Name: Ann Arbor company says its nasal antiseptic can kill coronavirus
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Ann Arbor company says its nasal antiseptic can kill coronavirus

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Detroit Free Press With the blessing of British scientists, a Michigan bio-pharmaceutical company is hitting the market with an over-the-counter nasal antiseptic that it says has killed COVID-19 in lab tests.Neither the Center for Disease Control nor the FDA have conducted trials to know whether the antiseptic can actually kill COVID-19. And the makers stress: "It's not a cure."But scientists at BlueWillow Biologics in Ann Arbor believe they are onto something.&nbsp;This month, the company announced that laboratory studies by Public Health England show that their antiseptic has the ability to kill COVID-19 in lab tests.&nbsp;The product is called NanoBio Protect, an alcohol-free, fragrance-free antiseptic that you swab the inside of your nose with.&nbsp;The makers are promoting the product as an added form of protection against the virus, to be used in conjunction with frequent hand washing, limited touching of the face and social distancing."We see it as part of a total program to prevent infection. It's not a cure," said Dr. Chad Costley, chief medical officer at BlueWillow, stressing: "It's part of a total solution to help people get back to their lives."BlueWillow, a spinoff from the University of Michigan that develops topical antiseptics and intranasal vaccines, is donating 40,000 bottles of its new antiseptic to health care workers across the country. It is currently selling the product&nbsp;on its website for $24.95 a bottle, with plans to soon go live on Amazon and be in drugstores by summer. A bottle&nbsp;lasts about a month,The active ingredient in NanoBio Protect is benzalkonium chloride, a compound that has been approved for over-the-counter sales by the FDA and has been used in humans since the 1940’s. It is found in many consumer products — such as skin antiseptics, wound wash sprays, cold sore treatments, hand sanitizers and as a preservative in eye, ear and nasal drops.&nbsp;According to the manufacturer, NanoBio Protect is similar in concept to a hand sanitizer, but is designed for use on the skin inside and around the nose where germs frequently enter the body and can be applied with a standard cotton swab.BlueWillow developed the antiseptic using its patented nanotechnology, which uses oil-in-water nano-droplets for products applied to the skin and nose. The droplets are small enough to be applied to the skin, the company says, but too large to get into the bloodstream."It's approved for use by the FDA as a treatment to kill germs on the skin," Dr. Costley said of the company’s nanotechnology. "As long as we stay within the FDA guidelines, we're approved for uses in the United States."Neither the CDC nor the FDA have weighed in on the product, though the CDC has held that benzalkonium chloride&nbsp;— the active ingredient in the antiseptic&nbsp;— is not adequate to kill COVID-19. In its guidance on which hand sanitizers are effective for health care workers treating COVID-19 patients, the CDC said this:"Benzalkonium chloride, along with both ethanol and isopropanol, is deemed eligible by FDA for use in the formulation of healthcare personnel hand rubs," the CDC website states. "However, available evidence indicates benzalkonium chloride has less reliable activity against coronavirus than either of the alcohols."The CDC has recommended using alcohol-based hand rub or hand-washing with soap and water to prevent the spread of COVID-19 and infections, and says sanitizers containing 80% ethanol or 75% isopropanol can deactivate the virus.Meanwhile, the FDA is issuing warning letters to firms across the country for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19. BlueWillow is not one of them.Related:&nbsp;Related:When the COVID-19 outbreak began to spread, BlueWillow, which for years has worked on developing anti-viral and anti-bacterial skin products, was eager to find out if its nanotechnology would work against the coronavirus.So it reached out to its international partner, Public Health England, the research branch of Great Britain’s health department. The Michigan company and British health agency were already working together with the National Institutes of Health to develop an intranasal anthrax vaccine, which is currently being tested."We have an existing relationship with Public Health England ... we naturally reached out to them first. They know us. They believe in us," said BlueWillow CEO Dave Peralta, adding: "NIH is certainly behind the relationship."According to BlueWillow, here is how Public Health England tested its product, and what was found:British researchers mixed the virus with the NanoBio Protect. Samples were taken after five, 20, and 30 minutes and plated for viral counts. After five to seven days, the plates were fixed and stained, and the plaques were counted. The results were conclusive: the antiseptic killed the COVID-19 virus at every time point.