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Clinical Study Begins for the First Oral Systemic Nitric Oxide Based Therapeutic for African Americans with COVID-19

Microbiome Labs Taps CosmosID for Co-Development of BiomeFx Functional Gut Microbiome Test

The Medical Minute: The three types of COVID-19 tests

Is Spirituality a Component of Wisdom?

Study finds over 80 percent of COVID-19 patients have vitamin D deficiency

How the brain's immune system could be harnessed to improve memory

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Clinical Study Begins for the First Oral Systemic Nitric Oxide Based Therapeutic for African Americans with COVID-19

Nitric Oxide Innovations (NOI), LLC has received Investigational New Drug (IND #150758) clearance as part of the Coronavirus Treatment Acceleration Program (CTAP) from the U.S. FDA to begin a Phase 2b/3a outpatient clinical study testing the safety and efficacy of its new drug, NOviricid, 30 mg sodium nitrite dosing in an oral lozenge. NOviricid is the first oral Nitric Oxide (NO) generating drug to be clinically tested to treat African Americans diagnosed with COVID-19.  www.clinicaltrials.gov (NCT04601077)

NOviricid offers a fast acting, Nitric Oxide therapeutic, with proven vasodilatory and anti-viral properties, targeting the effects of the novel Coronavirus. NOviricid is a proactive treatment, to be administered at the early onset of symptoms to prevent the rapid progression of the virus, improve recovery and survival of African Americans or anyone who is symptomatic. NOviricid promises an easily administered, safe, affordable, and effective treatment.

MULTI-CENTER TRIAL

840 African American patients testing positive for COVID-19 within the previous 72 hours, will be selected for participation. Study participants must present with one or more comorbidities (high blood pressure, COPD, heart failure, diabetes, obesity, etc.) and will participate in a double-blinded, placebo-controlled study to determine the effectiveness of NOviricid. All study patients will be provided digital pulse oximeters and blood pressure monitoring equipment. These devices will be monitored remotely for changes in their oxygen levels. Primary endpoints are hospitalization, need for ventilation, and death.

To date, the COVID-19 pandemic has infected over 36 million people worldwide and is responsible for over 1 million deaths. In the U.S., African Americans are one of the most affected, high-risk populations. According to the Centers for Disease Control and Prevention (CDC), African Americans experience a 2.8x higher infection rate, a 4.7x higher hospitalization rate and 2.1x higher death rate than Caucasians. Those with comorbidities such as hypertension, diabetes, obesity, history of smoking, kidney disease and respiratory illnesses are most at risk for infection and rapid progression of the disease.

Dr. Nathan S. Bryan, Founder and CEO of NOI states, "Everything we have learned about COVID-19 over the past 10 months reveals that diminished nitric oxide production in patients is what is thought to be responsible for the increased risk of infection and rapid disease progression. This applies directly to the African American population, which often suffers from diminished nitric oxide production. A lack of nitric oxide explains the multi-system disease and dysfunction that persists long after the active infection is gone, including increased risk of blood clots, endotheliitis, kidney and lung dysfunction. Restoration of nitric oxide appears to be a very safe and effective solution."

In recent, and ongoing, studies using nitric oxide, it has been shown that nitric oxide inhibits Coronavirus replication. While inhaled nitric oxide has been used very successfully to treat critically ill patients on ventilators, it is expensive and difficult to deliver outside of the hospital setting making it impractical to treat patients recently diagnosed with COVID-19. By contrast, NOviricid, an orally disintegrating nitric oxide therapeutic, is administered before the patient is critically ill, ideally within 72 hours of a positive COVID-19 test. We believe that early intervention with NOviricid will prevent hospitalization, the need for ventilation and death. NOviricid is the first therapeutic in our long line of drug candidates."  

Bob Arnot M.D., NOI Chief Medical Officer, says: "Although severe COVID-19 infections can lead to Acute Respiratory Distress Syndrome (ARDS), its vascular effects should not be overlooked. COVID-19's effects on the vascular system affect the brain and heart and can lead to lethal effects on the blood clotting system. A key underlying mechanism of COVID-19 appears to be vascular endothelial dysfunction which explains the increased risk of infection and rapid progression of disease. This makes the restoration of nitric oxide a key strategy for the early treatment of COVID-19, especially in those with pre-existing conditions. Nitric oxide has been proven to be a potent vasodilator for small blood vessels, supplying healthy alveoli and potentially reducing the AV shunt seen in COVID-19 patients with severe ARDS on ventilators. NOI's IND clearance from the FDA allows us to quickly explore this promising therapeutic avenue.  This will be a game changer when it comes to COVID-19 therapeutics".

