Community Weekly Report 5

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Volume 2, Edition 5

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Inspire, Inform & Educate

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February 4 - February 10, 2021

Page 3

FDA Approved COVID-19 Clinical Trial Makes History Dr. Richard E. Harris II, M.D., Pharm.D., MBA

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Addressing

Health Disparities

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alarming releases by The Centers for Disease Control and Prevention (CDC) continue to report the racial and ethnic disparities in illness and death in COVID-19. It is widely known that underlying medical conditions increasing this risk for severe illness from COVID-19 may be more common among people from racial and ethnic minority groups.

And the common underlying conditions among those who require mechanical ventilation or died included diabetes, high blood pressure, obesity, chronic kidney disease on dialysis, and congestive heart failure. But through a new FDA-approved clinical trial, this first of its kind study is specific in developing a cure to help African Americans with the coronavirus. Nitric Oxide Innovations (NOi), founded and led by Dr. Nathan S. Bryan, established this study to prevent the rapid progression of the virus, improve recovery and survival of African Americans, or anyone who is symptomatic.

Among the adept and renowned medical team supporting Dr. Bryan’s study is Dr. Richard E Harris II. Not only as a doctor, but as an African American seeing how the coronavirus impacts our community, Dr. Harris recognizes this clinical trial’s focus is imperative for a cure to help combat the disease, reducing the number of infections among African Americans.

NOi is positioned to advance patented nitric oxide (NO) science into new and innovative therapies for human disease across different markets. NO is considered one of the most important molecules naturally produced by the human body. Loss of NO is one of the most important contributors to aging and age-related disease.

It is a cell-signaling molecule responsible for many important and essential cellular functions including acting as a vasodilator and regulating oxygen delivery.

Our endothelial cells, the cells that line the interior surface of our blood vessels, are the main source of NO production. Endothelial NO production is what maintains the integrity of our endothelium. Loss of NO is referred to as endothelial dysfunction. Every major chronic disease is characterized by endothelial dysfunction.

NO is also important in our immune system. NO produced by macrophages and neutrophils is responsible for killing invading pathogens such as bacteria and viruses.

NO is vital for the maintenance and regulation of blood flow. It’s also important for our immune system. “The older you get, the less nitric oxide you make, and once you hit 40, NO levels start to rapidly decrease. But also certain diseases, like cardiovascular disease and diabetes, are known to decrease NO, as well as lack of exercise and certain dietary decisions. So if you’re eating a lot of processed foods or not enough fruits and vegetables, you can decrease NO. And we also know that there are some genetic abnormalities and genetic differences that African Americans have that contribute to lower NO levels,” said Dr. Harris. This contributes to the reasoning as to why we are seeing the health disparities with COVID-19, where the African-American population is being hit at a much higher rate with the disease. “NOi’s clinical trial is targeting African Americans in the 50 to 85 age range with pre-existing conditions. This is the highest risk group and the group that we’re most likely to see in the hospital, being most at risk for severe COVID infection and the worst outcomes. So this is the group that we really want to focus on keeping out of the hospital, because once they are admitted to the hospital,

This clinical trial is being done to help provide a solution and answers to help address the health disparities that we see, with safe and effective therapy. Unless we do the research and unless people are willing to come forward, we cannot develop a solution. And if we don’t address the health disparities, they’ll continue to grow over time. The participants in this study are going to advance science.”

—Dr. Richard Harris M.D., Pharm.D, MBA

the stays for this group are very long, and the risk of severe complications is very high. We’re still scratching the surface on the long-term implications of COVID,” Dr. Harris said Dr. Bryan has earned the support of Dr. Harris and the medical community in this study as he is a global leader in molecular medicine and nitric oxide biochemistry. “We recognized early on that our patented NO technology would have a very important role in the treatment and protection from the coronavirus. We filed for our investigational new drug application (IND) through the Food and Drug Administration (FDA) as part of the Coronavirus Treatment Acceleration Program back in June 2020 and received clearance in July. The FDA immediately recognized how our study design and technology could potentially impact the African American community, allowing us to move forward with our study,” said Dr. Bryan.

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