WEST HAVEN, Conn., Jan. 23, 2015 /PRNewswire/ -- NanoViricides,
Inc. (NYSE MKT: NNVC) (the "Company"), a nanomedicine company
developing anti-viral drugs, reported a good safety profile of an
optimized FluCide® drug candidate in a GLP-like toxicology study in
rats. These results are extremely important since they indicate
that FluCide continues to look very promising as one of the most
advanced candidates in the Company's drug development pipeline.
No direct adverse clinical effects were found upon
administration of the FluCide candidate intravenously at doses of
up to 300mg/kg/day for 14 days (a total of 4,200mg/kg) in rats.
Organs were examined for gross histological observations.
Microscopic histological tissue analysis was also performed. There
were no adverse histological findings in gross organ level
histological examination, nor were there any adverse findings in
microscopic histological analysis. Equally importantly, there were
no meaningful effects observed on animal weight gain, food
consumption, hematology, or clinical chemistry at the end of the 14
day dosing period.
The study was conducted at BASi (Bioanalytical Systems, Inc.,
NASDAQ: BASI) in Evansville,
Indiana. The study was performed in a cGLP-like fashion,
compliant with BASi Evansville standard operating procedures. BASi
has over 40 years of experience providing contract research
services and niche instrumentation to the life sciences, primarily
drug research and development.
These results are in agreement with the previously reported
results of a non-GLP toxicology study in mice. The current study
results also support the Company's positive findings in animal
models of infection with different influenza A virus strains in
which no safety or toxicology concerns were observed. The
Company has previously reported that many of its FluCide candidates
demonstrated extremely high anti-influenza activity in those
models.
This study was developed in collaboration with BASi and
conducted by BASi in a cGLP-like fashion in order to understand the
safety parameters of FluCide intravenous dosing.
The next phase of the toxicology package studies will involve
larger animals, and will require much larger quantities of the drug
candidate. The Company is in the process of commissioning
operations at the new 1 Controls Drive, Shelton, CT facility in order to perform the
scale up studies needed for making the large quantities of
materials in a controlled manner. These upcoming studies will be
performed in cGLP compliant manner to provide safety and toxicology
data that are required for an IND submission to regulatory
agencies.
About NanoViricides:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage
company that is creating special purpose nanomaterials for
antiviral 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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SOURCE NanoViricides, Inc.