NanoViricides
to Participate
in Panel Discussion at the B. Riley FBR Virtual Infectious Disease
Summit
Today,
July 21, 2020
SHELTON,
CONNECTICUT — Tuesday, July
21, 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
Anil
R. Diwan, PhD, President and Executive Chairman of the
Company,
will participate in the
"B.
Riley FBR Virtual Infectious Disease Summit – Therapeutics
Day"
on Tuesday, July 21,
2020. The Conference is organized by B. Riley FBR, Inc.
(https://brileyfbr.com/).
Dr. Diwan is invited to participate in Panel #3 at 2020 at 2:10
p.m. ET,
entitled "Taming the Severe Disease
Presentations".
He will briefly discuss the Company's novel
nanomedicines
platform and the Company's progress in the lead IND-ready candidate
for the treatment of shingles rash, NV-HHV-101, as well as in
developing a drug candidate against SARS-CoV-2, the cause of
COVID-19 global pandemic.
The
Company believes that it is close to selecting a clinical candidate
worthy of advancing into human clinical trials for the treatment of
SARS-CoV-2 infection, based on (i) cell culture
effectiveness studies against multiple circulating coronaviruses
that employ different cell surface receptors, (ii) a lethal lung
infection animal model effectiveness study using hCoV-NL63
infection (a coronavirus that uses the same receptor, ACE2, as
SARS-CoV-2, and produced similar disease in the animal model), and
(iii) preliminary safety studies in animal model at maximum
feasible dosage levels. The Company has disclosed its findings from
these studies in previous press releases.
Prior to filing for human clinical trials, NanoViricides plans on
conducting studies, towards clinical candidate selection, to
further determine the effectiveness against SARS-CoV-2, perform
additional drug development studies as may be necessary, and
request a pre-IND Meeting with the US FDA for regulatory
guidance.
The Company is also
working
with its regulatory consultants on completing an IND with the US
FDA to advance its lead drug
candidate NV-HHV-101 into human
clinical trials for topical dermal treatment of Shingles
rash as the initial
indication. In particular, the
Company is working on finalizing the clinical trials plan for the
anticipated human clinical trials for shingles rash treatment. The
Company is also in the process of finalizing clinical trial sites.
This process has been adversely
affected
by the current global COVID-19 pandemic, and in particular,
its
effects across the USA.
Importantly, nanoviricides are designed to act by a novel mechanism
of action, trapping the virus particle like the "Venus-fly-trap"
flower does for insects. Antibodies, in contrast, only label the
virus for other components of the immune system to take care of. It
is well known that the immune system is not functioning properly at
least in severe COVID-19 patients.
Additionally, it is well known that viruses escape antibody-drugs
via mutations. The Company's "nanoviricide" drug candidates, in
contrast, are designed to be broad-spectrum, and therefore virus
escape by mutations is expected to be unlikely.
The market size for the treatment of shingles is estimated at
approximately one billion dollars
by various estimates. These estimates take into account the
Shingrix® vaccine as well as existing vaccines.
About 500,000 to 1 million cases of
shingles occur in the USA alone every year.
The market size for our immediate target drugs in the HerpeCide™
program is variously estimated at billions to tens of
billions of dollars. The Company believes that its dermal topical
cream for the treatment of shingles rash will be its first drug
heading into clinical trials. The Company believes that additional
topical treatment candidates in the HerpeCide™ program, namely,
HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment
are expected to follow the shingles candidate into IND-enabling
development and then into human clinical trials. These additional
candidates are based on NV-HHV-101, thereby maximizing return on
investments and shareholder value.
The Company develops its class of drugs, that we call
nanoviricides®, using a platform 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 a maximum of two attachment points
per antibody.
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 simultaneously (a) attacking
extracellular virus to
break the reinfection
cycle, and (b) disrupting intracellular production of the
virus, thus
enabling
complete control of a virus infection.
About NanoViricides
NanoViricides, Inc.
(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.
The
Company is in the process of
completing an IND application to the US FDA for this drug
candidate. The Company cannot project an
exact date for filing an IND because of its dependence on a number
of external collaborators and consultants, and the effects of
recent COVID-19 restrictions.
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