SHELTON, Conn., April
27, 2015 /PRNewswire/ -- NanoViricides, Inc., (NYSE MKT: NNVC)
(the "Company"), a nanomedicine company developing anti-viral
drugs, discusses the significance of the strong effectiveness
demonstrated by its anti-viral drug candidates in a lethal animal
model of dermal herpes infection.
NanoViricides, Inc. recently reported that its anti-Herpes drug
candidates demonstrated substantially complete survival of mice
that were lethally infected with the HSV-1 H129c strain. In
contrast, acyclovir, the standard of care drug, resulted in only a
limited survival (less than 58%), even though it was employed at
twice the human drug concentration. Further, the survival
improvement correlated with the reduction in clinical disease
scores, demonstrating significant reduction in disease
severity.
These results are very significant considering that topical
acyclovir in the form of a cream as well as an ointment are
approved for the treatment of cold sores.
Our strong anti-herpes nanoviricide® drug candidates are capable
of reaching approval as drug for topical use against herpes cold
sores, the Company believes, based on these datasets. Further drug
development is necessary towards the goal of drug approval.
The Company intends to meet with its FDA advisory consulting
group, namely, Biologics Consulting Group, Inc., to chart out the
path towards approval. In addition, the Company intends to engage a
Contract Research Organization (CRO) for further development of a
topical anti-herpes drug into the regulatory approval pathway for
US FDA as well as internationally.
"A rapid drug approval process is possible for our anti-herpes
nanoviricide® topical skin treatment," said Eugene Seymour, MD, MPH, "We intend to
investigate the regulatory pathway and intend to put our
anti-herpes drug candidates into the approval process as soon as
feasible."
"The pace of development of our broad drug pipeline is now
accelerating due to the strong financing we have been able to raise
concomitant with our up-listing to the NYSE-MKT exchange," said
Anil R. Diwan, PhD, President.
In another news, the Company reports that the process of
commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group
has already moved operations to the new facility. Large Scale
Chemistry Group is completing the necessary modifications to the
facility to enable large scale production processes. Various
laboratory instruments are being installed by vendors under
warranty programs for installation qualification and operational
qualification.
In just four cycles of further improvements undertaken since
2010, the Company has now reached its goal of substantially
complete survival in the highly lethal animal model of dermal
herpesvirus infection (HSV-1 H129c strain), wherein no current
drugs have shown substantial survival effect. Our anti-Herpes
program began in 2009, and soon thereafter, the Company
demonstrated strong anti-herpes efficacy in cell cultures against
two different HSV-1 strains at two different sites. Since then the
Company has been optimizing the drug candidates to achieve strong
effectiveness in a highly lethal animal model. Due to resource
constraints, the Company has been able to perform these studies
only sporadically. Since up-listing in late 2013 and raising
significant amounts of financing, the Company has been able to make
strong further progress against Herpes that has resulted in the
recent achievements.
The reported studies were performed in Professor Ken Rosenthal's laboratory at the
NorthEast Ohio Medical University (NEOMED). Professor
Rosenthal retired last year and continued as Professor Emeritus at
NEOMED. Even after his retirement, he continued his research, and
was personally involved in on-going studies of nanoviricides drug
candidates in his laboratory. Professor Rosenthal has now joined
Roseman University of Health Sciences, Las Vegas, Nevada, as a Professor of
Biomedical Sciences. He will continue as a consultant to
NanoViricides for our anti-herpes drug development program.
The nanoviricides® mechanism of action is believed to mimic a
natural host cell receptor using which the virus binds and infects
cells; binding of a nanoviricide nanomicelle to the virus is
expected to render it non-infectious. A nanoviricide would thus
stop the spread of the viral infection to new uninfected
cells. This mechanism is different from that of currently
available anti-Herpes drugs. The Company therefore believes that it
is able to develop broad-spectrum anti-herpes nanoviricide
drugs.
The market size for herpes simplex virus treatments is in excess
of $2 billion annually. The Company
estimates that an effective treatment could lead to a doubling in
the market size.
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.
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SOURCE NanoViricides, Inc.