Dengue Fever Case in New York Highlights Importance of NanoViricides’ DengueCide® Development Program
November 21 2013 - 2:37PM
Business Wire
(NYSE:NNVC) CBS reported yesterday that New York State has seen
its first case of dengue fever acquired locally
(http://newyork.cbslocal.com/2013/11/20/new-york-states-first-known-dengue-virus-infection-found-on-long-island/).
With cases in Florida, Texas and now in New York, in addition to
25,000 suspected cases reported in Puerto Rico this past summer,
dengue virus is clearly becoming an important pathogen of concern
in the United States.
NanoViricides, Inc. believes that it is a leading company in the
fight against dengue. Our DengueCide™ drug candidate has been
awarded orphan drug status by the U.S. Food and Drug Administration
(FDA) as well as the European Medicines Agency (EMA), covering the
USA and all the 27 countries within the European Union. This drug
candidate has shown unprecedented effectiveness in a special mouse
model that simulates secondary dengue/dengue hemorrhagic fever.
“We believe that DengueCide is going to be a very important drug
to treat dengue,” said Eugene Seymour, MD, MPH, Chief Executive
Officer of the Company, adding, “This recent case of dengue
infection locally in New York illustrates that the Aedes Aegypti
mosquito carrying dengue virus has reached further north than
generally believed. This vector mosquito is already reported to be
found in California as well. With this mosquito spreading, there is
concern that more cases would be reported in other parts of the USA
as well over the next few years.”
“DengueCide’s effectiveness in mouse model is expected to
readily translate to humans,” said Anil R. Diwan, PhD, President of
the Company, adding, ”This is because nanoviricides are designed to
directly attack the virus particles in circulation, independently
of the host.”
The FDA and EMA orphan drug designations cover approximately 750
million people worldwide. These designations will provide a number
of significant benefits to NanoViricides as DengueCide eventually
moves through the regulatory approval process. These benefits
include tax considerations, priority review and a significant
extension in patent coverage, among others. The additional patent
coverage may be as long as 10 years in the EU. In addition, the
Priority Review Voucher (PRV) program of the US FDA specifically
includes dengue and dengue hemorrhagic fever.. A PRV can be awarded
upon approval of a treatment for dengue. The PRV can then be used
by the awardee to accelerate review of another drug in human trials
or it can be sold for a consideration.
The Company also recently announced renewal of its testing
agreement for DengueCide and next generation dengue therapeutics
with the Dr. Eva Harris Laboratory at the University of California,
Berkeley.
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.
NanoViricides, Inc.Amanda Schuon,
310-550-7200info@nanoviricides.com
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