SHELTON, Conn., April 6, 2015 /PRNewswire/ -- NanoViricides,
Inc. (NYSE MKT: NNVC) (the "Company"), a nanomedicine company
developing anti-viral drugs, reports on the Company's progress in
the recent quarter.
Ebola
Using NanoViricides's rapid design platform, it
took only 4 months from design to synthesis of the multiple
EbolaCide drug candidates needed for study. In late January, these
novel anti-Ebola drug candidates were sent to our collaborating
BSL-4 facility for initial testing. Our drug candidates were found
to be broad-spectrum, in that they were equally effective against
Ebola virus as well as Marburg viruses. This is unlike the
antibody-based, siRNA-based and antisense-based anti-Ebola
therapeutics currently being advanced, which only work against
specific strains with a very narrow and selective spectrum of
activity. Broad-spectrum activity of our drug candidates is a very
important and valuable characteristic, as it indicates that
mutations of the virus in the field are unlikely to cause escape of
the virus from our final EbolaCide™ drug. We believe that with the
new insight we have gained, and with our experience from earlier
studies, we can continue to optimize our multiple drug candidates
before another Ebola epidemic strikes. The recent outbreak in
Africa, though now waning, has
unequivocally demonstrated the need for an effective,
broad-spectrum, anti-Ebola therapeutic in order to control any
further outbreaks.
Herpes
The Company has also been working on its
anti-herpes drug candidates. Our anti-HSV (herpes simplex virus)
drug candidates have previously shown strong activity with
>99.9% inhibition when tested against two significantly
different strains of HSV-1 in cell culture studies. The anti-HSV
drug candidates have since been further modified to improve
effectiveness in dermal application in a small animal dermal HSV-1
infection model. The cell culture and animal studies have been
completed as of today and we are now awaiting the reports. These
studies were performed in Professor Ken
Rosenthal's laboratory at the Northeast Ohio Medical
University.
We anticipate that these broad-spectrum anti-HSV drug candidates
would be effective against oral and skin lesions caused by HSV-1
strains, genital lesions caused by HSV-2 strains, herpes keratitis
(a potentially blinding eye disease caused by HSV-1), and most
probably against shingles as well. Shingles or zoster is a
wide-spread skin disease that occurs from re-awakening of the
chickenpox virus (namely, human herpesvirus-3 aka varicella zoster
virus). VZV, like HSV-1 and HSV-2 is in the alpha-herpesvirus
family. There are one million cases of shingles in the US yearly.
There are approximately 25 million cases of genital herpes in the
US on an annual basis.
Influenza
We are currently working to increase the
production of FluCide™, our anti-influenza drug candidate. FluCide
has been designed for use in hospitalized patients with complicated
influenza. FluCide was found to be extremely safe in preliminary
toxicology studies in mice and rats. As a result of the extreme
safety finding, it was estimated that about 2.5kg of drug substance
would be needed for the complete large animal toxicology studies.
These studies are needed for filing an Investigational New
Drug Application (IND). In mice, no adverse events were observed
even at doses as high as 480 mg/kg/d repeated on five days (a total
of 2,400 mg/kg), when given intraperitoneally. Similar strong
safety was also observed in the initial part of the formal
toxicology study in rats. In rats, no adverse events were observed
with doses as high as 300mg/kg/d given by rapid intravenous
infusion, and repeated for 14 days (a total of 4,200 mg/kg). We are
in the process of producing a total of 2.5kg of FluCide for the
final large animal toxicology studies. Our toxicology studies are
being performed by BioAnalytical Systems, Inc. (BASI) of
Indiana (NASDAQ: BASI).
We are now working to optimize all of the processes involved in
the production of FluCide. Equipment needed for this task is being
acquired, and is being installed by factory representatives as it
arrives. Some items have lead times of 6 to 8 weeks for delivery.
We are working as quickly as possible on setting up the production
processes at our new state of the art c-GMP-capable manufacturing
facility in Shelton, CT.
We are happy to announce that our Biological Characterization
Group has now completely moved to our Shelton, CT campus. We are implementing a
phased move to Shelton so that
there is minimal impact on our continuing operations. We plan on
continuing to use our West Haven
facility to maximize R&D efforts on our large number of drug
development programs.
Drug Pipeline
The Company has six commercially
important drug development programs in its rich pipeline. These
include (i) Injectable FluCide for hospitalized patients, (ii) Oral
FluCide™ for out-patients with Influenza, (iii) broad spectrum
HerpeCide™ for various forms of herpes virus infections that cause
oral and genital herpes, herpes keratitis (eye disease), and
possibly also chickenpox, and shingles, (iv) a broad-spectrum
antiviral ophthalmic solution for viral diseases of the eye such as
epidemic kerato-conjunctivitis (EKC, caused usually by
adenoviruses), and herpes keratitis, (v) DengueCide™, a
broad-spectrum drug against all four types of dengue viruses, and
(vi) HIVCide™, a broad-spectrum anti-HIV drug candidate that may be
a "functional cure" against HIV/AIDS. In addition, we are engaged
in research programs for the development of broad-spectrum drug
candidates against a number of other viruses. These include
filoviruses such as Ebola and Marburg, Rabies, and many others. We
continue to advance these programs as opportunities become
available. In the past, we have been constrained by the limitation
of our small laboratory R&D facility in West Haven, CT. We now have a 18,000 sq. ft.
state of the art cGMP-capable manufacturing facility for clinical
scale production of any of our nanomedicine dug candidates
including injectables, located in Shelton, CT. We are now working to bring the
facility into full-scale operation. We anticipate that this
facility will dramatically expand our ability to move our drug
candidates into a clinical stage pipeline.
The Company has previously announced that it had approximately
$36.4 Million (M) of current assets
plus restricted cash (cash, cash equivalents, collateral advance,
prepaid expenses, and security deposits) as of December 31, 2014. The Company's operating
expenditure is approximately $2M per
quarter. We believe that we have sufficient funding available to
perform initial human clinical studies on at least one of our drug
candidates, and possibly to bring at least one other drug candidate
into IND stage.
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.