SHELTON, Conn., April 26, 2017 /PRNewswire/ -- NanoViricides,
Inc. (NYSE MKT: NNVC) (the "Company"), reports that Eugene Seymour, MD, MPH, CEO, will present
information about the Company and its progress towards human trials
at the Planet Microcap conference at the Planet Hollywood Hotel.
His talk is scheduled for 12:30pm PDT
on Thursday April 27th. The Planet
MicroCap Showcase brings together the most promising companies and
the top dealmakers in MicroCap Finance for three days of company
presentations, one-on-one meetings, and networking.
NanoViricides, Inc. is a global leader developing antiviral
nanomedicines for the treatment of a number of different viral
infections.
The Company is currently focused on developing its broad
spectrum anti-herpesvirus drug candidates. In particular, the
Company is working on moving its dermal topical treatment for
Shingles into human clinical trials as soon as possible.
NanoViricides has previously reported that its broad spectrum
anti-herpesvirus drug candidates were highly effective in treating
HSV-1 infection in a lethal animal model. In particular, topical
treatment with a Herpecide™ program drug candidate led to 80~100%
survival of animals lethally infected with HSV-1 H129c, wherein
untreated animals had 0% survival. The Company has since improved
on this candidate which has led to a franchise of topical drug
development opportunities in different indications with herpesvirus
infections.
The Company's HerpeCide™ program includes development of skin
cream/lotion for the treatment of (a) herpes labialis ("cold
sores") typically caused by HSV-1, (b) genital lesions typically
caused by HSV-2, (c) shingles (zoster), caused by reactivation of
the human herpesvirus-3 (HHV-3, aka Varicella-zoster virus or VZV,
which causes chickenpox and then goes dormant); and eye drops or
gel for the treatment of (d) herpes keratitis of the external eye
(caused primarily by HSV-1). The Company believes these four
indications encompass several billions of dollars in market
opportunity.
Of these, the Company believes that its drug candidate for the
topical (dermal) treatment of shingles would have the fastest drug
development path towards human clinical trials, and is working on
pre-clinical development of this drug candidate.
The Company believes that it is close to being able to declare a
clinical development candidate for the treatment of shingles, and
is now exploring further clinical development path for the
resulting drug candidate.
Professor Moffat's Lab at the State
University of New York Upstate Medical Center (SUNY-UMC) in
Syracuse is performing studies of the
NanoViricides shingles drug candidates in an ex vivo human
skin patch model of VZV infection. We believe that these human skin
patch studies should be highly predictive of human clinical trials
success. In addition, cell culture studies for optimizing the drug
candidates are being performed in our own laboratory. Certain
preliminary studies have been completed and repeat studies to
confirm the results are in progress.
The Company has also been working on scaling up production of
this drug candidate with the goal of developing 500g to 1kg per
batch production capability. The Company is currently performing
the Chemistry, Manufacture and Controls (CMC) studies needed for
filing an Investigational Drug Application (IND) for the shingles
drug candidate with the US FDA or equivalent application(s) in
other countries including Australia.
There is no effective treatment for shingles and the shingles
related pain complication called PHN (post-herpetic neuralgia). The
shingles associated debilitating pain usually lasts during the
infection outbreak in most patients, although in 75% of patients
over the age of 70, PHN can develop, which can last 90 days to even
a year or more in some cases even after the skin has healed.
Approved treatments for shingles and PHN include oral acyclovir
related nucleoside analogs that are given in very high doses
systemically for a week but with limited effect. A new oral
nucleoside analog called FV-100 is in Phase 3 clinical trials.
FV-100 development was previously abandoned by Bristol-Myers-Squibb
and is now undertaken by a small pharma.
A vaccine for shingles is available, that may reduce occurrence
of shingles as a preventive, but not as a treatment after an
outbreak occurs. The chickenpox vaccine is now standard for
children. In spite of this, the incidence of shingles in
adolescents and young adults is rising. Shingles generally occurs
in older people due age related decrease in immune function, and in
patients with immune function compromising conditions from stress
to organ transplant to other infections and HIV/AIDS.
Although in most patients, shingles is debilitating during the
outbreak but not life-threatening, in a small percentage of
patients, it can cause eye infections in the retina that can lead
to blindness.
