SHELTON, Conn., Aug. 7, 2018 /PRNewswire/ -- NanoViricides,
Inc. (NYSE Amer: NNVC) (the "Company")
reports that its anti-Shingles drug candidates were effective in
ameliorating pain sensations in an animal model of abnormal
pain. A characteristic excruciating pain is a debilitating
pathology of shingles presentation. Thus a direct pain-reducing
effect of the Company's anti-shingles drug candidates would be very
important in ameliorating the pathology of shingles, in addition to
the already demonstrated significant antiviral effect.
More importantly, the characteristic pins-and-needles pain in
shingles can persist in some patients even after the shingles
dermal presentation has resolved, for six months or longer. This is
called "post-herpetic neuralgia (PHN)" and is a debilitating
complication of shingles.
A highly effective treatment of shingles that would result in
reduction in the duration and severity of PHN cases has been
estimated to have a potential market size in the range of billions
of dollars, even after the recent introduction of the new
Shingrix vaccine. Approximately 18% of patients overall, and as
many as 30-50% of older patients with shingles, are estimated to
have PHN. This represents more than 200,000 cases of PHN annually
in the USA alone. Such VZV
complications can cause extended hospitalization in about 4% of
shingles patients overall, with an average estimated cost as high
as $20,000 per hospitalized
patient.
Shingles is caused by reactivation of the Varicella Zoster Virus
(VZV, aka human herpesvirus-3 or HHV-3). A chickenpox (i.e.
varicella) infection in childhood leads to the virus becoming
latent in the nervous system. At an older age, or when immunity
against this resident latent virus decreases, the virus replicates
in the nerve cells, and bursts out of the nerve endings infecting
neighboring skin cells, thus causing a typical shingles rash. The
nerve injury caused by the virus leads to a characteristic
excruciating and debilitating pain. The shingles rash may continue
to expand for several days, and then subsides in about three weeks
in an uncomplicated case. The VZV-associated neuropathic pain does
not resolve quickly, and may continue even after the rash has
resolved (hence called PHN), for several months to, in rare cases,
years.
Nerve injury of the peripheral sensory system due to trauma or
disease sometimes produces abnormal (neuropathic) pain. This
type of nerve injury and abnormal pain sensations are often
observed in patients with shingles caused by reactivation of the
varicella zoster virus (VZV) as well as in other diseases caused by
herpes virus infections.
In the current animal study, topical treatment with the
nanoviricides® anti-VZV compounds significantly reduced the
measures of abnormal pain sensations in a rat model of neuropathic
pain. The study was conducted at AR Biosystems in Tampa FL.
This effect is important for human neuropathic pain and for PHN.
Firstly, this effect indicates that the Company's anti-shingles
drug candidate could ameliorate the shingles-associated pain. This
is a highly sought-after characteristic for an anti-shingles drug.
Secondly, it could reduce the severity of PHN, and the drug could
be used even after the rash has subsided to minimize the residual
PHN. This could lead to a reduction in the need for
traditional pain killers, which is an important benefit.
These results complement the positive findings in a model of VZV
(the shingles virus) infection of human skin in which its shingles
virus drug candidates demonstrated highly effective anti-VZV
activity. In addition, no safety or toxicology concerns have been
observed in a preliminary safety/toxicology animal study.
The results of this study and other pre-clinical studies of
virus infection will provide the basis for selection of a final
drug development candidate.
The Company is now planning IND-enabling safety/toxicology
studies. In addition, the Company is also scaling up its production
capabilities for these drug candidates, to support the ensuing
safety/toxicology studies and initial human clinical trials.
Currently there is no effective therapy for shingles or for PHN.
While acyclovir derivatives may be prescribed for shingles,
acyclovir does not have a significant antiviral effect against VZV.
PHN is treated with escalating levels of traditional pain
medications, beginning with NSAIDs, and progressing to
morphine-class of drugs depending upon severity and length of the
episode. An older shingles vaccine is not very effective in
protecting older patients. However, a new vaccine, Shingrix™, was
introduced recently that is expected to be very effective. In spite
of these vaccines, a drug for the treatment of VZV-shingles remains
a sought-after unmet medical need, and presents a potential
multi-billion dollar market.
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.