NanoViricides Inc. (NNVC)

[drkazmd65]

A lot of words to say almost nothing of value this morning - Just get a clinical trial started already Diwan.

NanoViricides is Expanding its Broad-Spectrum Antiviral Program to Explore Further Antiviral Applications of its COVID Clinical Drug Ingredient
6:45 AM ET 4/25/23 | Dow Jones

SHELTON, CT / ACCESSWIRE / April 25, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform, reports that it is exploring additional antiviral applications for NV-387, the active pharmaceutical ingredient used in NV-CoV-2, the Company's COVID clinical drug candidate.

NV-387 has been found to have broad-spectrum activity against all of the tested seasonal coronaviruses and SARS-CoV-2 in pre-clinical studies. This activity is thought to be because NV-387 was designed to mimic a well known feature on human cell surfaces, called "sulfated proteoglycans" that a large number of virus families bind to as the first step in infecting a cell (reviewed in ([1]) ). Therefore, it can be anticipated that NV-387 may possess significant antiviral activity against many other virus families in addition to coronaviruses.

Antibiotics such as penicillin attack the bacterial surface and thereby kill the bacteria. Similarly, NV-387 is designed to attack the viral surface and destroy the virus particle. Similar to antibiotics that possess a broad-spectrum to treat bacterial infections, NV-387 could be a much needed broad-spectrum, direct acting, antiviral agent to treat multiple different viral infections.

Having a safe and effective broad-spectrum antiviral agent such as NV-387 in hand would help combat future viral infection epidemics before they expand. This strategy should form a backbone of pandemic preparedness strategy, rather than reliance on vaccines and antibodies that have now been proven to be of limited durable utility.

Once NV-387 successfully undergoes Phase 1 Safety Clinical Trials, further applications of NV-387 to other diseases would be eligible to directly proceed to Phase 2 Efficacy Clinical Trials in many cases. This would save the Company a substantial amount of time and money investment to bring additional drugs against other viruses based on this platform forward towards approval, significantly improving the return on investment.

To this end, the Company has undertaken pre-clinical studies of NV-387 against a number of other virus families of interest. As previously announced, we are working on poxvirus family therapeutics including mpox based on NV-387. Further, we are also working on Respiratory Syncytial Virus (RSV), and plan to work on other viruses that cause lung infections, such as parainfluenza viruses, and human metapneumovirus. We plan to continue to add to this list with both internal and external efforts. Some of the other important viruses that are known to bind to sulfated proteoglycans include chickengunya virus (CHKV), human papillomavirus (HPV), Ebola and Marburg viruses (EBOV, MARV), Hendra and Nipah viruses, Rabies virus, Norovirus, and Rhinoviruses. There are no safe and effective treatments for most of these viruses at present.

A safe and effective broad-spectrum antiviral drug that can treat all segments of patient population remains an unmet medical need, not only for COVID, but also for many other viral infections including RSV. While there are other broad-spectrum antivirals available, their high toxicities (e.g. cidofovir, brincidofovir, ribavirin) or poor effectiveness (e.g. favipravir) severely limit their applicability. NV-387 could be in a unique position to fulfill this unmet medical need.

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(R) class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of COVID caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials.

NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. 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 is also developing a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. NanoViricides' platform technology and programs are based on the TheraCour(R) 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 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 poxviruses, enteroviruses, and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. 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.

Disclosure Statement

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 that are, in some cases, beyond the Company's control and that 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. In particular, 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 in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program.

ICH refers to The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 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".

Contact:

NanoViricides, Inc.

[e-mail]

Public Relations Contact:

MJ Clyburn

TraDigital IR

[e-mail]

([1]) Cagno V, Tseligka ED, Jones ST, Tapparel C. Heparan Sulfate Proteoglycans and Viral Attachment: True Receptors or Adaptation Bias? Viruses. 2019 Jul 1;11(7):596. doi: 10.3390/v11070596. PMID: 31266258; PMCID: PMC6669472.

SOURCE: NanoViricides, Inc.

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