical studies.
Dr. Dennis J. Carlo, President and CEO of Adamis commented: “We are hopeful that Tempol can be part of the solution to the current pandemic. We believe that Tempol’s multiple modes of action such as an antioxidant, an anticoagulant, and an anti-inflammatory may be more beneficial than targeting a single pathological pathway. Tempol has been the focus of numerous peer reviewed published articles by highly respected scientists from various institutions such as: Radiation Biology Branch of the National Cancer Institute, National Institute of Health, FDA Center for Drug Evaluation and Research, Georgetown University, University of Pittsburgh, University of Pennsylvania, Weizmann Institute, Johns Hopkins University, University of California San Diego, University of Texas and many more. Tempol has been shown to be involved in cellular metabolism, apoptosis, (form of programmed cell death or cellular suicide), cell growth and development, stress response, inflammation, and angiogenesis. Its role in decreasing multiple pro-inflammatory cytokines and controlling both the overactive inflammatory response and the cytokine storm could lead to one treatment strategy that helps decrease the burden to our health care system by reducing hospitalizations and potentially saving the many lives of those infected with COVID-19.”
Dr. Ronald Moss, Chief Medical Office at Adamis, stated “The previously published studies of Tempol provide a reasonable scientific rationale to begin immediate clinical testing against COVID-19 during this pandemic. We plan on leveraging our depth of clinical experience with respiratory viruses and government collaborations to focus on this urgent public health problem. To this end, Adamis will apply for government and other forms of funding to conduct well designed clinical trials and will work closely with FDA to expedite the testing. Our goal is to test Tempol against COVID-19 as soon as possible. Clinical trial material is currently available, since Tempol is an investigational drug currently in human trials for other indications.”
