A clinical trial in United Kingdom confirms SaNOtize’s breakthrough treatment for COVID-19
SaNOtize R. & D. Corp, a Canadian Biotech Firm has recently announced their results of clinical trials indicating that the Company’s Nitric-Oxide releasing Nasal Spray (NONS) appears a safe and effective antiviral treatment against coronavirus. This nasal spray can prevent the transmission of COVID-19, furthermore it reduces the severity of symptoms and damage, shortens its course in patients already infected by SARS-CoV-2. In a randomized, placebo-controlled, double-blind, Phase 2 trial that evaluated 79 confirmed cases of COVID-19, SaNOtize’s early treatment for COVID-19 significantly reduced the level of SARS-CoV-2, including in patients with high viral loads. In the first 24 hours an about 95% decline was found, within 72 hours, the viral load dropped by more than 99%. The majority of these patients had been infected with the UK variant, which is considered a variant of concern. Trial concluded that treatment accelerated clearance of SARS-CoV-2 by a factor of 16-fold versus a placebo. There were no adverse health events recorded in the clinical trial, or in over 7,000 self-administered treatments given in earlier Canadian clinical trials. Nitric-oxide nasal spray is the only novel, easy-to-use therapeutic treatment so far proven to reduce the viral load in humans that is not a monoclonal antibody treatment. Monoclonal antibodies are highly specific, expensive and must be administered intravenously in a clinical setting under close medical inspection. Submission for Emergency Use in the UK and Canada for the treatment and prevention of COVID-19 by Niric oxide nasal spray is planned immediately.
Dr. Stephen Winchester, Consultant Medical Virologist and Chief Investigator of the above mentioned NHS Clinical Trial said:”I expect this to be a major advance in the global battle against the devastating human impacts of the COVID-19 pandemic.” This simple portable nasal spray could be highly effective in the treatment of COVID-19 and reducing onward transmission. Our trial included patients with a variant of concern and high viral loads yet still demonstrated significant reductions in the levels of SARS-CoV-2, which could be critical in supporting vaccines, preventing future outbreaks and safely reopening economies. Simply stated, I think this could be revolutionary.”
The SaNOtize treatment is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. It is based on nitric oxide (NO.), a natural free radical molecule 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 pharmacology, toxicity, and safety data for NO use in humans has been well-established for decades. The NO molecule released from NONS is identical to the one delivered in its gaseous form to treat persistent pulmonary hypertension, or Blue Baby Syndrome, in newborn babies.
Cyclodextrins and Nitric-oxide:
The interaction of NO and NO-releasing pro-drugs with cyclodextrins has long been known and over 100 relevant papers can be found dealing with cyclodextrin-assisted NO-release.
In 1994 Vikmon, M. et al reported on different cyclodextrin-stabilized NO-releasing agents suitable for pharmacological uses. (Vikmon; Szeman, J.; Szejtli, J. PREPARATION AND PROPERTIES OF A PHYSIOLOGICALLY ACTIVE NITROGEN OXIDE RELEASING AGENT 7th Int. Symp. on Cyclodextrins, Tokyo, 25-28 April, pp 405-409, 1994.)
A NO-releasing pharmaceutical formulation based on cyclodextrin was disclosed in a patent. (Geczy, J.; Vikmon, A.; Szejtli, J. Szente, L.; Szeman, J. Preparation of stable, nitric oxide-releasing N-morpholino-N- nitrosaminoacetonitrile-cyclodextrin inclusion complexes WO 9529172 A1 951102. 1995.)
Even S-nitrosated cyclodextrin monomers and polymers as efficient NO- releasing agents were studied and patented. (Stamler et al US Patent 5,770,645, 1998. POLYMERS FOR DELIVERING NITRIC Oxide) J.Stamler E. Toone R.Stack Novel polymers for delivering nitric oxide in vivo US Patent 2003/0078365A1 US20030078365A1
(Haibao Jin, Lei Yang, Mona Jasmine R. Ahonen, and Mark H. Schoenfisch* Nitric Oxide-Releasing Cyclodextrins J Am Chem Soc. 2018 Oct 31; 140 (43): 14178–14184.)