Corona up your NOse

Humanity is saved, the COVID-19 pandemic will be over soon, thanks to NO other but nitric oxide (NO). The no-nonsense NONS nasal spray is marketed by the Canadian startup SaNOtize, contains a nitric oxide-releasing solution and is meant to work as upper airway “disinfectant”. It is declared to be 99% effective against a SARS-CoV2 infection as therapy and 100% effective as preventive in clinical trials in Canada and UK. The Nobelist Ferid Murad is board member of SaNOtize which was founded by an Israeli scientist and has a former UK government minister as press speaker.

The company’s previous incarnation was Bovicor, which used to offer NO spray to cattle, against bacterial infections, and ceased to exist around 2017. Maybe Bovicor’s research publications failed to convince investors and authorities, in any case its successor SaNOtize does not publish any research, neither in peer reviewed journals nor as preprints, at least so far. SaNOtize communicates its clinical breakthroughs on chronic sinusitis, diabetic foot ulcer, nail fungus, and now of course COVID-19 exclusively via press releases. Which, according to media, is perfectly convincing. SaNOtize also announced to have already received approval to sell NONS in Israel and New Zealand, which was duly reported by Reuters and proved to be, shall we say, somewhat incorrect.

The company’s founder and Israeli Scientist Gilly Regev told excited Israeli media:

“If you use it daily, I really believe you won’t be affected by Covid-19. We have shown in the clinical trials that the people who used it did not get infected.“

It seems however, YouTube deleted the related promotional video, only a screenshot remains:

The hype, which made news not just in Israel or Canada but worldwide, in particular in the pandemic disaster area India, started with a press release from 15 March 2021:

UK Clinical Trial Confirms SaNOtize’s Breakthrough Treatment for COVID-19

“In a randomized, double-blind, placebo-controlled 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. The average viral log reduction in the first 24 hours was 1.362, which corresponds to a decline of about 95%. 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. There were no adverse health events recorded in the UK trial, or in over 7,000 self-administered treatments given in earlier Canadian clinical trials.”

Before we dive in, meet the key characters of the SaNOtize team.

1. Gilly Regev, Chief Executive Officer & Co-Founder, previously Chief Scientific Officer and co-founder of Bovicor, with a PhD from the Hebrew University in Israel.
2. Chris Miller, Chief Science Officer & Co-Founder, previously co-founder and CEO of Bovicor and “Retired Assistant Professor” at University of British Columbia (UBC) in Vancouver, Canada (his now deleted lab here).
3. Rob Wilson, press speaker for UK and former Tory politician who was lost his Parliament in 2017 and now reminds everyone that he used to be government minister (for Civil Society, and only very briefly because an interim replacement was urgently needed).
4. Ferid Murad, board of directors member and winner of the Nobel Prize in Physiology or Medicine in 1998, for discovery of NO as messenger molecule, which he shared with Robert Furchgott and Louis Ignarro. Murad joined the SaNOtize board in February 2020.

My regular readers know and cherish Louis Ignarro as an unashamed shill for Herbalife and POM Wonderful, who also co-authored a long string of papers with falsified data (read here). Why Ignarro is not also a remunerated board member of SaNOtize is beyond my understanding, or maybe it is actually all my fault?

Die with a stiffy?

By the way, Murad has also published falsified science (one retraction for data manipulations which he insisted “do not affect the scientific conclusions“) and neither is Murad averse to supplement shilling. Soon after getting his Nobel, he went into the “health and wellness” industry where he first worked with the same David Brubaker who recruited Ignarro to push Herbalife supplements. Murad started by pushing Brubaker’s own Lenier Health Products supplements. Until the Nobel shill found an even more rewarding cash source: Forever Living, a supplement company whose products Murad has been eagerly advertising, promising, I kid you not, sex with younger women. Here his original quote, endorsing the arginine supplement “Argi+” which is supposed to serve as source of nitric oxide:

“Not only can this little miracle molecule help you to get healthy, fit, and in shape fast, but it can also help you to look younger and offer a better sex life “

That is because nitric oxide is involved in dilating blood vessels and thus in helping you, dear ageing male reader, raise an erection, so there. Even if SaNOtize’s NO spray therapy wouldn’t so reliably prevent COVID-19, you would still die with an admirable boner, leaving a beautiful corpse. Thank Professor Murad for this!

Even if his fellow Nobel shill Ignarro was inexplicably not available to join the board of SaNOtize, Murad certainly was. Maybe he was just cheaper. The Nobelist (who did not react to my emails) was quoted in a SaNOtize press release from a year ago:

“Nitric oxide is an incredibly versatile molecule that regulates almost everything in our body.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.“

And before we move on, here is Murad at a bizarre “FLOGEN” scamference organised by Florian Kongoli. You never heard of Kongoli’s events, which appear to be the cheapest predatory circus in the style of Ashutosh Tiwari, but with a ridiculously unconvincing website presentation? The best of the best in science take part there, for reasons beyond any attempts to fathom (read Pepijn van Erp‘s reporting): the unhinged quack and antisemite Ruggiero Santilli, the EU-grant-pilferers father and daughter Aifantis, and indeed several Nobelists like Murad, Fraser Stoddart or Andre Geim.

