NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company"), announced
today that a fundamental PCT patent application, on which the
nanoviricides® technology is based, has resulted in additional
issued patents in Australia and the Philippines.
“The issuance of the Australian patent is of particular
importance because of the Company’s interest in pursuing the
initial human clinical trials in that country,” said Eugene
Seymour, MD, MPH, CEO of the Company, adding, “Australia offers
significant advantages including financial incentives that would
help us speed the development of our drugs towards licensure.”
The Australian and Philippine patents have been allowed with a
very broad range of claims to a large number of families of
chemical structure compositions, pharmaceutical compositions,
methods of making the same, and uses of the same.
NanoViricides, Inc. holds exclusive, perpetual, worldwide
licenses to these technologies for a broad range of antiviral
applications and diseases (see below).
“It is rewarding to see that both the Australian and Philippine
patent offices recognized the novelty and the broad utility of the
entire ‘pi-polymer’ class of materials as defined by the inventors,
and granted a patent with sufficient scope to protect the whole of
the invention, for all foreseeable pharmaceutical applications,”
said Dr. James Demers, PhD, JD, Gotham Patent Services LLC, who
represents the inventors and directs the international patenting
effort. He further added, “In addition, the inventors have
also filed an original PCT application that covers the
nanoviricides® anti-viral substances.”
These compositions result in self-assembling polymers that we
call “TheraCour®“ polymers (or “pi-polymers”), and possess
significant advantages over the earlier block-copolymer systems,
hard nanoparticle systems, as well as liposomal and emulsion
systems, that are now advancing in nanomedicines development.
The TheraCour polymers result in polymeric micelles that can be
used to encapsulate active pharmaceutical ingredients (APIs) to
develop superior drugs where needed. Of greater importance to
NanoViricides, they are capable of direct targeting to any desired
surface with defined specificity, such as a virus particle.
The current first generation nanoviricides® drug candidates have
achieved very high levels of effectiveness only by employing the
specific targeting ability of the TheraCour polymer systems. These
first generation drugs did not require encapsulation of any
additional APIs to achieve their high levels of effectiveness. The
Company believes this has simplified the drug approval process for
us, because the specifically targeted nanoviricide polymer we make
is itself the drug in these cases.
In addition, with this technology, the Company has the ability
to develop drugs against intractable viral diseases wherein very
little virus may be present in circulation. In such cases, the
Company can employ the approach of encapsulating multiple antiviral
APIs that act by orthogonal mechanisms, and deliver the payload
specifically to infected cells by using ligands that bind
preferentially to infected cells. Drug combinations are known to
often provide enhanced synergistic effectiveness, and have been
approved in viral diseases such as HIV/AIDS and Hepatitis C. The
encapsulation approach is known to be superior to the simple
formulated “fixed drug” combinations approach that is being
employed at present. Nevertheless, fixed drug combinations result
in the conventional approach of attacking all cells, and are not
restricted to attacking infected cells preferentially, and thus are
expected to be relatively toxic. Our next generation nanoviricides
approach is anticipated to require significant further development
and resources. The Company is therefore focusing at present on its
wide drug pipeline of six antiviral projects, namely injectable
FluCide™, oral FluCide™, DengueCide™, HerpeCide™, HIVCide™, and the
broad-spectrum drug for viral diseases of the external eye.
In addition to this basic PCT application that covers the
“pi-polymer” structure itself, another PCT application that
discloses making antiviral agents from the TheraCour family of
polymers and such structures is in various stages of prosecution in
several countries, and has already issued in at least seven
countries and regions.
The original “pi-polymer” international application was filed
under the Patent Cooperation Treaty (PCT) system in 2006. Several
other patents have already been granted previously in this patent
family in various countries and regions, including Canada, Europe,
Israel, ARIPO, China, HongKong, Japan, Mexico, New Zealand, OAPI,
Vietnam and South Africa, and the USA. Prosecution in several other
countries continues.
The patents are being issued to the inventors Anil R. Diwan,
PhD, Jayant G. Tatake, PhD, and Ann L. Onton, all of who are among
the founders of NanoViricides, Inc. The patents have been assigned
to AllExcel, Inc., the Company at which the ground-breaking work
was performed. AllExcel, Inc. has contractually transferred this
intellectual property to TheraCour Pharma, Inc.
NanoViricides, Inc. holds exclusive, worldwide, perpetual,
licenses from TheraCour Pharma, Inc. to these technologies and
patents for a broad range of antiviral applications and diseases
that include all Influenzas including Asian Bird Flu Virus, Human
Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV),
Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV), Dengue
viruses, Rabies virus, Ebola/Marburg viruses, Japanese Encephalitis
virus, as well as viruses causing viral Conjunctivitis (a disease
of the eye) and ocular herpes.
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
that 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.
NanoViricides, Inc.Amanda Schuon,
310-550-7200info@nanoviricides.com
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