NanoViricides, Inc. (NYSE MKT:NNVC) (the “Company”) reports that
it has shipped FluCide™ to BASi for the start of toxicology
studies. NanoViricides has chosen BioAnalytical Systems Inc.
Toxicology Services (“BASi”) of West Lafayette, Indiana to perform
our safety/toxicology studies as needed for an IND submission of
the Injectable FluCide drug candidate.
In other news, NanoViricides reported that the synthesis of its
anti-Ebola second generation drug candidates has started. We
anticipate being able to evaluate these against Ebola virus with
certain of our previous collaborators. The contracts to enable such
evaluation are currently in progress. The Company’s nanomedicine
technology enables development of drugs that directly attack the
virus, in a manner that a virus may not be able to overcome despite
mutational changes. This is very important for the current
epidemic-causing Ebola virus strain, which has been shown to be
mutating rapidly.
Injectable FluCide was found to be extremely safe in mice in a
preliminary safety study. This study showed no evidence of any
adverse events even at the maximum tolerable dose level. No
significant changes in all observed parameters were found even at
the maximum feasible dose of approximately 2,700 mg/kg/d repeatedly
given for five consecutive days.
With this information, and in consultation with BASi, we
designed the safety/toxicology protocols for certain starting
studies. We estimated that the total “Tox Package” studies would
need as much as 2.5kg of the drug substance. Recently we broke up
the study into parts and developed a starting study protocol that
would require a 200g batch. Simultaneously, we have successfully
scaled up our synthesis processes in the current Wood Street
facilities, to be able to produce a 200g batch. The material we
produced has gone through certain tests for its quality. We then
prepared the samples as per the protocol design, and we have
shipped them to BASi yesterday.
Injectable FluCide is our first drug candidate, designed to
treat hospitalized patients with severe influenza. As noted above,
it has been found to be extremely safe. In addition, it was found
to be highly effective in combatting a highly lethal influenza A
virus infection in mice. It was found to be highly effective
against both Influenza A/H1N1 (same subtype as the 2009 pandemic),
as well as Influenza A/H3N2 (another pandemic/epidemic strain).
We have previously published the pre-clinical data on the
Company’s first drug candidate, NV-INF-1, Injectable FluCide™, to
treat all influenza infections in hospitalized patients. FluCide
has been built on the nanoviricides® technology platform. Influenza
A H1N1 infected animals treated with FluCide survived the full
21-day observation period, whereas animals treated with 40mg/kg/d
oseltamivir phosphate (Tamiflu®) survived only 8 days in this
highly lethal study. Influenza A/WS/33/ (H1N1) virus was used in
this study. The highly lethal infectious dose of 1M viral particles
at time 0 h followed by another 1M virus particles at 23h that was
employed caused uniform lethality in 5 days in untreated mice. Body
weight began to decline in the infected, untreated mice, by days
2-3 days and continued to decline until death. The
Oseltamivir-treated mice maintained body weight only through day 5,
which declined thereafter until death. Similar to the survival
results, the mice treated with NV-INF-1 maintained their body
weight substantially longer, through day 14. NV-INF-1 demonstrated
an unparalleled 1,000-fold reduction in lung viral load compared to
untreated animals on day 4 in this lethal animal model study.
Moreover, the lung viral load was suppressed to this baseline level
through 13 days or longer, with a slight increase on day 19. In
contrast, the current standard of care, oseltamivir, (Tamiflu®,
Roche) exhibited only a 2-fold reduction in lung viral load at day
4 that rapidly rose by approximately 2X on day 7. Similar to the
reduced virus titers, on day 4 the lungs from mice that were
treated with NV-INF-1 showed a substantially lower lung weight
(healthy) and displayed a markedly reduced presence of
virus-induced lesions as compared to the untreated control and
oseltamivir. Also similar to lung virus titers, the reductions in
lung lesions in animals treated with NV-INF-1 were maintained at
least through 13 days.
The data indicate that NV-INF-1 is a highly effective,
broad-spectrum, anti-influenza drugs. The Company has shown that
they are effective against both group I and group II influenza A
viruses.
The market size for an effective influenza drug for treating
severely ill hospitalized patients has been estimated in the
billions of dollars, worldwide, depending upon the therapeutic
value and cost savings. Currently, there is no effective
therapeutic available for this indication. The Company believes
that it could supply a substantial portion of the demand for this
drug from its new small-scale cGMP clinical drug manufacturing
facility.
This broad-spectrum FluCide drug is expected to work against
most, if not all, forms of influenza virus, including epidemic,
pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9,
and “bird flu” such as H5N1.
The total market size addressed by the Company’s current drug
programs is estimated at about $50 billion. In addition to
Injectable FluCide, the Company is working on five more
commercially important drug candidates, namely: DengueCide™,
HerpeCide™, HIVCide™, Oral FluCide™ for out-patients with
influenzas, and a broad-spectrum antiviral drug for viral diseases
of the external eye. All of our programs are for therapeutics to
treat viral infections. Our drugs are expected to be useful as
prophylactics as well. DengueCide has recently received orphan drug
designation by the US FDA as well as the European EMA.
The Company currently has approximately $48 million cash-in-hand
and cash-like-instruments. These funds are estimated to be
sufficient for taking at least one of our drug candidates through
initial human clinical trials, and possibly take another drug
candidate into human clinical trials.
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.
About BASi: (www.basinc.com)
BASi (Bioanalytical Systems, Inc.) established in 1974 has
headquarters in West Lafayette, Indiana. It provides contract
research services and niche instrumentation, serving the life
sciences industries, primarily in drug research and development.
BASi was founded by a Purdue University chemistry professor and a
group of his doctoral level students. Utilizing their abilities in
electrochemistry they developed a line of products to detect trace
chemicals in complex matrices. In the late 80’s, BASi entered the
services business utilizing liquid chromatography and mass
spectroscopy to provide analytical services to clients in their
drug discovery efforts. BASi became a public company in 1997.
Through a series of acquisitions in the 1990s and 2000s, BASi
entered the EU market with a location in England, the preclinical
toxicology market with a site near Evansville, Indiana for animal
models and veterinary market.
NanoViricides, Inc.Amanda Schuon, 310-550-7200info@nanoviricides.com
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