NOI's outpatient study will collect real time data via eCare21's telemedicine platform to identify disease progression in at-risk patients. Nitric oxide drug therapy will address all of the underlying risk factors for African Americans with COVID-19 and help protect them from the long-term complications, including risk of blood clots, embolism, heart attack and stroke. 

There are currently 4 clinical sites, enrolling up to 350 patients each, throughout the United States. Sites located in Chicago, IL; Houston, TX; Augusta, GA; and Jackson, MS will continue to enroll patients until the study reaches 840 participants.

Premier Urgent Care, located in the South Side Hyde Park area, is the clinical medical site representing Chicago, IL. Managing Partner and CEO, Michael A. McGee, M.D. states, "This is a very important study in helping to prevent hospitalization and death in high-risk African American patients with comorbidities. In fact, this is the first and only COVID-19 study specifically addressing the health disparities in people of color that seeks to prevent worsening short-term complications as well as long-term adverse effects."

Patient enrollment has already begun and will continue until all subjects have completed the study. If the trial proves the anticipated positive clinical outcomes, NOI will apply for a new drug application from the FDA at the end of the study. NOI is one of only 350 companies that have received review and clearance for an Investigational New Drug application as part of the CTAP.   

About Nitric Oxide Innovations, LLC:
Founded in 2018, Nitric Oxide Innovations was established to commercialize clinically and scientifically proven NO based technologies for a wide range of human diseases and conditions. NOI's mission is to be the industry leader and innovator of nitric oxide-based therapeutics, Nitriceuticals, and for the safe and effective treatments of a variety of human diseases.  Focusing on proven nitric oxide patented technology, along with patented innovative delivery systems, Nitric Oxide Innovations LLC will develop novel drug therapies ranging from topical drug deliveries to oral formulations for specific drug indications where safety and efficacy are already established. These new nitric oxide therapies will address pulmonary hypertension, non-obstructive but ischemic coronary artery disease (INOCA), heart failure with preserved ejection fraction (HFpEF) and chronic wound/ulcer therapy.  www.nitricoxideinnovations.com

Microbiome Labs Taps CosmosID for Co-Development of BiomeFx Functional Gut Microbiome Test

BiomeFx is an innovative and accurate gut microbiome test launched earlier this year by Microbiome Labs. The stool test is the result of a co-development partnership between CosmosID, Rockville-based provider of industry-leading bioinformatics software and laboratory services for microbiome R&D and infectious disease applications, and Microbiome Labs, the leaders in innovating microbiome solutions for healthcare practitioners.

Under the agreement, the CosmosID lab and software engineering teams have developed the platform for sequencing, analysis and reporting powering the BiomeFx test. With the current version of the BiomeFx report, clients gain access to an unprecedented amount of information on gut microbiome health. In addition to highly resolved information on gut microbiota composition, the test offers insight into microbiome function by revealing the metabolic potential of a client's gut microbiota. To better support urgent cases, a rapid-turnaround option is now commercially available.

BiomeFx is currently distributed to physicians, dietitians, and practitioners of functional medicine in the US and has reached several thousand customers since its early access launch in March.

"Most stool tests available today lack accuracy and reproducibility and ultimately fail to deliver actionable insights because they cannot reveal how the gut microbiome interacts with important health functions. Our ambition with BiomeFx was to drive the innovation necessary to overcome these widespread limitations," says Kiran Krishnan, Microbiologist and Chief Scientific Officer of Microbiome Labs. "Partnering with CosmosID, the industry leader in accurate microbiome analysis, was the obvious choice for this co-development partnership. CosmosID brings access to industry-leading and award-winning analytics and databases and operates a laboratory optimized for microbiome sequencing and infectious disease assay development."

"We see a growing demand for gut microbiome tests that are sufficiently accurate and functionally informative to enable healthcare professionals to deliver on the promise of personalized healthcare and nutrition. Conventional stool tests rely on methods that are either limited to only detecting a small part of the gut microbiome or that fail to identify gut microbes correctly and with species and subspecies level resolution," says Manoj Dadlani, CEO of CosmosID. "As a company specialized in supporting pre-clinical and clinical microbiome R&D with sequencing and bioinformatics for taxonomic and functional microbiome analysis, CosmosID is uniquely positioned to develop end-to-end microbiome testing platforms that are fast and cost efficient, yet highly accurate and reproducible." 

