NanoViricides Announces Initiation of Toxicology Study of FluCide®
October 07 2013 - 7:00AM
Business Wire
NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company") reports that
it has initiated the initial non-GLP toxicology evaluation of its
optimized injectable FluCide® drug candidate. This study is an
important step in the drug development pathway for FluCide. The
Company previously had a pre-IND meeting with the U.S. FDA to
discuss and receive guidance on the FluCide drug development
pathway.
The non-GLP safety and toxicology study was begun in late
September at KARD Scientific in Massachusetts. The results of this
study will provide the basis and focus for the IND-enabling GLP
safety and toxicology studies of FluCide that are required for the
IND submission to the U.S. FDA. These IND-enabling GLP safety and
toxicology studies will be performed by BASi Toxicology Services in
West Lafayette, IN. The Company has previously reported that its
FluCide candidate was highly effective in animal models of
different influenza A virus strains. In those efficacy studies of
FluCide, no safety or toxicology concerns were observed. As a
result, the required quantity estimated for GLP safety/tox study is
much larger than our current synthesis capability. The Company has
undertaken process development, scale-up, chemistry optimization
and control program to enable large scale synthesis of FluCide in a
reproducible manner. This work is currently in progress.
The Company is considering two separate indications for this
injectable FluCide drug. The first is hospitalized patients with
severe influenza. In the USA, there are approximately 300,000
severe influenza cases that require hospitalization every year
resulting in approximately 40,000 to 50,000 deaths. A pandemic
would increase those numbers by an order of magnitude.
There is a well known unmet medical need for treatment of these
hospitalized patients as current influenza treatments have limited
effectiveness because of the severity of the infection. A highly
effective drug should receive rapid widespread acceptance.
The second planned indication would be for outpatients with
influenza. The Company is hopeful that the outpatient treatment
will likely be a single, small injection, at the first clinical
visit with no follow-on treatment needed. During the 2009 H1N1
“swine flu” pandemic, there were approximately 61 million cases of
out-patient influenza in the USA alone. A single course treatment
for out-patients is a highly sought after goal in influenza
therapeutics.
The Company is also developing an oral version of FluCide. The
oral FluCide development will follow and benefit from the
development of injectable FluCide. When approved, the oral FluCide
would replace the injection of FluCide in out-patient cases.
The market size for anti-influenza drugs is currently estimated
to be in several billions of dollars worldwide. The Company
believes that if its FluCide® drug becomes available, the influenza
drug market size could become substantially higher. The market size
for over the counter (OTC) medications for control of influenza
symptoms alone is approximately $2.1 billion dollars annually in
the USA, and about £0.5 billion (about $1 billion) in the UK
(source:
http://www.mintel.com/press-centre/press-releases/410/consumers-cough-up-for-remedies-as-flu-season-starts-early).
Similar large market sizes are reported for other countries across
the globe. It is well known that when an effective treatment for a
disease becomes available, the market size explodes and the novel
effective treatment captures a substantial portion of the
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.
NanoViricides, Inc.Amanda Schuon,
310-550-7200info@nanoviricides.com
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