NanoViricides Inc. (NNVC)

[Ubertino]

Volume 4 • Number 10 • March 8, 2006
Reprinted with permission from NanoBiotech News, published by NHI Publications, Atlanta, GA. Copyright © 2006.
All rights reserved. For subscription information call [phone] or visit http://www.nanobiotechnews.com.

By Marie Powers

Initial test results of a nanoviricide material,
the anti-influenza drug FluCide-I, have
“exceeded expectations” of NanoViricides, Inc.
(Pink Sheets:NNVC), which is developing the
nanomedicine.

The West Haven, CT-based company conducted
the study to establish performance characteristics
of its nanoviricide in preparation for
an upcoming trip to Vietnam. NanoViricides previously
signed a memorandum of understanding
with the government of Vietnam providing
access to resources and materials for the development
of drugs to combat a large number of common
influenza strains, Highly Pathogenic Avian
Influenza (HPAI subtypes, including H5N1), and
rabies -- still an important pathogen in Southeast
Asia. (See NanoBiotech News, Jan. 25, 2006, p. 1.)

Anil R. Diwan, PhD, NanoViricides’ chairman
and president, is inventor of the nanomaterial
that forms the base of the nanoviricide, which
the company calls TheraCour (therapeutic
courier). TheraCour polymers incorporate a specially
designed polymeric micelle material that
allows multi-point targeting of a specific virus in
a Velcro-like effect and that can encapsulate
active pharmaceutical ingredients for attacking
the viral genome -- thus creating the biotech
equivalent of a guided missile.

Privately held TheraCour Pharma, Inc. -- also
co-founded by Diwan and based in New Haven,
CT -- has applied for a patent on the TheraCour
nanomaterials. NanoViricides holds an exclusive,
unlimited license for use of the TheraCour nanomaterials
and development of nanoviricide
antiviral agents against certain viruses. Previously,
Diwan invented polymeric micelles for
biopharmaceutical use, for which he holds a U.S.
patent with colleagues at the University of Massachusetts.

1
NanoViricides continues to develop new
nanomaterials in-house and file new patents.
While much of the company’s attention is currently
focused on a treatment for avian flu,
NanoViricides also is developing treatment
strategies for HIV/AIDS and hepatitis B and C.
The company went public last summer in a
reverse merger with Miami, FL-based EDot.com,
Inc. (For additional background, see NanoBiotech
News, July 13, 2005, p. 1.)

In December, NanoViricides reported that
preclinical studies of its base polymer nanomaterial
had proven safe in animal studies that used
the equivalent of 50 times the projected human
dose. The current study, also conducted by
Krishna Menon, PhD, VMD, MRCS, the company’s
chief regulatory officer, was designed simply
to determine whether attaching a targeting ligand
to the company’s nanomaterial would have any
effect on the H2N1 (common influenza) strain.

Data is strong enough to file IND
While a complete report about the influenza
test results will not be ready until later this
month, Diwan is clearly excited about the preliminary
results, which suggest the virus-targeted
polymer -- even without an encapsulated pharmaceutical
-- shows substantial efficacy in mice,
which Menon proposes is sufficient to file an
investigational new drug (IND) application with
the U.S. Food and Drug Administration (FDA).
“I don’t have the actual data yet,” Diwan
cautions, “but we’re seeing magnitudes of efficacy
improvements over the ligand. These initial
results exceeded our expectations and indicate
we are on target to meet the priority goal set by
management to develop the world’s leading therapeutics
for influenza A and bird flu.”

Drugs that are currently available or in
development against viral threats such as
influenza are based on technologies designed to
interfere only with steps in the replication cycle
of the virus, Diwan points out. Nanoviricides, on
the other hand, take a completely new approach
by blocking and dismantling the virus particles
before they can infect a cell, thereby controlling
the presence of the virus in the blood.
“The intent here was not to make a drug,”
says Leo Ehrlich, CPA, the company’s chief financial
officer. “This was a scientific experiment. But
the technology performed so well that Dr. Menon
believes it is probably better than anything out
there already.”

Diwan expects to release data once the company
has analyzed the complete test results. In
the meantime, NanoViricides is working with an
overseas governmental institution with access to
this year’s prevalent bird flu strains to study the
efficacy of nanoviricides, dubbed AviFluCide,
specific for targeting to H5N1 and other HPAI
viruses.

“We expect our new candidates to perform
even better than the tested material,” Diwan tells
NanoBiotech News.

Potential pharma partners line up
In conjunction with an expected IND filing,
NanoViricides also is positioned to begin licensing
FluCide to major pharmaceutical partners. In
fact, potential licensees already have begun making
inquiries, according to Ehrlich.

NanoViricides also plans to raise additional
cash to complete its preclinical and early human
studies.

“We’re talking to a top-tier investment banking
firm in New York right now,” Ehrlich says.
The company does not plan to publish any
papers or to present its technology at industry
conferences anytime soon so that staff can focus
on the work at hand. With only a short history as
a public company, NanoViricides “needs to
develop the biological information to take to the
FDA before we can say we’re ready to file an
IND,” Diwan says.

“We’re past the research project stage,”
Ehrlich adds. “We’re at the point where we really
are focused on making a drug. We have limited
resources, limited people, and limited finances,
and in that environment publishing is a distraction.
People will learn about us as we achieve
results.”

NanoViricides’ stock closed on March 7 at
$1.77.
Editor’s Note: Contact Anil Diwan at (203) 937-
6137 or Leo Ehrlich at [phone].
Reference

1. U.S. Patent No. 6,521,736: Amphiphilic polymeric
materials.

Reprinted with permission from NanoBiotech News, published by NHI Publications, Atlanta, GA. Copyright © 2006. All
rights reserved. For subscription information call [phone] or visit http://www.nanobiotechnews.com.

*******************************

Noted the following IMPORTANT bits:

--“The intent here was not to make a drug,”
says Leo Ehrlich, CPA, the company’s chief financial
officer. “This was a scientific experiment. But
the technology performed so well that Dr. Menon
believes it is probably better than anything out
there already.”--

--potential licensees already have begun making
inquiries--

--“We’re talking to a top-tier investment banking
firm in New York right now,”--

--Diwan is clearly excited about the preliminary
results, which suggest the virus-targeted
polymer -- even without an encapsulated pharmaceutical
-- shows substantial efficacy in mice--

That is like I read today in a new patent filing:

United States Patent Application 20060045917
Kind Code A1
Yu; Eukki Qi March 2, 2006

Method of conveying matter into targeted cells in a human body

Abstract
A method of conveying matter to targeted cells in a human body, including the steps of providing a predetermined amount of substance desired to be conveyed to the human body, embracing the substance with a predetermined amount of carrier to form a nano-size dosage form and administrating the nano-size dosage form to the human body. The carrier is capable of traveling around the human body through the nervous system of the human body along with the substance desired to be conveyed. The substance to be conveyed includes a wide range of substances such as medication, food supplements, or vitamins. The method conveys matters that are especially useful in curing illnesses or diseases. Even when used alone, the carrier helps curing illnesses or diseases.
http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fn...

AMAZING - the carrier ALONE works wonders!!!!!

We are NOT alone!