More information about the BiomeFx test is available at https://www.biomefx.com/. BiomeFx is not intended to be used as a diagnostic test but can be used in conjunction with other testing methods to provide a more complete picture.

Under the next phase of the co-development agreement, both companies plan to launch SARS-CoV-2 detection as an add-on feature of the BiomeFx stool test.

SOURCE CosmosID Inc.

The Medical Minute: The three types of COVID-19 tests

Eight months into the COVID-19 pandemic, questions about testing abound. With COVID-19 cases trending upward, it’s important to understand when individuals should seek getting tested and what type of test they should have.

Currently, there are three different types of tests to determine whether someone has COVID-19 or has previously been infected. The molecular test, also known as the PCR — short for polymerase chain reaction — is considered to be the most accurate in detecting viral particles. Although samples for the molecular test can be collected from saliva, a nasal swab inserted far back in the nostril — a procedure called a nasopharyngeal swab — remains the preferred way to collect samples.

“The sensitivity of the test is much better when you get that deeper specimen,” said Dr. Catharine Paules, an infectious diseases physician at Penn State Health Milton S. Hershey Medical Center. “Even though it's uncomfortable, that's the best way to get the test done.”

Another way to diagnose COVID-19 is with antigen testing, which identifies viral proteins in a sample, often obtained from a swab of the lower portion of the nostril or from the deeper, nasopharyngeal swab.

“These are more likely to be point-of-care tests performed on plastic card-based assays, similar to a pregnancy test where a line will show up if it’s positive for the virus,” said Dr. Melissa George, interim chair of the Department of Pathology at the Milton S. Hershey Medical Center. “But right now, only a few antigen tests have received FDA emergency use authorization, and they’re only available in small volumes.” This method is also not as sensitive as molecular tests.

A third type of test does not look for active infection, but rather for evidence — through antibodies present — that someone has had COVID-19 in the past.

Which tests are best?

If someone is concerned that they might have COVID-19, the best type of test is the nasal swab with the molecular testing, explained Paules. “That will show if you’re actively infected with the virus.”

Point-of-care molecular tests that take 15 to 30 minutes to be processed may be available at some physician offices. But because of their lower sensitivity and higher false negative rates, both Paules and George recommend tests that are processed in a laboratory. Physicians can provide patients with lab orders for the test.

Some organizations use molecular tests from saliva samples for surveillance testing efforts. These involve taking a random sample of a percentage of a particular population, such as a university’s student body, in an attempt to identify asymptomatic individuals who might have COVID-19 and could be infectious.

“If a positive individual is identified, contact tracing and appropriate follow-up can occur to potentially contain an outbreak,” George said.

The saliva is collected by spitting in a funnel test tube, usually while a medical provider is watching from a video link to make sure that enough sample is provided.

“As more data become available, saliva testing may start to be used more commonly in clinical — as opposed to just surveillance — situations,” George said.

Presently, the recommendations for when to use antibody tests are limited.

“We're mostly using them to help us define clinical syndromes that might occur after COVID-19,” Paules said. “For example, multisystem inflammatory syndrome. It’s a serious inflammatory complication of COVID in children. One of the ways that we’ve been able to discover that and diagnose patients with it is through an antibody test.”

As far as considering the results of an antibody test to be a clean bill of health from future COVID infections, Paules advised against that.

“There’s a lot we still need to learn about the virus,” Paules said. “We need to learn if infection protects against reinfection down the road. And if it does, are antibodies the way that we measure that protection? Even if I went and had a positive antibody test today, that would not inspire me to change any of my behaviors. I would still wear a mask. I would still social distance.”

Waiting while isolating

The turnaround time for test results varies depending on the condition of the person getting tested, George said. Hospitalized patients who are tested generally will get results the same day. For outpatients, the results may take up to several days. And because the need for surveillance testing results is not urgent, those results often take several days.  

If the demand for testing grows this fall and winter, the turnaround time for results may increase, regardless of the testing type, explained George.

While awaiting test results, it’s essential to continue to isolate.

“If you had some cold-like symptoms — you’re coughing, you have a fever — and you got a test, your next step should be to go home and keep to yourself until that test result comes back negative,” Paules said. “You don't want to infect anyone else while you're waiting for those results.”

Is Spirituality a Component of Wisdom?

Wisdom has gained increasing interest among researchers over the last few decades as a biologically based personality trait relevant to physical well-being and mental health. Previous studies have identified six common, measurable components of wisdom: pro-social behaviors (empathy, compassion, altruism and a sense of fairness), emotional regulation, self-reflection or insight, acceptance of divergent perspectives, decisiveness and social decision-making.

