NanoViricides Completes Oral Gummies
and Lung Inhalation Formulations Development for its Non-Mutagenic,
Safe, Broad-Spectrum COVID-19 Clinical Drug Candidate,
NV-CoV-2
Shelton, Connecticut --
(November 15, 2021) - NanoViricides,
Inc. (NYSE American:NNVC) (the "Company"), a leader in the
development of highly effective antiviral therapies based on a
novel nanomedicines technology, announced today that it has
developed oral gummies formulations of its Pan-Coronavirus COVID-19
Drug Candidate NV-CoV-2 to benefit non-hospitalized patients.
Additionally, the Company has developed formulations for direct
inhalation into lungs to benefit severely ill hospitalized
patients. The Company also reports strong safety of NV-CoV-2 on
several parameters in animal models.
NV-CoV-2 has
been found to be an Extremely Safe and Non-mutagenic Drug, as
described below:
The Company reports that NV-CoV-2 has
been found to be non-immunogenic and non-allergenic. Further, it
has not caused any hypersensitivity or adverse reactions at
injection site or other adverse events in multiple animal
studies. It was safe and well tolerated at very high dosages
in single and multiple-dosing studies below the maximum tolerable
dose (MTD) in animal models, based on available data. The maximum
tolerable dosage in rats was determined to be 1,500
mg/Kg.
The Company also reports that NV-CoV-2
has been found to be non-mutagenic in a standard GLP Ames
Test.
The Company believes that the extremely
strong safety observed in animal models should be indicative of a
strong safety signal anticipated in Phase 1 human clinical
trials.
The non-immunogenicity,
non-allergenicity, and lack of hypersensitivity or adverse
reactions at injection site seen in animal models with single and
repeated injections leads the Company to postulate that it may be
possible to give a therapeutic dose of NV-CoV-2 in humans via a
simple slow-push injection rather than an infusion. If this proves
out in clinical trials, it would enable treating moderate cases
without hospitalizing the patients. This is an important unmet need
that would help significantly reduce the severe and intense load on
hospitals and health-care workers that occurs during the waves of
the global COVID-19 pandemic.
NV-CoV-2 and
NV-CoV-2-R Drug Formulations for Oral, Injectable, Infusion, and
Direct Lung Inhalation:
NanoViricides has developed
formulations of both NV-CoV-2 and NV-CoV-2-R to meet the needs of
different levels of disease severity and different types of
patients.
The Company has recently completed the
development of an oral gummies ("chewable gel") formulation of
NV-CoV-2. The Company believes that this formulation may have
advantages in terms of drug bioavailability over oral pills,
because of partial sublingual absorption that avoids the
gastrointestinal tract. NanoViricides maintains that this oral
gummies formulation would be very attractive to patients,
especially children, over oral pills. This formulation would be for
the benefit of symptomatic non-hospitalized patients, Additionally,
the simplicity of administration is expected to enable its
prophylactic use as well.
The Company has previously developed an
injectable formulation of NV-CoV-2 that it believes may not require
infusion, allowing treatment of severe cases without
hospitalization. This is an important unmet need for reducing strain
on hospital systems during waves of the global COVID-19
pandemic.
Previously, the Company has developed
formulations for infusion for both NV-CoV-2 and NV-CoV-2-R, to
treat severely ill hospitalized patients.
NanoViricides has also very recently
developed formulations of both NV-CoV-2 and NV-CoV-2-R for direct
inhalation into lungs using a simple nebulizer. This inhalation
formulation is developed to benefit very severely ill patients with
significant lung pathology. Direct inhalation of the drug would
result in highest possible levels of the drug to be achieved in
lungs thereby maximizing antiviral effect, and minimizing lung
viral load. This is expected to help minimize lung damage, enabling
the patient to recover rapidly.
The Company has previously demonstrated
that NV-CoV-2 was highly effective in multiple cell culture studies
against unrelated coronaviruses including SARS-CoV-2 (S-protein
pseudovirion), h-CoV-NL63 (NL63), and h-CoV-229E (229E). 229E
causes common colds. NL63 causes a COVID-19-like lung pathology in
humans, but the disease is not very severe. SARS-CoV-2 has caused
the current global pandemic that continues with multiple waves
driven by evolution of new variants. Thus the Company has
established the broad-spectrum pan-coronavirus activity of
NV-CoV-2.
As new variants emerge, the
effectiveness of vaccines has continued to drop, the protection
from the antibodies developed in response to the vaccine has
continued to decrease, and antibody drugs have become progressively
less effective. Thus a broad-spectrum pan-coronavirus drug is
needed to help end the pandemic. NanoViricides has recognized this
need right at the onset and believes it has successfully developed
drug candidates that precisely satisfy this as-yet unmet
need.
NanoViricides asserts that there is a
much lower probability of generation of escape mutants against
NV-CoV-2 (as compared to the classical types of drugs) (1) because
it is designed to create a multi-point attack on the virus thereby
completely disrupting the virus structure, and (2) because of the
observed broad-spectrum activity of NV-CoV-2 against multiple types
of distinctly different coronaviruses including
SARS-CoV-2.
"We believe that NV-CoV-2 and
NV-CoV-2-R would be highly effective drugs against SARS-CoV-2,
based on multiple animal studies data," commented Dr. Anil Diwan,
Chairman and President of the Company, adding, "We believe that
NV-CoV-2 may help end the pandemic if it is shown to be effective
in human clinical trials."
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.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
http://www.nanoviricides.com
Public Relations
Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
Source: NanoViricides,
Inc.
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