&nbsp;"We have concluded that all NEs (droplets) tested are effective at deactivating virus by at least 5 logs (99.99%)," Public Health England told BlueWillow&nbsp;in documents reviewed by the Free Press."Our ongoing partnership with PHE enabled us to move quickly and confirm that NanoBio® Protect is effective in killing COVID-19 in vitro, which is consistent with what we have observed with every bacteria and enveloped virus we've tested to date," Peralta said. "These results are encouraging and suggest that this product may be an important additive measure to hand washing and social distancing.”Dr. Daniel Rontal, an ear, nose and throat specialist for Beaumont Health, said he is skeptical about&nbsp;BlueWillow’s new nasal antiseptic for several reasons: There’s been no human testing for it. The active ingredient in the product, benzalkonium chloride, is currently listed as not adequate by the CDC to kill COVID-19. And other data suggests this same compound “is not good for the nose,” he said.“At this point, it’s not something that I would want to be using in my nose,” Rontal said. “It has not been shown and cleared by the CDC and FDA in adequate trials to know that it can actually kill COVID-19. And there’s evidence that it may be bad for the nose.”According to Rontal, multiple studies have shown that benzalkonium chloride can interfere with the nose’s ability to flush and clean out mucous that builds up, which can lead to more infections.&nbsp;“It’s been around for a very long time,” he said of benzalkonium chloride. “I try to steer patients away from it.”Rontal also questioned the testing process used by British researchers in declaring the antiseptic successful against COVID-19.“It’s not a double-blinded study, so we don’t know if there’s an inherent bias,” Rontal said. “And so far the data that has been done in humans (about benzalkoium chloride) is contradictory to this. I would be uncomfortable to recommend this to anybody.”Rontal said he understands the medical community’s desire to find a cure or treatment for COVID-19, but cautioned against moving too quickly.“We’re all desperate for some sort of treatment,” Rontal said. “Everyone’s nervous and we’re all researching for something that’s going to be the magic cure. But we need to adequately study things before we get our patients into trouble.”This is the first “nanotechnology” product to go to market for BlueWillow, which for years has operated as a clinical-stage biopharmaceutical company, which means it has several drugs in various stages of development and products in the pipeline pending approval.The company was founded as a spin-off from the University of Michigan&nbsp;—&nbsp;where the "nanotechnology" was first developed — and was initially focused on developing nano-scale dermatology applications. Michigan Medicine declined comment on the new antiseptic.Over the years, the firm&nbsp;has worked on multiple research projects through the&nbsp;Gates Foundation, NIH and Department of Defense contracts.“It’s been a long hard process,” said Peralta, noting the company has seen $190 million in research expenses over the years.&nbsp;“There are many days when you’re not sure you’re going to survive.”But then came the pandemic.&nbsp;"During this difficult time, doctors and nurses who are treating patients need every protective measure possible," said Dr. Michael Corrado, a fellow at the Infectious Disease Society of America and former vice president of clinical research at Johnson &amp; Johnson. "Even though BlueWillow's nasal antiseptic hasn't yet been clinically tested to confirm protection against COVID-19 infection, it has demonstrated both anti-bacterial and anti-viral activity in laboratory tests making it a potentially important additive measure to hand washing and barrier techniques for healthcare workers on the front lines."“This is the most exciting opportunity I’ve seen in my life to make a difference for a large number of people,” said Costley. “We’ve been at this a long time. That we can finally make it to market – that’s incredibly exciting.”Contact Tresa Baldas:tbaldas@freepress.com.

Detroit Free Press With the blessing of British scientists, a Michigan bio-pharmaceutical company is hitting the market with an over-the-counter nasal antiseptic that it says has killed COVID-19 in lab tests.Neither the Center for Disease Control nor the FDA have conducted trials to know whether the antiseptic can actually kill COVID-19. And the makers stress: "It's not a cure."But scientists at BlueWillow Biologics in Ann Arbor believe they are onto something.&nbsp;This month, the company announced that laboratory studies by Public Health England show that their antiseptic has the ability...

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Tresa Baldas

The Detroit Free Press is the largest daily newspaper in Detroit, Michigan, US. The Sunday edition is titled the Sunday Free Press. It is sometimes referred to as the Freep (reflected in the paper's web address, www.freep.com). It primarily serves Wayne, Oakland, Macomb, Livingston, Washtenaw, and Monroe counties.  The Free Press is also the largest city newspaper owned by Gannett, which also publishes USA Today. The Free Press has received ten Pulitzer Prizes and four Emmy Awards. Its motto is "On Guard for 189 Years".

Ann Arbor company says its nasal antiseptic can kill coronavirus

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