NanoViricides
Nominates a
Novel Candidate for Advancing Into
Clinical
Trials for Treatment of COVID-19
Shelton,
CT -- September 16, 2020 -- InvestorsHub NewsWire
-- NanoViricides,
Inc. (NYSE American: NNVC)
(the "Company") a global leader in the development of highly
effective antiviral therapies based on a novel nanomedicines
platform,
today announced that it
has nominated
a
clinical drug candidate for the treatment of
COVID-19, thus
further
advancing
its COVID-19 program closer to
human
clinical trials.
The
Company has accelerated its drug development program for COVID-19
with the goal
of
creating the most effective medicine to obtain
regulatory approval
for emergency use in the COVID-19 pandemic in the shortest
timeline feasible,
after
achieving
proof of concept of
broad-spectrum anti-coronavirus effectiveness of test
candidates.
The
Company therefore aggressively worked
to
harness the full power of the nanoviricides®
nanomedicine
platform
to achieve these objectives.
A
curative treatment for a virus such as SARS-CoV-2 coronavirus would
require a multi-faceted attack that shuts down (i) ability of the
virus to infect host cells and simultaneously, (ii) ability of the
virus to multiply inside the host cells. The nanoviricide®
platform
enables direct multi-point attack on the virus that is designed to
disable the virus and its ability to infect new cells. At the same
time, a nanoviricide
is also
capable of carrying payload in its "belly" (inside the micelle)
that can be chosen to affect the ability of the virus to replicate.
The nanoviricide
is
designed to protect the payload from metabolism in circulation.
Thus, the nanoviricide
platform
provides an important opportunity to develop a curative treatment
against SARS-CoV-2, the cause of COVID-19 spectrum of
pathologies.
The
clinical candidate the Company has chosen is identified as
NV-CoV-1-R. It is
made up of a nanoviricide
that we
have found to possess
broad-spectrum
anti-coronavirus activity, now identified as NV-CoV-1, and
remdesivir
encapsulated
inside the core of
NV-CoV-1.
NV-CoV-1
itself is designed to attack the virus particles themselves, and
possibly would also attack infected cells that display the virus
antigen S-protein, while sparing normal (uninfected) cells that do
not display the
S-protein.
Additionally, remdesivir
is widely
understood to attack the replication cycle of the virus inside
cells. Thus the combined attack enabled
by
NV-CoV-1-R on the virus could prove to be a cure for the
infection
and the disease, provided that the
necessary dosage level can be attained without undue adverse
effects. Human clinical trials will be required to determine the
safety and effectiveness of NV-CoV-1-R.
Remdesivir
is
a well-known
antiviral drug (developed
by
Gilead) that has been
approved for emergency use treatment of SARS-CoV-2 infection or
COVID-19 in several countries. NV-CoV-1 is a novel agent that is
being used as an adjuvant to remdesivir
in
creating NV-CoV-1-R, to improve the
overall effectiveness. It is well known
that remdesivir
suffers
from rapid metabolism in circulation that breaks down
the
prodrug
to its
nucleoside form which
is not
readily phosphorylated. The Company anticipates that encapsulation
in NV-CoV-1 may protect remdesivir
from
this rapid
metabolism. If this
happens, the effective level and stability
of
remdesivir
in the
body would increase. This
increase may lead to increased effectiveness if there are no
adverse effects. Such increased effectiveness, if found, may also
allow reduction in the required dosage of remdesivir
in the
encapsulated form, i.e. as NV-CoV-1-R. In this sense,
NV-CoV-1 can be viewed to act as an adjuvant that enhances the
effect of remdesivir,
a known antiviral against SARS-CoV-2.
"This is
an extremely important milestone for the Company," said Anil R.
Diwan, PhD, President and Executive Chairman of the Company,
adding, "We look forward to rapid development of the IND enabling
core safety pharmacology studies and, thereafter,
human
clinical development on an accelerated timeline in these
trying times
of the
pandemic."
About
NanoViricides
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 have
declared
a clinical development candidate, namely NV-CoV-1-R, which
encapsulates remdesivir
inside
NV-CoV-1, for the treatment of COVID-19. The Company cannot
project an exact date for filing an IND for NV-CoV-1-R
because of its dependence on a
number of external collaborators and
consultants.
The
Company is now working on performing required safety pharmacology
studies and completing an IND application for NV-CoV-1-R. The
Company believes that since remdesivir
already
has an emergency use approval, NV-CoV-1-R is likely to be an
approvable drug, if safety is comparable. Remdesivir
is
developed
by
Gilead. The Company has
developed NV-CoV-1-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.
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. CMC refers to "Chemistry, Manufacture, and
Controls".
Contact:
NanoViricides,
Inc.
info@nanoviricides.com
Public
Relations Contact:
MJ
Clyburn
TraDigital
IR
clyburn@tradigitalir.com
Source:
NanoViricides,
Inc.
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