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| [November 13, 2012] |
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NanoViricides Signs Agreement with BASi for Toxicology and Safety Studies
WEST HAVEN, Conn. --(Business Wire)--
NanoViricides, Inc. (OTCBB: NNVC)
(the "Company") announced today that it has entered into an agreement
with Bioanalytical Systems, Inc. (NASDAQ: BASI)
to conduct drug development studies required for submission of
Investigational New Drug (IND) applications to the FDA for its
nanoviricides® drug candidates against various viral diseases.
The Company has designed the toxicology and safety pharmacology studies
that will enable the IND submission and the first-in-human clinical
trials of its FluCide® investigational anti-influenza product. BASi will
conduct the cGLP and non-GLP studies as required (cGLP = current Good
Laboratory Practices). These studies are designed to assess overall
safety in animals receiving multiple doses of FluCide. Specific safety
pharmacology studies will also be conducted to assess the effects of
FluCide® on the cardiovascular, respiratory and central nervous systems.
These studies are required for US FDA IND submission, as well as for
applications to conduct human clinical trials in other countries such as
Australia.
The design of the studies was reviewed by the FDA in a pre-IND meeting,
as previously announced by the Company.
The Company has previously reported successful results of the Company's
FluCide™ drug candidates in pre-clinical animal studies using two
different phylogenetically distinct types of Influenza A, viz. H1N1 and
H3N2. The Company has also reported that the drug candidates have been
found to be extremely safe in these animal studies. The Company intends
to conduct additional efficacy studies as required for the IND
application in parallel with the safety/toxicology studies.
The Company anticipates that it will need very large quantities of the
drug candidate for these "tox package" studies. The Company has found
FluCide to be safe in nimals at large dosages, and will need to
determine certain safety and toxicology limit parameters. The Company is
currently performing scale-up studies in order to produce the necessary
quantities of the drug candidate.
About
BASi:
BASi, established in 1974 with headquarters in West Lafayette, Indiana,
is a pharmaceutical development company providing contract research
services and monitoring instruments to the world's leading drug
development companies and medical research organizations. With over 30
years of experience, BASi conducts IND-enabling drug safety and
toxicology studies at its AAALAC-accredited laboratory located on a
52-acre campus near Evansville, Indiana. BASi has an excellent record of
regulatory compliance. All facilities have been inspected by the US FDA
with no significant adverse findings. Visit www.BASinc.com
for more about BASi.
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.

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