There is no topical treatment for shingles. We believe this is
an unmet medical need. The market size for a successful topical
treatment for shingles could be in the billion dollar to
multi-billion dollar range.
The Company has eight different drugs in development, including
four indications in the HerpeCide program. This deep and wide
pipeline demonstrates the robustness of the nanoviricide® platform
technology. A "nanoviricide®", as defined by the Company, is a
chemical substance that mimics the receptors on human cell surface
to which the virus binds, and upon virus binding, the nanoviricide
is designed to engulf the virus and render it non-infectious, like
a Venus-Fly-Trap.
A nanoviricide drug candidate, when properly designed, would be
expected to continue to be effective in spite of the rapid
mutations that a virus undergoes, thereby escaping conventional
antiviral drugs, antibodies, and vaccines. This is because in
spite of the mutations, the virus continues to bind to the same
site on the same cell surface receptor(s), which a nanoviricide
mimics.
The nanoviricides mechanism of action is believed to mimic a
natural host cell receptor using which the virus binds and infects
cells; binding of a nanoviricide nanomicelle to the virus is
expected to render it non-infectious. A nanoviricide would thus
stop the spread of the viral infection to new uninfected cells.
This mechanism is different from that of currently available
anti-Herpesvirus drugs. The Company therefore believes that it is
able to develop broad-spectrum anti-herpes nanoviricide drugs.
NanoViricides, Inc. is one of a few bio-pharma companies that
has all the capabilities needed from research and development to
marketable drug manufacture in the small quantities needed for
human clinical trials. Our campus at 1 Controls Drive, Shelton, CT, has state of the art
nanomedicines characterization facilities that enable us to perform
IND-enabling nanomedicine analysis and characterization studies of
any of our various drug candidates in house.
All current topical drug candidates in our HerpeCide™ program
are variants of the shingles drug further optimized for the
specific herpesvirus and topical delivery constraints. These
topical treatments are expected to provide a significantly faster
path to human clinical stage than the injectable and oral drugs in
our pipeline.
Topical treatments for the herpesvirus indications are
important. Although the herpesviruses stay latent in a nerve
ganglion, the pathology of an outbreak in a patient begins with
reinfection in the skin layer from the reactivated virus, followed
by further expansion of the virus in the skin layer. The newly
produced virus then causes additional spread of the virus to more
nerve cells, and would become latent there. Topical nanoviricide®
treatment would stop further expansion of the virus at the site and
therefore should also potentially decrease further recurrences.
Also, topical treatment allows exposure of the virus to much higher
concentrations of the drug locally, and thereby should produce
greater effectiveness with less overall drug use, as compared to
systemic treatments.
All of the biological testing and characterization of our drug
candidates continues to be performed by external academic or
institutional collaborators and contract research organizations
(CRO). However, we now have our own capabilities to perform certain
cell culture based drug candidate screening for BSL2 viruses, which
includes herpesviruses. We believe that this is speeding up our
drug development programs against such viruses significantly by
removing the latencies of external testing in the earlier drug
screening and the later drug optimization stages.
The Company has established additional collaborations towards
IND-enabling development of drug candidates against the four
HerpeCide program indications listed above. We now have
collaboration agreements with the CORL at the University of Wisconsin, and the Campbell Lab at
the University of Pittsburgh, for the
evaluation of its nanoviricides® drug candidates in models of
ocular herpesvirus and adenovirus infections. TransPharm
Preclinical Solutions, a CRO, will continue to perform testing of
our anti-herpes drug candidates in dermal infection models. In
addition, we have a collaboration with Professor Moffat Lab at SUNY-UMC to study our drug
candidates against shingles.
NanoViricides has previously reported that it has sufficient
cash in hand to be able to take at least one of its drug candidates
into initial human clinical trials. The Company believes that it
continues to be on track with this goal.
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. The Company is developing drugs
against a number of viral diseases including H1N1 swine flu, H5N1
bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral
diseases of the eye including EKC and herpes keratitis, Hepatitis
C, Rabies, Dengue fever, and Ebola virus, among others.
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.. Although it is not possible to
predict or identify all such factors, they may include the
following: demonstration and proof of principle in pre-clinical
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.
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SOURCE NanoViricides, Inc.