|[February 11, 2013]
NanoViricides to Present at the 15th Annual BIO-CEO Conference in NYC Tomorrow
WEST HAVEN, Conn. --(Business Wire)--
NanoViricides, Inc. (OTC BB: NNVC)
(the "Company") announced today that its President, Dr. Anil Diwan, will
present an overview of the company at the 15th
Annual BIO CEO and Investor Conference. The Conference is being held
at the Waldorf-Astoria Hotel in New York City (http://www.bio.org/events/conferences/15th-annual-bio-ceo-investor-conference).
NanoViricides, Inc. presentation is scheduled for 11:30 am EST tomorrow,
February 12th, in the Conrad Room.
The first ever orally active nanomedicine has been developed by
NanoViricides, Inc. This oral anti-influenza drug candidate has shown
very high bioavailability. NanoViricides also has an injectable
anti-influenza drug in development towards clinical studies for serious
cases of influenza. A pre-IND meeting with the FDA has helped the
Company build its FluCide™ anti-influenza therapeutics program towards
human clinical trials. Both the oral and injectable anti-influenza drug
candidates have shown significant superiority over oseltamivir
(Tamiflu®) in highly lethal animal model studies. Both drug candidates
have shown strong activity against multiple, unrelated influenza types,
suggesting that they indeed have broad-spectrum effectiveness against
most if not all influenza viruses.
NanoViricides has also shown that its drug candidates against HIV/AIDS,
even while being used as a single agent, had effectiveness equivalent to
a triple drug HAART cocktail therapy in the standard humanized SCID-hu
Thy/Liv mouse model. Further, viral load suppression continued, even
after the nanoviricide drug treatment was stopped, for at least 4 weeks
from last dosage, in contrast to current drugs which require daily
therapy. This mouse model possesses human lymphocytes and results from
this model are known to correlate well with human clinical studies. The
Company believes that its HIVCide™ drug candidate will provide a
"Functional Cure" of HIV/AIDS. A functional cure means that all anti-HIV
and related medications can be discontinued until a new resurgence of
the virus results from awakening of some latent reservoirs, which can
take several months to several years.
NanoViricides has recently announced that it has raised $6M from private
long-term investors (family offices) and a charitable foundation,
resulting in approximately $19M cash in hand. The Company estimates that
it has sufficient cash available to be able to conduct initial human
clinical trials for its anti-influenza drug candidate.
NanoViricides is close to completing the design phase for its cGMP
clinical trials drug substance production facility in Connecticut. The
Clean Room suite for the production of clinical drug substance is being
designed, fabricated, and installed by AES Clean Technology, Inc. As
previously announced, privately held Inno-Haven, LLC, founded by Dr.
Diwan, who is also the Company's President and Chairman, has purchased
an 18,000 sq. ft. building on approximately 4.3 acres in September 2011
with funding raised privately. The capital costs of the building and
construction project are also being borne by Inno-Haven, LLC with
funding from private sources that include loan arrangements. In order to
minimize the capital costs, NanoViricides, Inc. intends to lease the
completed facilitie. A memorandum of understanding to that effect was
signed today and requires a lease agreement to be signed before March
31, 2013. The renovation project is estimated to be completed in
October, 2013, followed by occupancy and certifications by early 2014.
The Company is developing a broad range of anti-viral therapeutics
against a number of different viruses. This is enabled by its novel
nanoviricides® platform technology. A nanoviricide is designed to look
like the cell surface to the virus, complete with the "landing sites"
that the virus seeks on the cell surface to bind to the cell and
thereafter enter the cell. These "landing sites" are designed into the
nanoviricide by chemically incorporating "ligands" to which the virus is
expected to bind. The Company strives to develop ligands that closely
mimic the native landing sites of the virus, using in-silico modeling or
"molecular docking" studies. Even as a virus mutates constantly, these
landing sites to which the virus binds remain the same. The Company
therefore believes that its drugs would be effective against a large
range of strains and mutations of a given virus.
In addition to Influenza and HIV, the Company has developed drug
candidates against Dengue and Adenoviral Epidemic Kerato-Conjunctivitis
(EKC) that have all shown extremely high efficacies in pre-clinical
animal studies. The Company has also developed drug candidates against
Herpes that have shown strong efficacies in pre-clinical studies. These
additional four commercially important programs are at pre-clinical
candidate optimization stage. The Company has several R&D programs
against many other viruses including Ebola/Marburg and Rabies viruses.
The Company thus has a broad drug pipeline, enabled by its novel,
first-in-class, platform technology.
The Company is planning on two separate drugs against influenza: The
injectable NV-INF-1, a high strength dosage form, for hospitalized
patients with severe influenza; and the oral NV-INF-2, for out-patients
with less severe influenza. Both drug candidates should be able to be
used prophylactically to protect health care personnel and family
members at high risk of contracting the virus.
NV-INF-1 promises to be a highly effective anti-influenza drug, based on
the extremely high efficacy observed in animal studies, and the Company
believes that it would receive rapid and widespread acceptance for the
treatment of hospitalized patients with severe influenza. NV-INF-1 can
also be used for out-patient treatment in a medical office, as well as
for prophylactic treatment, and a single treatment is expected to be
effective in such less severe cases of influenza.
A single course treatment for out-patients is a highly sought after goal
in influenza therapeutics. During the 2009 H1N1 "swine flu" pandemic,
approximately 61 million cases of out-patient influenza were estimated
in the USA alone.
The Company's anti-influenza clinical drug candidate is expected to be
effective against a majority of strains and types of influenzas
including novel epidemic influenza strains such as the one encountered
in 2009-2010 (so called "swine flu"); seasonal flu such as H1N1, H3N2;
highly pathogenic types such as H7N and H9N; as well as the highly
lethal type, so called "bird flu" or H5N1. All influenza viruses use the
same common receptor to bind to human cells. Therefore the Company
believes that its influenza drug candidate should work against most of
the influenza viruses.
The Company is also developing an oral anti-influenza drug, NV-INF-2,
that is expected to become the drug of choice against influenza when it
becomes available, opening up a large world-wide market with billions of
cases per year.
In the USA alone, there are approximately 300,000 severe influenza cases
that require hospitalization every year resulting in approximately
40,000 deaths. Expert physician advice suggests that the dosage form
should be a high strength solution suitable for "piggy-back"
incorporation into the standard IV fluid supplement system that is
commonly used in hospitalized patients. Since current influenza
treatments have limited effectiveness in these patients because of the
severity of the infection and the stage of progression, there is a
significant unmet medical need for the treatment of hospitalized
influenza patients, which include immunocompromised patients.
The market size for anti-influenza drugs is currently estimated to be
approximately $4-$7 billion worldwide. The Company believes that if its
FluCide™ drugs become available, the influenza drug market size could
The Company is thus well poised for moving forward towards clinical
studies of its anti-influenza drugs. The other drugs are expected to
follow on as they progress further. The Company estimates that it is
targeting a market size of over $40 Billion worldwide with its rich drug
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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