SHELTON, CONNECTICUT – May 16, 2022 — NanoViricides, Inc. (NYSE American: NNVC) (the “Company”) a global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform reports that it has begun drug development to combat recent cases of severe pediatric hepatitis. Specifically, the Company has initiated a program to screen its library of broad-spectrum antiviral nanoviricides against human Adenovirus 41 Type F (hAd41-F), believed to be strongly associated with the occurrence of severe hepatitis syndrome in some children, causing liver transplants as well as fatalities in large percentages of cases.
The Company’s top priority remains initiating human clinical trials of its SARS-CoV-2 drug candidate NV-CoV-2 to combat COVID-19. The Company expects filing of a clinical trial application for COVID-19 to take place fairly soon, although the timelines are outside the Company’s control.
The Company has previously successfully developed a drug candidate that was shown to be highly effective in animal studies against adenoviral Epidemic Kerato-Conjunctivitis (EKC), a candidate that is presently in the Company’s pipeline for further clinical development.
The Company believes it can successfully develop a drug candidate against hAd41-F in a relatively short period of time, if one or more of its existing pipeline candidates or other nanoviricide candidates in its drug candidate library are found to be effective. To this end, the Company is developing an antiviral assay for testing these drug candidates against hAd41-F infection in cell cultures in its own BSL2 Virology facility.
Adenovirus-41, Type F (hAd41-F) is widely believed to be the cause of the growing number of hepatitis cases in children worldwide that have required liver transplants and have reported fatalities. It is thought that a combination of prior SARS-CoV-2 exposure or infection, along with a current hAd41-F infection, may be responsible for this devastating syndrome, although no definitive cause of this severe hepatitis syndrome has been established. The number of cases worldwide has risen to 450 as of May 15, 2022 as reported by NBC News online. In the USA, the CDC has reported more than 110 cases, with more than 90% requiring hospitalization, of which 14% required liver transplants, and at least 1 fatality, with an additional 5 fatalities under investigation of whether they were caused by the same syndrome (https://www.nbcnews.com/health/health-news/symptoms-possible-causes-mysterious-child-hepatitis-cases-rcna28788 . See also: https://www.cnn.com/2022/05/06/health/hepatitis-kids-cdc-update/index.html ).
The Company plans to first screen its novel nanoviricides that have been effective against different viruses, including adenoviruses, against hAd41-F once the antiviral assay is established.
NanoViricides is one of a few biopharma companies that has its own cGMP-compliant manufacturing facility. The Company intends to produce its drugs for clinical trials in this facility. The Company has the capability to produce sufficient drugs for about 1,000-5,000 patients in a single batch of production, depending upon the drug and the dosage. This production capacity is anticipated to be sufficient for the Phase I and Phase II human clinical trials for our anti-coronavirus drug candidate NV-CoV-2, as well as for the anticipated clinical trials of NV-HHV-101 skin cream for the treatment of shingles.
The Company has previously completed IND-enabling studies for another drug candidate, NV-HHV-101 for the treatment of shingles rash caused by reactivation of the chickenpox virus (aka varicella-zoster virus, VZV). The Company plans on further developing the shingles drug candidate into human clinical trials after clinical trials of our COVID-19 drug candidate. The Company has additional drugs in its pipeline at various pre-clinical stages that it plans to develop towards regulatory approvals after the COVID-19 and Shingles drug clinical trials.
While adenoviruses are non-enveloped, the Company’s success in developing a highly effective anti-adenovirus nanoviricide to treat EKC is thought to be because of an attack of the nanoviricide onto adenovirus particle uprooting its fibers that are needed for attachment to the human cell, and possibly disruption of the viral capsid integrity by hydrophobic interactions of the nanoviricide’s lipid chains with the capsid penton and hexon protein structures of the virus particle. Type F adenoviruses and the EKC-causing adenoviruses are substantially different in their cellular receptor homing, and thus tissue tropism, as well as their structure. Thus Type F adenoviruses bear two types of fibers, short and long, both of which are required for successful cell infection whereas other adenoviruses possess only long fibers. Most adenoviruses including Type F adenoviruses use Coxsackie-Adenovirus Receptor (CAR) and certain integrins as the cellular receptors. The type F adenoviruses use laminin-binding-integrins, in contrast to the RGD-binding integrins that other types have affinity for. With these differences, although it is possible that the Company’s EKC drug candidate shows efficacy against hAd41-F, it is not a certain and therefore experimental screening of the Company’s library will be the first step in the Company’s Type F Adenovirus program.
NanoViricides, Inc. (the “Company”)(www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, we are developing a clinical candidate for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. The Company cannot project an exact date for filing an IND for this drug because of its dependence on a number of external collaborators and consultants.
The Company is now working on tasks for completing an IND application. The Company is currently pursuing two separate drug candidates for the treatment of COVID-19 patients. NV-CoV-2 is our nanoviricide drug candidate that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate that is made up of NV-CoV-2 with remdesivir encapsulated in it. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
The Company intends to re-engage into an IND application to the US FDA for NV-HHV-101 drug candidate for the treatment of shingles once its COVID-19 project moves into clinical trials, based on resources availability. The NV-HHV-101 program was slowed down because of the effects of recent COVID-19 restrictions, and re-prioritization for COVID-19 drug development work.
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 and Ebola/Marburg viruses. The Company has executed a Memorandum of Understanding with TheraCour that provides a limited license for research and development for drugs against human coronaviruses. The Company intends to obtain a full license and has begun the process for the same. The Company’s technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas 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.
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.
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.
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