In a study published in the October 22, 2020 online edition of the Journal of Psychiatric Research, researchers at University of California San Diego School of Medicine add a seventh component of wisdom: spirituality.

“There has historically been controversy about whether spirituality is a marker of wisdom,” said Dilip V. Jeste, MD, co-first author of the study, senior associate dean for the Center of Healthy Aging and Distinguished Professor of Psychiatry and Neurosciences at UC San Diego School of Medicine. “Our findings show that spirituality is significantly associated with better mental health and well-being and may add to an individual’s overall wisdom.”

Data for the study was collected from a national sample of 1,786 adults ages 20 to 82 living in the United States. Participants completed the original 24-item San Diego Wisdom Scale, as well as other validated measures of spirituality/religiosity, well-being, resilience, happiness, depression, anxiety, loneliness and strength of social network.

“All of the components included in our self-report-based measure correlated with the overall wisdom score, but to varying degrees,” said Michael Thomas, PhD, co-first author of the study and assistant professor of psychology at Colorado State University. “The overall wisdom score had a much stronger association with pro-social behaviors than with spirituality. But still, spirituality was a significant indicator of wisdom.”

The researchers also found that spirituality correlated positively with age: older people tended to be more spiritual. And women scored higher in spirituality than men.

“Spirituality does not require religious faith but is characterized by humility and ever-present connectedness to oneself or to others or to an entity that is transcendent, such as Mother Nature or God or the soul,” said Jeste. “It helps reduce stress in many people and allows them to be more at peace, happier and healthier.”

“Feeling connected to something makes you feel less lonely. Loneliness and wisdom also have a strong connection in the opposite direction — that is, more wisdom would connote less loneliness.” 

A limitation of the study, the authors note, is that it was cross-sectional. “Longitudinal studies of more diverse samples are needed to explore mediation effects of these components on well-being and health,” said Thomas. “It is important to study whether interventions that target wisdom and its components improve overall well-being and quality of life. Having evidence-based measures of wisdom, including spirituality, can help us objectively test these ideas.”

Co-authors include: Jinyuan Liu, Rebecca Daly, Xin Tu, Emily Treichler, Barton Palmer, Ellen Lee, all at UC San Diego.

This work was supported, in part, by the National Institutes of Health (grants MH019934, R01MH094151-01, and K23MH119375-01), the Veterans Affairs Rehabilitation Research & Development (grant 5IK2RX003079-02) and the Stein Institute for Research on Aging at UC San Diego.

Study finds over 80 percent of COVID-19 patients have vitamin D deficiency

Over 80 percent of 200 COVID-19 patients in a hospital in Spain have vitamin D deficiency, according to a new study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism.

Vitamin D is a hormone the kidneys produce that controls blood calcium concentration and impacts the immune system. Vitamin D deficiency has been linked to a variety of health concerns, although research is still underway into why the hormone impacts other systems of the body. Many studies point to the beneficial effect of vitamin D on the immune system, especially regarding protection against infections.

“One approach is to identify and treat vitamin D deficiency, especially in high-risk individuals such as the elderly, patients with comorbidities, and nursing home residents, who are the main target population for the COVID-19,” said study co-author José L. Hernández, Ph.D., of the University of Cantabria in Santander, Spain. “Vitamin D treatment should be recommended in COVID-19 patients with low levels of vitamin D circulating in the blood since this approach might have beneficial effects in both the musculoskeletal and the immune system.”

The researchers found 80 percent of 216 COVID-19 patients at the Hospital Universitario Marqués de Valdecilla had vitamin D deficiency, and men had lower vitamin D levels than women. COVID-19 patients with lower vitamin D levels also had raised serum levels of inflammatory markers such as ferritin and D-dimer.

Other authors of the study include: Daniel Nan, José M. Olmos, Javier Crespo, and Víctor M. Martínez-Taboada of the University of Cantabria; Marta Fernandez-Ayala, Mayte García-Unzueta, Miguel A. Hernández-Hernández, Marcos López-Hoyos, Manuel Gutiérrez-Cuadra, and Juan J. Ruiz-Cubillán of the Hospital Marqués de Valdecilla-IDIVAL in Santander, Spain; Pedro Muñoz Cacho of the Servicio Cántabro de Salud in Santander, Spain. 

The manuscript received funding from Instituto de Salud Carlos III.