SHELTON, Conn., June 3, 2019
/PRNewswire/ -- NanoViricides, Inc. (NYSE American: NNVC) (the
"Company") a company with novel platform technology to fulfill
unmet medical needs in treating difficult and life-threatening
viral diseases, reports that it has received favorable comments
from the US FDA on the Company's pre-IND application for its lead
drug candidate.
The Company reports that the US FDA (the Agency) has generally
agreed in its pre-IND response that the plan of drug development
presented by the Company to the FDA is generally adequate at this
time. The Company received the response on May 23rd, 2019.
In particular, the Agency has agreed that the Company's strategy
for drug substance and drug product acceptance criteria is
adequate. The Agency has further agreed that the IND-enabling
non-clinical studies proposed by the Company are generally
adequate. The US FDA also said that the proposed design of the
IND-opening human clinical studies appears reasonable at this
time.
The FDA has made valuable suggestions in the pre-IND response.
The additional non-clinical studies recommended by the Agency are
generally consistent with the Company's planned IND-enabling
non-clinical studies. The Company has discussed the Agency's
comments and suggestions in detail with its regulatory consultants
from Biologics Consulting Group, VA.
"This is an important milestone that takes our lead drug closer
to an IND filing," commented Anil R. Diwan, PhD, President and
Executive Chairman of the Company, adding, "We are very pleased
with the FDA response."
The Company is now proceeding with completing the IND-enabling
studies, and is working towards engaging appropriate clinical study
sites and developing concrete clinical study plans.
The Company has chosen NV-HHV-101, a broad-spectrum drug
candidate in its HerpeCide™ program, as its lead candidate. This
candidate is formulated as a skin cream for the treatment of
shingles rash, the Company's first target indication. Shingles is
caused in adults by varicella zoster virus (VZV), the same virus
that causes chickenpox in children. The chickenpox virus remains
latent in the nerve ganglia, and breaks out into shingles rash
generally due to immune-compromised status. NV-HHV-101 is designed
to mimic the herpesvirus binding site on the herpesvirus entry
mediator (HVEM), the classical receptor for HSV-1 and HSV-2. The
Company found in its own work in cell culture studies that the same
drug, in addition to working against HSV-1 and HSV-2, also worked
against VZV, although it is not known in scientific literature
whether VZV uses HVEM to infect cells. The Company intends to
develop drugs for the HSV-2 ("genital ulcers") and HSV-1 ("cold
sores") indications as the VZV program moves into the
clinic.
The drug candidate NV-HHV-101 is a nanomedicine composed of a
flexible polymeric micelle "backbone" to which a number of small
chemical ligands are chemically attached. The ligands in this case
are designed to mimic the binding site of the herpesviruses on
HVEM, based on molecular modeling. NV-HHV-101 is expected to bind
to VZV via a number of binding sites (i.e. the ligands), thereby
encapsulating the virus particle and destroying its ability to
infect human cells. This "Bind, Encapsulate, Destroy" nanoviricide®
strategy is distinctly different from the mechanism of action of
existing antiviral drugs against VZV.
There is a significant unmet medical need for the topical
treatment of shingles rash. An effective therapy has been estimated
to have a market size into several billions of dollars, if it
reduces PHN incidence. An effective therapy against shingles rash
reduction alone is estimated to have a market size of several
hundred million dollars to low billion dollars. These market size
estimates have taken into account the potential impact of the new
Shingrix® GSK vaccine and the impact of the existing Zostavax®
vaccine.
The Company currently intends to perform clinical studies for
shingles rash reduction, which would enable a sub-billion dollar
market opportunity. As experience with the drug is developed, it
would be possible to extend the indication to cover PHN thereby
expanding the market opportunity.
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. The
Company's nanomedicines technologies are based on the TheraCour®
polymeric-micelle based nanomedicine technologies of TheraCour
Pharma, Inc., from which the Company has obtained licenses for
developing drugs against a number of viruses. A license for VZV is
in progress. 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 refers to
investigational drug application. API refers to active
pharmaceutical ingredient.
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SOURCE NanoViricides, Inc.