NanoViricides
Has Engaged Calvert Labs for Safety Pharmacology Studies of Its
Drug for the Treatment of COVID-19
Shelton,
CT
/ InvestorsHub NewsWire /
November 11,
2020/ --
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 reported
that it
has engaged Calvert Labs,
a contract research organization ("CRO"),
for performing the Safety Pharmacology studies of its
clinical
drug candidate for the treatment of COVID-19.
The
Company has been diligently
working on advancing its drug candidates for the treatment of
COVID-19 towards human clinical trials as rapidly as
feasible.
The
Company intends to perform certain core safety pharmacology studies
to ensure safety of the drug candidates at Calvert
Labs. The data from these
studies will be used for filing an IND application. Prior to that,
the Company also intends to file a pre-IND application with the
U.S. Food and Drug
Administration
("FDA")
to obtain
guidance.
The
recent increase in COVID-19 cases worldwide has led scientists to
suggest that this pandemic virus is expected to become a
circulating virus. Influenza viruses and common cold viruses are
other examples of circulating viruses. However, SARS-CoV-2 is more
virulent, and thereby causes substantially greater morbidity and
mortality than these other circulating viruses. Therefore,
development of an effective drug to treat the disease caused by
SARS-CoV-2 is very important.
A
curative treatment for a virus such as SARS-CoV-2 coronavirus would
require a multi-faceted attack that shuts down (i) the
ability
of the virus to infect host cells and simultaneously
and
(ii)
the
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.
About Calvert Labs
For more
than 40 years, Calvert Labs has been working with clients to help
them develop the next generation of therapeutics aimed at extending
and improving human life. Calvert
are
a
collaborative development partner bringing extensive experience, an
innovative, solutions-oriented approach and unsurpassed performance
to your preclinical drug development programs.
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 are developing a
clinical candidate for the treatment of COVID-19 disease caused by
SARS-CoV-2 coronavirus. 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 now working on performing required safety pharmacology
studies and completing an IND application. The Company believes
that since remdesivir
already
is 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 our own drug
candidates 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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