SHELTON, Conn., Oct. 5, 2021 /PRNewswire/
-- 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
-
- Both Are Thus Expected to Continue to Work Against
Variants
- Even as SARS-CoV-2 Continues to Evolve with Increasing
Resistance to Existing Drugs and Antibodies
- 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
-
- Block Virus from Attacking Cells in the first place, and
- Inhibit Virus Replication Inside Cells, Simultaneously
- NV-CoV-2-R is the Only Drug in Development that Blocks the
Complete Lifecycle of the Virus
-
- NV-CoV-2 Component Neutralizes Virus Outside Cells Blocking
Reinfection Cycle
- Remdesivir Component Blocks the Replication Cycle Inside
Cells
- 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
-
- 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
-
- NV-CoV-2 Well Tolerated at >3.3 g/kg Body Weight in Rats by
I.V. Infusion
- NV-CoV-2-R Well Tolerated at >1.8 g/kg Body Weight in Rats
by I.V. Infusion
- Anticipate Substantial Therapeutic Margin of Safety in Clinical
Studies
- Required GLP Safety/Toxicology Studies of NV-CoV-2
Completed
-
- No Respiratory or Neurological Function Adverse Effects in a
GLP Rat Neuro-Pulmonary Model Studies
- 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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About NanoViricides
NanoViricides, Inc. (the "Company")
(http://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 for its COVID-19 drug candidates. 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 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
Coronavirus infections, 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'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
that 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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