http://www.nanoviricides.com/
NanoViricides, Inc.
NYSE: NNVC
A New Era in Targeted Anti-Viral Therapeutics.
NanoViricides, Inc. (NYSE: NNVC) 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.
Their 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 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, Inc. (NYSE: NNVC) 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 and 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 first-in-human use in the current SARS-CoV-2 pandemic for their anti-coronavirus drug in development, as well as for the anticipated clinical trials of NV-HHV-101 skin cream for the treatment of shingles.
The COVID-19 Opportunity
It has become clear with the advent of the Omicron sub-variant BA.2.12.1 and other sub-variants that the pandemic is not yet over….
With the evolution of variants, vaccine efficacy has decreased significantly, even with booster shots.
The limitations of vaccines and booster shots in combatting a viral pandemic have become abundantly clear through the course of the last two years. The fact that viruses escape vaccines and antibody drugs has also become amply evident.
NanoViricides, Inc. (NYSE: NNVC) is pursuing a clinical trial application for its lead drug candidate for the treatment of COVID-19, NV-CoV-2. This drug candidate is designed to act by a novel mechanism of action, that we call "Re-infection Blocker".
NV-CoV-2 was found to be a broad-spectrum, pan-coronavirus drug candidate in pre-clinical studies.
Highly effective antivirals such as NV-CoV-2 are desperately needed for the world to return to normalcy, as evidenced by the significant interest in antiviral drugs such as remdesivir (Gilead), molnupiravir (Merck), Paxlovid (Pfizer), and a few others in development!
Escape of virus due to variants is expected to be highly unlikely because of this broad-spectrum antiviral activity of NV-CoV-2. NV-CoV-2 was also found to be significantly more effective than remdesivir in animal studies of lethal direct lung coronavirus infection that simulates the SARS-CoV-2 disease. Remdesivir is so far the only fully-approved drug for the treatment of SARS-CoV-2 (COVID-19) at present.
NV-CoV-2 has been found to be extremely safe and non-mutagenic in GLP and Non-GLP Safety/Toxicology studies.
NanoViricides, Inc. (NYSE: NNVC) has also developed Oral Syrup and "Oral Gummies" formulations of NV-CoV-2 for oral administration. The Company has begun cGMP-compliant manufacturing operations for the production of a large batch of the drug substance and the drug products NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies for upcoming anticipated human clinical trials for COVID-19.
Clinical trial protocol for evaluation of safety and preliminary evaluation of efficacy upon oral administration of NV-CoV-2 has been defined and agreed with certain consultants already. The Company reports that it is now in the final stages of preparing the documents for submission of a clinical trial application.
Oral gummies are expected to be more readily acceptable to children and older patients because of slow dissolution in the mouth and palatability, than oral pills that may be difficult to swallow. NV-CoV-2 has demonstrated good oral bioavailability in animal studies. The Company believes that an effective oral drug to treat COVID-19 remains an unmet medical need given the limitations of available oral drugs!
The Company has also developed NV-CoV-2 formulations for injection, infusion and direct lung inhalation using a simple mouthpiece. The inhalation drug formulation is expected to benefit severely ill patients as it enables delivering much higher levels of drug (than infusion or oral dosing) directly to the lung tissue thereby helping to minimize the lung viral load and lung damage, which is expected to lead to rapid recovery of hospitalized patients.
The Need to Stop the Hepatitis Outbreak in Children
NanoViricides, Inc. (NYSE: NNVC) also recently disclosed that it has begun work on developing an antiviral drug against human Adenovirus-41, Type F (hAd41-F), which 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.
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