SHELTON, Conn., Mar. 5, 2019 /PRNewswire/ -- NanoViricides,
Inc. (NYSE MKT: NNVC) (the "Company") a company with novel platform
technology to treat difficult and life-threatening viral diseases,
announces that its first drug candidate has successfully completed
the first of the Safety/Toxicology studies moving towards human
clinical trials.
The Company is developing its broad-spectrum drug candidate in
the HerpeCide™ program, namely, "NV-HHV-101," towards human clinical trials.
The drug candidate is formulated as a dermal topical cream.The
first part of the IND-enabling safety/toxicology studies comprised
a non-GLP evaluation of safety and tolerability of the drug
candidate in mini-pigs. The study was performed by BASi,
Evansville, IN, an independent
contract research organization that is specialized in IND-enabling
safety/toxicology studies.
In this study, all dosage levels of the nanoviricide® drug
product, including the maximum feasible dose, were well tolerated
in all treated animals. All of the parameters evaluated in the
study remained within normal ranges, and showed no adverse effects
from the drug treatment.
These strong safety results are consistent with our previous
studies on two related drug candidates during drug candidate
optimization. The Company has previously tested two related
development candidates in the HerpeCide™ program in non-GLP Safety
and Tolerability study in rats for dermal exposure as well as
systemic exposure by subcutaneous and intravenous routes of
administration. The Company previously reported that those
candidates were both found to be safe based on multiple parameters
in the completed non-GLP Tolerability study.
Mini-pigs are considered to be a well correlated animal model
for human dermal drug and cosmetics development. Pigs and mini-pigs
are a much closer correlate of human clinical results as compared
to rats for dermal topical applications.
The success of these studies forms the basis for progressing the
drug candidate into more formal GLP Safety/Toxicology studies. The
Company is negotiating with BASi for the earliest possible date for
starting the GLP phase of these IND-enabling studies. Assuming that
the GLP studies are also successful, the Company anticipates
advancing NV-HHV-101 into human clinical trials for topical dermal
treatment of the shingles rash as the initial indication.
In this non-GLP study, the drug skin cream was applied topically
twice daily to approximately 10% of the total body surface area of
each mini-pig in the group for seven days, as per a standard
protocol for regulatory agencies including the US FDA. Each group
of animals received a single dosage level (i.e. a given
concentration of the API in the same amount of formulation
vehicle). The dosage levels were varied from zero (vehicle alone)
up to the maximum feasible dose in the study employing multiple
groups.
The animals were evaluated daily for general signs of adverse
effects and toxicity including body weight, detailed clinical
physical observations as well as the specific evaluation of the
skin treatment areas. Prior to treatment and one day after
completion of dosing, blood samples were taken from each animal for
hematology and clinical chemistry standard testing to assess
systemic adverse effects, if any.
The seven days of treatment in this study began towards the end
of December 2018, as previously
reported by the Company.
Minipig size, anatomy, physiology, metabolism, and genetics are
considered to correlate well to those of humans. Pig skin is
anatomically, physiologically, biochemically, and immunologically
similar to human skin. Also, pig skin is fixed or adherent like
humans unlike the loose skin of rodents and dogs that are typically
used in other safety and tolerability studies. The outer skin
layer, the epidermis, of the minipig is also approximately the same
thickness as that of human skin. Thus, minipigs are preferred by
regulatory agencies for dermal treatment safety and tolerability
studies.
The Company also continues to evaluate this broad-spectrum drug
candidate as well as certain variations based on the same
candidate, for the treatment of other herpesviruses, namely HSV-1
cold sores and HSV-2 genital herpes. The market size for our
immediate target drugs in the HerpeCide™ program is variously
estimated into billions to tens of billions of dollars. The Company
believes that its dermal topical cream for the treatment of
shingles rash will be its first drug heading into clinical trials.
The Company believes that additional topical treatment candidates
in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment,
and HSV-2 "genital ulcers" treatment are expected to follow the
shingles candidate into IND-enabling development and then into
human clinical trials.
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
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. "API" means
active pharmaceutical ingredient.
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SOURCE NanoViricides, Inc.