NanoViricides Provides Update on Its Pan-Coronavirus COVID-19 Drug Development Program at Benzinga Healthcare Small Cap Conference
SHELTON, CONNECTICUT -- Friday, October 4, 2021 -- NanoViricides, Inc. (NYSE American: NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, presented an update of its Pan-Coronavirus COVID-19 Drug Development Program at the Benzinga Healthcare Small Cap Conference on September 30, 2021 at 10:10am EST.
In the "Pan-coronavirus Broad-spectrum Nanomedicines NV-CoV-2 and NV-CoV-2-R to Attack the SARS-CoV-2 Virus and its Variants in the Global Pandemic" presentation, Dr. Diwan discussed the current status of NanoViricides' COVID-19 drug development program.
An updated Corporate Presentation that encompasses Dr. Diwan's presentation at the Benzinga Conference will be available shortly on the Company's website on its home page (www.nanoviricides.com).
Highlights of the Presentation:
• TWO Drug Candidates, NV-CoV-2 and NV-CoV-2-R in Development to Enter Clinical Trials
• Both Possess Broad-Spectrum Activities Against Many Coronaviruses
o Both Are Thus Expected to Continue to Work Against Variants
o Even as SARS-CoV-2 Continues to Evolve with Increasing Resistance to Existing Drugs
o Variants Would Therefore Not be Able to Escape Our Drugs, Particularly NV-CoV-2-R
• Novel Mechanism of Action, Unlike Existing Drugs
• NV-CoV-2-R is the Only Drug in Development with a Dual Mode of Action
o Block Virus from Attacking Cells in the first place, and o Inhibit Virus Replication Inside Cells, Simultaneously
• NV-CoV-2-R is the Only Drug in Development that Blocks the Complete Lifecycle of the Virus
o NV-CoV-2 Component Neutralizes Virus Outside Cells Blocking Reinfection Cycle o Remdesivir Component Blocks the Replication Cycle Inside Cells
o Makes it very difficult for virus to escape the drug
• Animal Model Studies Have Indicated that Both NV-CoV-2 and NV-CoV-2-R are Substantially Superior to Remdesivir in Controlling Coronavirus Lethal Lung Infection
o Lifespan Extension Over Untreated Infected Animals:
• Remdesivir: 2.5 days (Only 50% Increase)
• NV-CoV-2: 14 days (180% Increase)
• NV-CoV-2-R: 16 days (220% Increase).
• Both NV-CoV-2 and NV-CoV-2-R are Extremely Safe
o NV-CoV-2 Well Tolerated at >3.3 g/kg Body Weight in Rats by I.V. Infusion
o NV-CoV-2-R Well Tolerated at >1.8 g/kg Body Weight in Rats by I.V. Infusion o Anticipate Substantial Therapeutic Margin of Safety in Clinical Studies
• Required GLP Safety/Toxicology Studies of NV-CoV-2 Completed
o No Respiratory or Neurological Function Adverse Effects in a GLP Rat Neuro- Pulmonary Model Studies
o No Cardiovascular Function Adverse Effects in a GLP Study in Cynomolgus Monkey (Non-Human Primate) Model
"Importantly, NV-CoV-2 can be administered orally, and was found to be effective given orally in an animal model," Dr. Diwan added, "Oral NV-CoV-2 should enable highly effective treatments for pediatric use, an urgent medical need that remains unmet with even the most talked about current drug developments".
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(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. We are developing clinical candidates for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. In addition, the Company has several antiviral programs in various pre-clinical stages.
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 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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