SHELTON, Conn., June 20, 2016 /PRNewswire/ -- NanoViricides, Inc.
(NYSE MKT: NNVC) (the "Company"), a global leader in nanomedicines
that is developing biomimetic anti-viral drugs reports that its
herpesvirus drug development programs are progressing
satisfactorily.
The Company has previously said that in its HerpeCide™ program,
it is currently developing drugs against four different herpesviral
disease indications, namely, (i) "Cold sores" caused by Herpes
Simplex Virus-1 (HSV-1), (ii) Shingles caused by re-awakening of
the chickenpox virus (Varicella Zoster Virus, VZV), (iii) Ocular
herpes keratitis which is caused by HSV-1 or HSV-2, and (iv)
"Genital ulcers" caused by HSV-2. All of these drugs are
being developed as topical treatments.
The Company has previously identified a drug candidate that
demonstrated substantially complete protection to mice lethally
infected with HSV-1 H129 neurotropic strain that produces
zosteriform disease in the animals. while in the same study, only
58% of acyclovir treated mice survived. The study was repeated at a
different facility with similar results.
Since then the Company has undertaken further full fledged drug
candidate optimization program which is anticipated to result in a
candidates superior to the one in hand. As part of this program,
the Company has developed novel, broad-spectrum, herpesvirus
binding ligands using molecular modeling studies that exhibit
substantially better binding scores compared to the ligand employed
in the prior animal studies. Several of these ligands were
short-listed and were synthesized at small scale to enable cell
culture based antiviral evaluation against various
herpesviruses.
The Company has also developed different forms of the backbone
"nanomicelle" polymeric material to which we attach the antiviral
ligand to make the complete antiviral nanomedicine. These forms
have been designed to optimize uptake across the dermal barrier. A
few of these polymers have already been synthesized in quantities
sufficient to support animal studies of the HerpeCide candidates.
Importantly, the production processes are being optimized as they
are implemented. We believe that substantially optimizing these
processes at the scale we expect to require for human clinical
studies will save us time in making the clinical drug substance
batches.
Preliminary cell culture-based antiviral effectiveness and
toxicity testing is being undertaken at different facilities. A
further round of cell culture testing for more accurate, detailed
evaluation will be required before commissioning animal studies.
These evaluations are needed for reducing the large library of
candidates at the current drug candidate optimization stage to just
a few candidates going into pre-clinical animal
studies.
We are now in the process of making larger quantities of the
anti-herpesvirus ligands for making nanoviricides for the
pre-clinical animal testing programs to determine the best drug
candidate for each of the four drug indications described
above.
The Company has set up several antiviral cell culture based
assays in house, at our new Shelton campus, in our virology suites
certified at Biological Safety Level 2. In particular, the VZV
antiviral drug development assays have now been standardized. In
addition, HSV-1 and HSV-2 assay development work has been
commissioned. Additionally, anti-HSV cell culture testing is being
conducted at the Collaborative Ophthalmic Research Laboratories,
CORL, of the University of Wisconsin.
We also have collaborations with the University of Pittsburgh and the Baylor University for anti-HSV studies in eye
disease indications. We intend to perform animal studies against
the various herpesviruses in the relevant models for the four
different drug indications cited earlier, at these three facilities
as well as at TransPharm Preclinical Solutions, a contract
research organization.
"We are very happy with our progress in the four HerpeCide drug
development programs, and especially in the VZV program," said
Eugene Seymour, MD, MPH, CEO of the
Company, adding, "We are working as hard as we can and as fast as
we can to get at least one, and possibly more than one, of these
programs into human clinical trials in a relatively short
timeframe. However, we cannot provide timelines because of the
extreme dependence on external testing of our drug candidates and
the related inefficiencies."
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 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.
Logo - http://photos.prnewswire.com/prnh/20150107/167444LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/nanoviricides-reports-on-progress-of-its-drug-candidates-against-herpesviruses-300286916.html
SOURCE NanoViricides, Inc.