Berliner Abendpost - NanoViricides Drug Can Fight Bird Flu Pandemic; H5N1 Virus Cannot Escape

An "opinion and analysis" article published in Scientific American on February 7^th correctly recognizes that the H5N1 "virus is versatile…and mutating", although it rapidly devolves into unwarranted and unsubstantiated inflammatory and false assertions against the Trump administration (https://www.scientificamerican.com/article/the-us-is-not-ready-for-bird-flu-in-humans/).

This article's titular declaration that the "US is not ready for bird flu in humans" is myopic.

We beg to differ from this opinion, and hereby declare that our broad-spectrum antiviral drug NV-387 that H5N1 virus will not be able to escape even as it changes in the field, is ready to fight the battle and save lives, should a human H5N1 pandemic occur.

The said article is basically an opinion that is clearly limited to partial and biased analysis of current drugs and vaccine efforts for H5N1, and demonstrates total unawareness (or ignorance) of the failures (or very limited successes) of antiviral vaccine, antibody and small chemical drug approaches during the COVID pandemic. To wit, during COVID pandemic, vaccinated persons were still infected with the virus because the virus was ever-changing, and they became unwitting carriers of the virus. Thus, vaccination did not break the chain of virus transmission, and the R0 number continued to increase throughout the pandemic despite compulsory vaccinations. The immunity from vaccines was not long-lasting, and now immunity from natural COVID infection is thought to have been superior to that provided by the vaccines.

"Vaccines are not the right response for fast-moving viruses such as SARS-CoV-2 or H5N1, because vaccine deployment is at least 12 to 15 months behind the virus, when the virus has already moved on," commented Anil R. Diwan, PhD, adding "We must learn from past pandemics and past mistakes. We believe that the iconoclastic Trump 2.0 administration will heed these lessons."

NV-387 is ready to be a significant part of the pandemic preparedness and response arsenal, because it has already demonstrated activity against different and varied viruses including Coronaviruses (COVID), Influenza viruses, RSV, and even Poxviruses (MPox/Smallpox). Its design is thought to enable this drug NV-387 to be able to fight as many as 90-95% of human pathogenic viruses, based on literature reports of the vulnerabilities of human pathogenic viruses.

The bird-flu virus and its variants are highly unlikely to escape the broad spectrum, host-mimetic, antiviral drug NV-387, because all of these variants continue to land on the same host-side feature that NV-387 mimics. Further, in stringent lethal animal model studies to treat Influenza A H3N2 infection, NV387 has shown superior activity compared to osletamivir (Tamiflu®), peramivir (Rapivab®), and baloxavir (Xofluza®); all of these approved small chemical drugs are prone to escape by the virus with just single point mutations.

"We believe that the new administration will focus on rapid development and acquisition of broad-spectrum therapeutic drugs like NV-387 that the virus cannot escape, for the Nation's arsenal of antiviral weaponry, in order to prepare for not just a potential bird flu pandemic in humans but also potential spread of MPox outside of the African region, and potential Smallpox bioteerorism, all at the same time, with a single drug capable of fighting all of these fights, thus saving billions of dollars to the American taxpayer, instead of the failed strategy of chasing viruses by continuing to develop new multi-billion-dollar vaccines every few months that was adopted by the Biden administration in response to the COVID pandemic," Dr. Diwan stated.

Vaccines will now also face an increased barrier of being able to win over people to voluntarily take the vaccine shot that the people already know offers limited protection because so many people experienced a COVID infection multiple times even after getting vaccinated, due to variants.

"The Biden administration propagated only vaccines and antibodies development under the COVID response and later Project NextGen funding. This was in spite of the fact that antibodies, although rapidly given emergency use authorizations by the FDA, were losing efficacy every few months, as soon as a new variant of SARS-CoV-2 appeared. And yet the Biden administration continued to chase the changing virus with new vaccines and new antibodies, resulting in an extremely costly approach with little to show for it. Despite this, under the Biden administration, HHS has already sent $590 million of taxpayer money to Moderna alone, among other vaccine funds recipients, in order to be prepared to be able to develop an accurate H5N1 vaccine if and when a pandemic occurs, even though the virus will be different from any that the $590 million are being spent on," said Diwan.

"I am certain the Trump 2.0 administration is in no mood to entertain such wasteful expenditures for H5N1 bird flu response," said Dr. Diwan, adding, "Everyone understands that a broad-spectrum drug that the virus cannot escape is an essential part of an excellent multi-pronged strategy for pandemic response."

"I implore the HHS Secretary nominee Robert F. Kennedy Jr. to take the lessons of COVID pandemic to heart, and produce a consummate response to Bird Flu. Just as the Trump 1.0 administration deployed Operation Warp-Speed to enable development of the first ever modern mRNA vaccine rapidly, a similar approach needs to be adopted to promote rapid development of new therapeutic drugs against bird flu that the virus would not escape, so that there is an arsenal of weapons against the virus to treat the infection and save lives, while there is still time," Diwan said.

Two different major genotypes of bird flu H5N1 are found to be circulating, both of which have caused infections in humans. A highly pathogenic genotype D1.1 from birds has led to one critical month-long illness in Canada and one death in the US signifying the potential for high morbidity and mortality from this genotype if it spreads in humans. A somewhat less pathogenic genotype B3.13 from dairy cows in several states including California has infected dairy workers that have recovered. In addition, D1.1 was recently found in milk from dairy cows in Nevada. Both genotypes are also found to be infecting many other mammals including cats, dogs and pigs. Dairy workers, persons exposed to wild birds or free-range flocks, and even veterinarians have been infected with bird flu.

Fortunately, there is no strong evidence of human to human transmission yet. Therefore, the threat of potential pandemic is still considered to be low. However, scientists have already found that a single point mutation in this virus can change that scenario quickly. Thus, the urgency of developing a viable broad-spectrum antiviral drug response is now immediate.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we are developing as a treatment of RSV, COVID, Long COVID, Influenza, H5N1 Bird Flu, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.

Contact:

NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

SOURCE: NanoViricides, Inc.

View the original press release on ACCESS Newswire

E.Fritsch--BlnAP