Star Metro - A Measles Drug with Strong Activity without Toxicity Can Be Available Now for Emergency Use, Says NanoViricides - NV-387 Broad-Spectrum Antiviral with Activity Against Measles Virus

Having a drug to treat patients has become of paramount importance, in view of the fact that the USA is about to return to an endemic playground for the Measles virus, with over 1,600 cases as of October 17, breaking a thirty-year-plus-long record this year¹.

"We have already developed an effective drug to respond to the Measles virus outbreaks spreading all across the country," said Anil R. Diwan, PhD, President.

"NV-387 can be used right away for emergency use in Measles cases," said Krishna Menon, VMD, MRCS, PhD, Consulting Scientist (Non-Clinical), adding, "With my extensive experience with non-clinical development of several marketed drugs, I can definitely say that NV-387 has excellent activity and safety in treating Measles virus infection."

Dr. Menon designed and conducted the humanized animal model studies for testing drugs against Measles virus infection. As such, he has hands-on experience with the effects of the drug NV-387. The data has provided compelling evidence that NV-387 is indeed highly effective in protecting the infected from the systemic effects of Measles infection.

"The drug is manufactured under GMP in the USA," added Jayant Tatake, PhD, Vice President of the Company.

NV-387 has already completed Phase I clinical trial in healthy subjects with no reported adverse events.

The Company has previously reported that in a humanized animal model of lethal Measles infection, NV-387 treatment increased survival of animals to 17 days on average compared to only 7.4 days in untreated animals, an increase of 130%. There were no signs of toxicity from the drug NV-387. Additionally, dose-dependent increase in survival was observed. In contrast, Ribavirin, an unapproved drug that may be used off-label for severe Measles cases as per CDC guidance, is known to be highly toxic.

The Company intends to support any Physician's Investigator Initiated New Drug Application (IIND) for emergency use of NV-387 for treatment of one or a few cases of Measles, as per FDA regulations. The Company requests physicians that would like to avail of this opportunity to contact us.

NV-387 is a revolutionary novel drug that defines a new mechanism of action, in that it attacks the virus particles and destroys them.

NV-387 is available as Oral Gummies, which dissolve slowly in the mouth; and do not require swallowing. Swallowing can be difficult for a patient in presence of a rash.

With Measles outbreaks spreading all across the country, the USA is expected to lose the Measles elimination status, and the virus would be considered endemic thereafter as it was before 2000. However, Measles is extremely contagious, and more than 95% population needs to be vaccinated to eliminate the disease. To complicate the matters, persons with weakened or otherwise affected immune systems do not benefit from vaccination because their immune system cannot mount response to the challenge.

Further, it has become clear in recent years that the Measles virus is drifting from the current vaccine strain (circa 1968) over the last fifty years, and there is evidence that some variants may have arisen that have greater resistance to the vaccine than in the past.

Thus a drug for combating this emerging infectious disease is important. Regulatory development of a drug specific for Measles is not cost-effective.

NV-387 can be readily developed for Measles through FDA licensure, because it is a multi-purpose, broad-spectrum antiviral. NV-387 is being developed to treat several different viral infections acquired by the respiratory route. The Company is working on regulatory development of NV-387 as a treatment for viral infections that include RSV, Influenza, Bird Flu H5N1, Coronaviruses, COVID-19, the epidemic-threat MPox and the bio-terrorism threat, Smallpox.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) 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 plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, 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

N.Fournier--SMC