So now let’s talk about the NORS science which received the Nobel blessing.

The cow goes moo

This is apparently how the COVID-19 crusher miracle treatment NORS began: as NO therapy for humans and cows, first marketed by Miller’s Nitric Solutions Inc, which then was succeeded by Bovicor and now by SaNOtize. Regev was always part of the team. From a 2014 press release by UBC:

“Dr. Miller has been researching NO since 1990 and wrote the first review article of NO in 1992. Through their company Bovicor Pharmatech Inc., Dr. Miller and the team have developed the first NO-nitrosylite as an intranasal NO-releasing spray called BovinexTM that can be administered in a few seconds to beef cattle during processing at the feedlot. 

Dr. Miller has been researching NO since 1990 and wrote the first review article of NO in 1992. Through their company Bovicor Pharmatech Inc., Dr. Miller and the team have developed the first NO-nitrosylite as an intranasal NO-releasing spray called BovinexTM that can be administered in a few seconds to beef cattle during processing at the feedlot. ”

I wrote to SaNOtize, asking for their research publications regarding the nitric oxide therapy for COVID-19 as well as previous applications. The CEO Regev sent me this “reading list”:

As you see, there is nothing on any coronaviruses at all. All papers (except one about flu virus in cell culture, Regev et al 2013) are about bacterial infections in cattle, to promote the NO products of Regev’s and Miller’s former company Bovicor. That is very unfortunate, because already in 2014 the UBC assistant professor Miller declared to be funded by the Pentagon to save the world from pandemics like this one:

“I am focused on establishing a Nitric Oxide Research Program at the University of British Columbia’s Department of Medicine, with the goal of developing NO as a potential treatment for infections such as tuberculosis, malaria, leishmaniasis, cystic fibrosis, and as a first line treatment for viral pandemics. The cornerstone of this effort has been generously provided through a highly sought after, but rarely obtained, United States Defense Advanced Research Projects Agency (DARPA) Grant for my project entitled, “Nitric Oxide for Prevention and Treatment of Pandemic Flu.”

By the way, next to Bovicor (which website ceased to exist before the most recent paper was published), also Regev listed as her affiliation “Faculty of Medicine, Respiratory Division” at UBC. Yet to me, Regev denied ever have worked as postdoc in Miller’s lab. So why the affiliation then?

Revolution per press release

Ok, there is no preclinical research on coronaviruses, and just one in vitro paper about the flu virus. Who cares, it worked in clinical trials! Look, from same recent press release:

“I expect this to be a major advance in the global battle against the devastating human impacts of the COVID-19 pandemic,” said Dr. Stephen Winchester, Consultant Medical Virologist and Chief Investigator of this NHS Clinical Trial. “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.”

I wrote to Stephen Winchester and his Ashford Hospital in London, asking about the trial registration, because there is nothing on clinicaltrials.gov. I only found the UK ethics approval from November 2020. Which is even more strange because Winchester is not generally averse to registering his commercial COVID-19 research there, here a trial he did in 2020 for another company. The Ashford Hospital announced in December 2020 to publish the SaNOtize trial’s detail on their own site, but then chose not to.

Neither Winchester not his hospital replied initially, but a reader found a registration on the EU trial site. That one is strange. Here are key differences to the press release:

1. 50 trial participants registered instead of 79 COVID-19 patients in the press release.
2. Sponsor registered “Ashford and St Peter’s Hospitals NHS Foundation Trust“, “non-commercial”, while it is perfectly clear that SaNOtize sponsored the trial
3. According to trial registration, comparisons “between NONS and control” were supposed to be made at “Day 2, 4, 6, 9 and 18“. The press release touts 95-99% virus reduction only for day 1 and 3 instead.

Mind you, the investigators measured RT-PCR data in patients with mild COVID-19 to claim a 99% efficiency, without hinting at details. How they arrived at 99% efficiency is a mystery you are not supposed to be privy to. Winchester eventually replied to explain at least some of irregularities:

“An amendment was approved to enrol more than 50 patients. The study is in the process of being published and I will let you know of the preprint as soon as possible“

First of all, the whole point of trial registration is to allow oversight of what the investigators changed. How many participants did Winchester treat at the end? 50? 79? 100? 179? Any number is possible, you just have to trust that no patients were removed from the analysis for failing to get cured by NONS. Also, while Winchester promises a preprint, Regev hinted to me that they apparently want to wait for their study to pass peer review:

“The independent group who ran the trial in the UK has submitted the manuscript for publication. I will inform you when it is accepted.“

Never mind, who needs the data. Wilson, the former politician turned UK trial overseer, was quoted recently:

“We have, on the back of that trial, applied for emergency approval both in the UK and Canada. We believe that it will also be used as preventative medicine“

A hundred nose shots

You may recall that the press release also mentioned a clinical trial in Canada, with no less than “7,000 self-administered treatments“:

“In addition to providing antiviral treatment in the early stages of infection and for those who have yet to be vaccinated, NONS has also demonstrated that it could also reduce infectivity – the frequency of transmission from an infected person to a non-infected person.

