|[December 02, 2013]
NanoViricides, Inc. Reports Excellent Safety Profile of Its Broad-Spectrum anti-Influenza Drug Candidate, FluCide™ , in a Non-GLP Study
WEST HAVEN, Conn. --(Business Wire)--
NanoViricides, Inc. (NYSE MKT:NNVC)
(the "Company") reports that it has received results of detailed lab
analysis studies from the initial non-GLP toxicology studies of
intravenously administered FluCide™. No overt adverse safety and
toxicology effects were observed in this study of the Company's
optimized FluCide broad-spectrum anti-influenza drug candidate, even at
the maximum feasible dose level. These results are consistent with the
preliminary findings of this study that the Company has previously
reported, and provide greater details of the safety of FluCide.
Detailed laboratory analyses of samples from this non-GLP safety and
toxicology study showed no overall systemic effects and no direct
effects on the primary organs. This includes liver and kidney tissues as
well as liver and kidney function. This is important as the liver and
kidneys are major organs involved in drug toxicity. In addition, FluCide
showed no adverse effects on the lungs from the treated animals. This is
very important because the respiratory system is a primary site of
influenza virus infection and tissue damage. These strong safety
findings were seen at all doses tested, even at the maximum feasible
dose (MFD). MFD was much higher than the therapeutic dose range used to
treat influenza virus infections in our animal model efficacy studies.
FluCide was administered intravenously by tail-vein injections or by
infusion in this study. The non-GLP safety/toxicology study was
conducted at KARD Scientific in Massachusetts.
These results support the Company's positive findings in animals that
were infected with different influenza A virus strains. In those
studies, no safety or toxicology concerns were observed.�The Company has
previously reported that its FluCide candidate demonstrated extremely
high anti-influenza activity in lethal infection animal models using
multiple influenza A subtypes.�The extremely high anti-influenza
activity coupled with the strong safety data were the basis for the
selection of this FluCide candidate for further drug development.
As previously reported, the results of this study will provide both the
basis and focus for the GLP safety and toxicology studies of FluCide
that are required for the IND submission to the U.S. FDA. These GLP
studies will be performed on both large and small animals at the BASi
facility in Indiana.
A critical step in FluCide drug development is he ability to produce
clinical scale drug product. The Company has previously reported that
the renovation of its facility in Shelton, CT, for its new clinical
scale production plant is in the construction phase with projected
completion during Q1 2014. The Company is performing certain scale up
studies for manufacturing FluCide at its current facility.
The Company is considering two separate indications for this injectable
FluCide drug. The first is hospitalized patients with severe influenza.
Current influenza treatments have limited effectiveness in this setting
because of the severity of the infection. 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 likely increase those numbers by an order of
magnitude. The second planned indication for injectable FluCide would be
for out-patients with influenza. During the 2009 H1N1 "swine flu"
pandemic, there were approximately 61 million cases of out-patient
influenza in the USA alone.
The market size for anti-influenza drugs is currently estimated to be in
the billions of dollars worldwide. The Company believes that if its
FluCide® drug becomes available, the influenza drug market size could
become substantially larger. Historically, it is well known that when a
highly effective therapeutic becomes available, the market size for the
underlying indication expands dramatically.
The Company is also continuing the development of its oral FluCide drug
candidate that is expected to follow the injectable FluCide into
clinical development. We believe that the oral FluCide also would be
found to be extremely safe, based on the excellent safety of the
injectable FluCide drug candidate as demonstrated by this non-GLP study.
Orally bioavailable FluCide is expected to significantly expand the
market size for our anti-influenza program.
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.
[ InfoTech Spotlight's Homepage ]