These results are also consistent with the results that the Company announced regarding in-vitro cytokine data from
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.
In addition to
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.
Senior Director, Investor Relations
& Corporate Communications
Source: Adamis Pharmaceuticals Corporation