The results of the UK trial corroborate the information gathered from SaNOtize’s earlier Phase 2 trials in Canada and independent lab tests at Utah State University’s Antiviral Research Institute.”

SEVEN THOUSANDS patients, wow. Not so fast. The “randomized, controlled” trial NCT04337918 only had 143 participants. And there was no placebo control whatsoever. The control arm was namely “No intervention: Standard Precautions” only. So the 7000 treatments refer to 100 spray shots up 70 noses. No results were published, maybe because nobody caught COVID-19 in that trial, neither in the NONS arm nor in the placebo-free control. Which somehow proves that NO spray is 100% effective in preventing coronavirus infection, right?

Also, the “99.9% effective in killing the coronavirus” results from the Utah State University’s Antiviral Research Institute (which offers “fee-for-service testing for private pharmaceutical and research companies”) are not published anywhere. The only existing source, paraded for example by Winchester’s Ashford Hospital, is an old SaNOtize press release. The hospital also claimed Rob Wilson was “overseeing the trial“, due to his qualification as “former British government minister“. Elsewhere, in Israeli media, we learn of

“Separate animal studies with rodents performed at Colorado State University showed an average of over 95 percent reduction in SARS-CoV-2 viral load tested on the day following infection with half the rodents having no detectable virus at all.“

Also these studies are not published anywhere, probably for a good reason, if you get my drift. But then again, we scientifically illiterate rubes are not supposed to know the details of those preclinical research and clinical trials, because, look the national authorities already approved NONS spray for sale! Another SaNOtize press release, from 22 March 2021 yet not listed on company’s website:

Israel and New Zealand Permit Sale of SaNOtize’s Breakthrough Anti-Viral Nasal Spray

“Manufacturing of NONS, under the brand name Enovid^™, has begun in Israel with SaNOtize’s manufacturing partner Ness Ziona-based Nextar Chempharma Solutions Ltd. Enovid is expected to appear on pharmacy shelves in Israel by the summer.

In New Zealand, SaNOtize has registered its nasal spray with the New Zealand Medicines and Medical Devices Safety Authority, which permits the company to distribute and sell NONS over the counter immediately.

“The product we have developed, which kills viruses in the upper nasal pathways, will be delivered via a nasal spray bottle that contains a month’s supply for an individual,” said Dr. Gilly Regev, the Israeli CEO and co-founder of SaNOtize. “We look forward to updating the public in Israel and New Zealand with details on when Enovid will hit store shelves.”

That was duly reported by Reuters and other news outlets. Only that it was not exactly true, the New Zealand government had to reject false claims by SaNOtize:

“The ministry said the “approval referred to in information about the product may be related to a notification made to the New Zealand Web-Assisted Notification Database (WAND) operated by Medsafe… where medical devices for supply in New Zealand are required to be notified.  

“This requires self-notification by companies wishing to supply medical devices and is not an application or approval process. The presence of an entry on this database does not confirm or imply that the product meets the requirements of the Medicines Act 1981.”

Reuters later updated its version of the story, but the original report remains on many news sites. The Ministry of Health said it would remove Enovid from the WAND database, and would let SaNOtize know it can’t be sold here until it gets approval.“

Bad journalists!

Regev wrote to me blaming the journalists for not reading her press release properly:

“We never lied. We put a press release stating that the spray was approved in Israel (which it is, by the MOH), and that it was registered in New Zealand, which it was. The media have changed the language to “approved in NZ” which caused the confusion.“

What if that the same “misunderstanding” happened in her own Israel? Regev did not reply to my question in this regard. Thing is, the Ministry of Health (MOH) didn’t even approve the other miracle cure by another Israeli Scientist, EXO-CD24, which the Prime Minister Netanyahu himself has been touting, and that one was also supposed to work as nasal spray! (read here). In any case, neither Regev’s nor Nadir Arber’s nasal sprays are so far unavailable even in Israel, or anywhere else on this planet. An auto-reply email from SaNOtize I received this week stated:

“For nasal spray availability, please note this product is not available for purchase yet. Upon approval by the health authorities in your country, we will update our website accordingly. Unfortunately, we cannot give you any specific timelines, nor any more detailed information at the moment.”

Not even in Israel. In March 2021, Miller and his SaNOtize was apparently also misquoted by journalist who wrote:

“The company and various governments are in talks to decide if the spray will need a prescription or will be available over the counter.”

Let’s pray nations won’t got to war over who gets NONS first! There will be hopefully enough of it, Israeli media reported last month:

“Regev said that the factory, in Ness Ziona near Tel Aviv, is working to produce a stock of 200,000 to 500,000 bottles by May. “After this we’re hoping to get to capacity of a million bottles a month,” the Hebrew University graduate said, adding: “I hope this product will bring pride and jobs to Israel.”

I’m sure it will. The competition in the Israeli Scientists comedy contest is tough during this pandemic, but Regev has an actual Nobelist on board, don’t forget that.

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