SHELTON, Conn., April 9, 2018 /PRNewswire/ -- NanoViricides,
Inc. (the "Company") reports that its drug candidates in the
HerpeCide™ program have been found to be safe based on multiple
parameters in the recently completed initial non-GLP
safety/toxicology study.
No clinically observable adverse safety and toxicology effects
were seen in this study of the Company's optimized topical dermal
drug candidates.
These drug candidates will now advance towards the full battery
of GLP safety and toxicology studies that are needed for filing an
Investigational New Drug (IND) application with the US FDA, prior
to beginning human clinical trials.
The drug candidates tested in this safety/toxicology study have
previously shown broad-spectrum effectiveness against
alphaherpesviruses, i.e. HSV-1, HSV-2, and VZV.
These candidates are being developed for multiple indications in
the HerpeCide™ program. The overall market size for our targeted
indications is in tens of billions of dollars.
There were no adverse effects on the skin at the treatment
sites. Equally importantly, the results of the non-GLP safety and
toxicology study showed that there were no overall observable
systemic effects either. There were no observable direct effects on
the primary organ function whether the drug was administered to the
skin or administered systemically. This includes liver and kidney
function. This is important as the liver and kidneys are major
organs involved in drug toxicity.
These results are consistent with the positive findings in a
model of VZV (the shingles virus) infection of human skin in which
no safety or toxicology concerns have been observed, further
demonstrating the safety of these drug candidates. The drug
candidates have shown strong effectiveness in these shingles virus
studies as well, as previously reported. Further, these candidates
have demonstrated strong anti-viral activities against HSV-1,
HSV-2, and VZV in cell culture studies using multiple cell
lines.
Dermal topical treatment of rats with formulated drug candidates
was evaluated in this study as a primary objective, since skin is
the primary breakout site of HSV-1, HSV-2, and VZV infections.
Additionally, the same drug candidates as formulated for systemic
delivery were employed to evaluate potential systemic
safety/toxicological effects.
The Company's drug candidates in HerpeCide™ program are being
developed for direct topical application on the affected areas to
control the infections. Direct topical application enables delivery
of the highest possible concentrations of the active substance
directly at the site of infection. This allows for maximal clinical
effectiveness, while at the same time minimizing side effects that
are seen with systemic therapy (such as oral drugs or
injectables).
The Company expects to report additional data on the effects on
the tissue structure (i.e. histopathology) when available. The
study was conducted by AR Biosystems of Beverly, MA.
Anil R. Diwan, PhD, President of the Company, will present these
data and the current state of development of the Company at the
2018 MicroCap Conference in New York
City today. His presentation is scheduled for 10am today in Track 1. The Microcap Conference is
being held at the Essex House in New York
City (https://microcapconf.com).
About NanoViricides:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage
company that is creating special purpose nanomaterials for viral
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
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.