NanoViricides, Inc.
Pan-coronavirus Clinical Drug Candidates for the Treatment of
COVID-19 Are Highly Effective in Pre-clinical Cell Culture Studies
Performed in Preparation of FDA Pre-IND Application
Shelton, CT -- March 2, 2021 -- InvestorsHub NewsWire --
NanoViricides, Inc. (NYSE
American: NNVC) (the "Company") a leader in the
development of highly effective antiviral therapies based on a
novel nanomedicine technology platform, reported today on the
strong pan-coronavirus effectiveness of its two COVID-19 clinical
drug candidates for which the Company is preparing a pre-IND
application.
NV-CoV-2 is the Company’s broad-spectrum anti-coronavirus
clinical lead drug candidate for the treatment of COVID-19 patients
based on its nanoviricides® platform. In addition, the Company is
also developing NV-CoV-2-R, a drug treatment that combines the
power of both NV-CoV-2 and remdesivir in a single drug that
encapsulates and protects remdesivir inside NV-CoV-2.
Both NV-CoV-2 and NV-CoV-2-R are expected to work against most,
if not all, coronaviruses and their variants, based on the
Company’s findings on their pre-clinical effectiveness discussed
below. NV-CoV-2-R is designed to attack both (1) the virus
reinfection cycle outside cells, and (2) the virus replication
cycle inside cells. NV-CoV-2-R is thus potentially a cure for
COVID-19 infection by virtue of attacking the total virus
lifecycle.
NV-CoV-2 and NV-CoV-2-R were found to be highly effective in
comparison to remdesivir against two distinctly different
coronaviruses in our new cell culture studies leading towards a
pre-IND application and thereafter an IND submission for these
COVID-19 drug candidates. Remdesivir is one of the most effective
anti-coronavirus drugs in cell culture studies. Therefore our
finding that NV-CoV-2 was highly effective and comparable to
remdesivir in activity in these cell culture studies was pleasantly
surprising. Even more striking was the finding that NV-CoV-2-R
exceeded the effectiveness of remdesivir itself in these cell
culture studies. These results indicate that NV-CoV-2 and
NV-CoV-2-R could be some of the strongest weapons in the fight
against coronaviruses and the current COVID-19 global
pandemic.
The strong effectiveness of the three drugs NV-CoV-2,
NV-CoV-2-R, and remdesivir against two unrelated coronaviruses
(namely hCoV-NL63 and hCoV-229E) indicates their strong potential
for treatment of coronavirus diseases including COVID-19,
irrespective of variants or coronavirus types. The broad-spectrum
effectiveness of the Company’s drug candidates is very important as
coronavirus variants that are reported to evade antibodies,
potentially causing disease in spite of vaccination, are becoming
widespread as the COVID-19 global pandemic is progressing into its
second year.
Remdesivir is known to be highly effective in cell culture
studies against many coronaviruses as well as Ebola and other
viruses. Thus NV-CoV-2-R can be expected to be at least as
effective as remdesivir against all of these viruses in cell
cultures. Moreover, NV-CoV-2-R would be expected to be
significantly superior to remdesivir in human clinical studies, if
our encapsulation process effectively protects remdesivir from
bodily metabolism as is anticipated.
Remdesivir (Veklury®, Gilead) has shown relatively weak
effectiveness in clinical studies in contrast to its extremely
strong effectiveness in cell culture studies. Scientists have
related this to the rapid metabolism of remdesivir in the blood
stream causing loss of clinical effectiveness.
The Company believes that encapsulation of remdesivir into the
nanoviricide NV-CoV-2 should protect it from bodily metabolism and
thereby enable strong clinical effectiveness of the combined drug
NV-CoV-2-R against COVID-19 variants as well as Ebola and possibly
many other viruses for the treatment of infected humans.
The Company studied the effectiveness of NV-CoV-2, NV-CoV-2-R
and remdesivir against two unrelated human coronaviruses:
h-CoV-229E (229E), and h-CoV-NL63 (NL63). Of these NL63 uses the
same ACE2 human cell receptor to gain entry into cells as do all
variants of SARS-CoV-2 and SARS-CoV-1. Additionally, human
pathology of NL63 infection closely mimics that of SARS-CoV-2,
albeit with limited disease severity. NL-63 is being used as a
model for anti-SARS-CoV-2 drug development in various labs
including ours (see Chakraborty and Diwan for a
review1). In contrast, 229E uses the
cell surface receptor APN for entry rather than ACE2, and causes
common colds. Thus, NL63 and 229E are unrelated human
coronaviruses.
The Company intends to report on the results of these studies in
its pre-IND application to the US FDA to obtain guidance regarding
human clinical trials for treatment of COVID-19 patients.
Additionally, the Company is actively seeking opportunities to
engage appropriate sites for human clinical trials. Further, the
Company is engaged in the preparation of clinical trial protocols
and other activities that would be necessary for submitting an IND
application to the US FDA.
The Company has developed NV-CoV-2 based on its platform
nanoviricides® technology. This approach enables rapid development
of new drugs against a number of different viruses. A nanoviricide
is a “biomimetic” - it is designed to “look like” the cell surface
to the virus. The nanoviricide technology enables direct attacks at
multiple points on a virus particle. It is believed that such
attacks would lead to the virus particle becoming ineffective at
infecting cells. Antibodies in contrast attack a virus particle at
only two attachment points per antibody.
It is anticipated that when a virus comes in contact with the
nanoviricide, not only would it land on the nanoviricide surface,
binding to the copious number of ligands presented there, but it
would also get entrapped because the nanomicelle polymer would turn
around and fuse with the virus lipid envelope, harnessing a well
known biophysical phenomenon called “lipid-lipid mixing”. In a
sense, a nanoviricide drug acts against viruses like a
“venus-fly-trap” flower does against insects. Unlike antibodies
that tag the virus and require the human immune system to take over
and complete the task of dismantling the virus, a nanoviricide is a
nanomachine that is designed to not only bind to the virus but
also complete the task of rendering the virus particle
ineffective.
In addition, the nanoviricide technology also simultaneously
enables attacking the rapid intracellular reproduction of the virus
by incorporating one or more active pharmaceutical ingredients
(APIs) within the core of the nanoviricide. The
nanoviricide® technology is the only technology in
the world, to the best of our knowledge, that is capable of both
(a) attacking extracellular virus, thereby breaking the
reinfection cycle, and simultaneously (b) disrupting
intracellular production of the virus, thereby enabling complete
control of a virus infection.
The Company has developed NV-CoV-2-R based on this encapsulation
capability that is built in its nanoviricide NV-CoV-2. The Company
has chosen to encapsulate remdesivir as the participating drug for
blocking the viral replication cycle. Remdesivir is approved by the
US FDA for the treatment of patients hospitalized with COVID-19.
Encapsulation of remdesivir in the Company’s nanoviricide envelope
is expected to protect it from metabolism in the body. This
protection can be expected to lead to significant enhancement in
the effectiveness of remdesivir itself (in the encapsulated form),
by potentially increasing both the effective remdesivir
concentration and the duration of action. This could be an
additional favorable effect for the Company’s anti-coronavirus drug
candidate NV-CoV-2-R. Remdesivir is sponsored by Gilead. The
Company is developing its drug candidates independently at
present.
- Chakraborty and A. Diwan (2020). “NL63: A Better Surrogate
Virus for studying SARS- CoV-2”. Integr Mol Med, 2020,
vol.7, pp 1-9, doi: 10.15761/IMM.1000408.
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 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 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
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.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
Source: NanoViricides, Inc.
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