SHELTON, Conn., July 10, 2017 /PRNewswire/ -- NanoViricides,
Inc. (NYSE MKT: NNVC) (the "Company") reports that its
anti-shingles nanoviricides® drug candidates achieved dramatic
reduction in infection of human skin by the varicella-zoster virus
(VZV), the shingles virus. These findings corroborate the
previously reported findings of inhibition of VZV infection of
human cells in culture. VZV is restricted to human tissue and
only infects and replicates in human tissue.
Over the time course of VZV infection, the nanoviricides® drug
candidates showed marked inhibition of VZV infection, replication
and spread in human skin cultured ex vivo. The data
suggest that select nanoviricides® drug candidates may have direct
virucidal activity based on their antiviral effects within the
first 24 hours after viral infection.
The antiviral effect of certain nanoviricide drug candidates was
substantially greater than the effect of the standard positive
control of cidofovir added into media. Even more remarkably, the
effect of these nanoviricides drug candidates was equivalent to a
topical formulation of 1% cidofovir applied directly onto the skin
patch. A topical skin cream containing 2% cidofovir is clinically
used in very severe cases of shingles. However, the cytotoxicity of
cidofovir is known to cause ulceration of the skin to which it is
applied, followed by natural wound healing. We are awaiting
histopathology studies at present.
Since VZV causes skin lesions as a result of direct attack of
the re-awakened virus released from nerve endings onto the human
skin cells, this ex vivo human skin patch model involving VZV
infection of cultured human skin ex vivo is considered to be
a close representation of natural course of shingles.
The Company has previously reported that these same
nanoviricides® compounds displayed potent inhibition of VZV
infection of a human retinal epithelial pigment cell line in an
in vitro cell culture virus infection model with no evidence
of toxicity to the cells. These ex vivo and in
vitro studies are a critical step in the selection of final
clinical drug development candidates for safety and toxicology
studies with the goal of an IND submission to the FDA for the
topical treatment of shingles in humans.
"These human skin studies provide important validation of our
VZV project," stated Dr. Eugene
Seymour, MD, MPH, CEO of the Company, "and will expedite our
VZV drug development as well as our entire Herpicide™ drug
program."
The human skin studies were performed in the laboratory of Dr.
Jennifer Moffat at SUNY Upstate Medical University in Syracuse,
NY. The Company previously reported the collaboration with
Dr. Moffat, an internationally recognized expert on
varicella-zoster virus. She has extensive experience in
varicella-zoster virus (VZV) infection, pathogenesis, and
anti-viral agent discovery. The National Institutes of Health has a
contract with Dr. Moffat's lab for evaluating anti-viral compounds
against VZV, although the Company chose to set up a direct
collaboration with Dr. Moffat rather than going through the NIH
program.
"The nanoviricides® compounds we tested in the skin assays
showed clear evidence of anti-VZV activity," stated Dr. Moffat,
adding, "we are pleased that our results can be used to select the
most promising compounds."
The Company intends to produce the quantities of its drug
candidates necessary for all drug development activities including
safety and toxicology and initial human clinical trials at its
current facility in Shelton,
CT. The Company has continued to optimize the cost and time
efficiency of its manufacturing processes for the ligands, polymers
and final ligand-polymer nanoviricides® drug candidates.
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 VZV, 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.
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 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.