LONDON: The first UK clinical trials of a nasal spray proven to kill 99.9% of the coronavirus that causes Covid-19 will begin on January 11th at Ashford and St Peter’s Hospitals NHS Foundation Trust, in Surrey.
The SaNOtize Nitric Oxide Nasal Spray (NONS) is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs.
The treatment, developed by SaNOtize Research and Development Corp. based in Vancouver, Canada, proved 99.9% effective in killing the coronavirus in independent lab tests at Utah State University’s Antiviral Research Institute.
Additional studies in rodents with COVID-19 infection showed over 95% reduction within the first day after infection. It is currently undergoing Phase II clinical trials throughout Canada approved by Health Canada, and in other countries.
The SaNOtize treatment is based on nitric oxide, a natural nanomolecule produced by the human body with proven anti-microbial properties shown to have a direct effect on SARS-CoV-2, the virus that causes Covid-19. The treatment can be delivered by nasal spray, throat gargle or nasal lavage.
Lab tests on the SaNOtize treatment at Utah State University’s Antiviral Research Institute confirmed that the company’s Nitric Oxide Releasing Solution inactivated more than 99.9% of SARs-CoV-2, the virus that causes Covid-19, within two minutes.
Rodent studies performed at Colorado State University showed an average of over 95% reduction in SARS-CoV-2 viral load tested on the day following infection with half the rodents having no detectable virus at all. This was following inoculation with the virus and two treatments of SaNOtize’s nasal spray.
“Any intervention for treating coronavirus – the virus responsible for Covid-19 – is to be welcomed. The fact that a relatively easy and simple nasal spray could be an effective treatment is welcome news and offers a significant advance in our therapeutic armoury against this devastating disease. Ashford and St Peters Hospitals NHS Foundation Trust is proud to be at the forefront of trialling this intervention,” said Pankaj Sharma MD PhD FRCP, Professor of Neurology and Director of the Institute of Cardiovascular Research at Royal Holloway, University of London.
The importance of nitric oxide within the human body and its healing properties was first discovered by Prof Ferid Murad of Stanford University, among others, for which he shared the Nobel Prize in Medicine in 1998. Prof Murad is a member of the board of SaNOtize.
“Nitric oxide is an incredibly versatile molecule that regulates almost everything in our body,” Dr Murad said. “When used therapeutically, it has a well-documented safety profile and is demonstrated to be effective against a wide variety of viruses, bacteria and fungi. I’m excited to be working with the SaNOtize team and believe that they have a safe technology that could be effective in treating infections, including Covid-19.”
“The SaNOtize nasal spray provides a barrier. It contains nitric oxide which prevents and treats early infection by destroying the virus and impeding viral replication within the cells in the nose. In addition, nitric oxide has been shown to block the ACE-2 receptor essential for the virus to infect our cells. That is what makes our product unique and enables it to stand alone from any other nasal approach,” said Dr Chris Miller, chief science officer and co-founder of SaNOtize.
“It’s a safe technology that could be effective in treating infections, including Covid-19,” Dr Miller said. “Everybody just thinks you get the virus, and it gets into your lungs, and you die, but it’s a progression. First you get exposed to it, and the virus tries to attach to the cells in your nose, and it takes a while to incubate, and multiply in nasal cells for a few days and then the virus will shed into your lungs.”
“What we envision is cleansing the upper respiratory area at various points in the day. In the morning when you get up, where the virus has shed and started collecting in the back of your upper airway, first spray of the day, and then you go out into the day, and you can’t always control social distancing as we end lockdown, and so we have nasal sprays throughout the day. At the end of the day you come home and you basically rinse your nose and your nasopharynx, so that will clean your nose, your sinuses, and the back of your throat where these viruses initially reside,” Dr Miller said.
Rob Wilson, a former British government minister who represents SaNOtize in the UK and EU, is overseeing the trial.
“If, as we expect, the current Phase II results in Canada confirm the very encouraging results received from the Antiviral Research Institute and ongoing studies at Colorado State University SaNOtize will be seeking emergency approval in Canada to proceed directly to Phase IV introduction of the product to the market as part of the continuing global fight against this deadly pandemic,” said Wilson.
“The vaccination programme is essential, but it will also take time to distribute to the general public. Mutant strains may develop, requiring changes to the vaccine. It is not known how long the immunological protection will last.It is also unclear if the vaccines will prevent vaccinated people from becoming infected and potentially transmit the virus to other non-protected individuals.
For these reasons it is important to explore and deliver simple, safe and inexpensive therapeutic product solutions over the counter in the UK and EU as soon as possible, which is why I am getting these UK trials, the first in Europe, underway very shortly.
The nasal spray not only can block entry of the virus, but the active ingredient nitric oxide actually kills the virus and prevents it from multiplying. If successful, people in Britain and Europe could have an effective, safe and accessible treatment within months that they can use daily to kill the coronavirus and stop it spreading,” Wilson said.
“This simple treatment will assist us in resuming something approaching normal social life, work and travel with some confidence that even if we inhale the virus, we can both protect against it and destroy it by applying the SaNOtize solution on a regular basis,” Wilson said.
“The SaNOtize treatment should be thought of as an effective treatment for the upper airways, similar to when people use hand sanitizers to clean their hands on the outside of the body. When people are potentially exposed, they will spray to cleanse their upper airways and kill the virus, before it can cause serious illness,” Wilson said.
Research published in Nature confirms that the nose is the primary infection area especially in the early period of the infection. Hospital trials with nitric oxide are underway in the US and Europe with seriously ill coronavirus patients inhaling the gas to kill the virus in their lungs and prevent progression to severe infection. SaNOtize’s solution can be applied away from a hospital setting. It is easy to use, inexpensive and safe.
The company’s strategy is to use the Nitric Oxide spray as a multi-stage defence against infection and to provide an effective treatment for mild and moderate cases with the goal of preventing severe inflammatory response and infection of the lungs.
Scientists believe the coronavirus is transmitted via airborne droplets to the mucous membranes in the nose, where it is replicated during a three-day incubation period, damaging the nasal mucosa cells, and is then carried in nasal secretions to the lower respiratory tract, leading to the danger of fatal viral pneumonia.
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