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NanoViricides Reports Anti-HIV Efficacy Equivalent to HAART Drug Cocktail Treatment in Animal Study, Successfully Advancing its HIVCide Lead Optimization Program
WEST HAVEN, CONNECTICUT - July 25, 2011 - NanoViricides, Inc. (OTC BB: NNVC) (the
"Company")reports that its lead anti-HIV candidate achieved anti-HIV efficacy equivalent to a HAART
(highly active anti-retroviral therapy) triple drug cocktail in its recently completed animal study.
Treatment with the lead anti-HIV nanoviricide reduced HIV levels and protected the human T cells
(CD4+/CD8+) to the same extent as treatment with the HAART cocktail. The three drug HAART cocktail
used for comparison in this study is one of the combination therapies recommended for initial therapy in
humans. No evidence of drug toxicity was observed. The lead candidate will now undergo further
optimization.
This HIV study substantiates and verifies the Company's previous results in which nanoviricides were
found to have a significant therapeutic effect, equal to or superior to the same HAART therapy protocol in
a SCID-hu Thy/Liv mouse model study.
The Company believes that the anti-HIV nanoviricides act by a different mechanism than all the current
components of HAART therapy regimens. We believe that the nanoviricides bind to the virus particles by
mimicking the cellular structures to which the virus binds. As such, nanoviricides would be able to
complement the various HAART therapy regimens with added therapeutic benefits. The Company
believes that such a combination therapy that includes HIVCideT would possibly achieve a "functional
cure" of HIV/AIDS.
Although functional cure is not a complete cure, it would allow an infected person to continue normal life
even after discontinuation of therapy, maintaining undetectable viral load until a recurrence. The same
therapy could be repeated on recurrence, or therapy could be adjusted. A functional cure is the highly
sought after goal of HIV/AIDS therapy at present.
"Creating an adjunct drug that acts by a novel mechanism complementing the current HAART therapy is
becoming extremely important. The HIV virus mutates constantly resulting in failure of HAART therapy
regimens. In some countries, it has now mutated to such an extent that in up to 40% of patients the
standard HAART therapy has become ineffective," said Eugene Seymour, MD, MPH, the CEO of
NanoViricides. He went on to say that "HIVCide would present a highly effective option for these
patients in particular, and to all HIV-infected persons in general".
An example of the success of our "lead optimization program" was the improvement noted in results
obtained with FluCideT for influenza. Over only a few cycles of optimization the Company has
substantially improved effectiveness of its anti-influenza drug candidates. In the very first anti-influenza
study the Company believes its unoptimized initial candidates were about eight times better than
oseltamivir. After optimization, the current FluCideT optimized candidate was found to exhibit a 1,000-
fold greater viral load reduction than the standard influenza treatment, viz. oseltamivir (TamifluŽ) that
only demonstrated a two fold decrease in the same total lethality-based animal model.
"We are pleased with the results of this study in which the best nanoviricide candidate was as good as
HAART cocktail therapy," said Anil R. Diwan, PhD, President of the Company, adding, "A nanoviricide
is composed of two separate parts connected together. We are able to optimize these two parts separately.
The polymeric micelle structure that attacks the virus is the real workhorse. However, it is brought to the
virus by virtue of binding of the ligand. The ligand that binds to the virus is a critical part which targets
the workhorse to the enemy virus. The results of the current study have provided important insight to
guide the next cycle of chemical optimization. We clearly know now that we are on the right path."
The study was performed using the standard SCID/huThy/Liv mouse model. In this model,
immunodeficient SCID mice are "humanized" by implanting donor human thymus and liver lymphoid
tissue and the human tissue implants are allowed to grow to a mature state. The humanized animals with
mature human lymphoid tissue implants are then infected with HIV-1. The nanoviricide-treated
humanized animals were dosed 8 times while those treated with the HAART therapy were dosed daily for
the duration of the study. Analysis of the implanted human lymphoid tissue at 24 and 48 days after HIV
infection revealed that the HIV viral load in the implant was markedly reduced upon treatment as
compared to untreated animals. Viral load reduction in both the nanoviricide-treated mice and the
HAART-treated animals was equivalent. Of equal clinical importance, the "double positive", CD4+/
CD8+ human T cells in the implant were protected to the same extent in both the nanoviricide-treated and
HAART-treated groups, as opposed to untreated control group. The study was performed at KARD
Scientific, Inc., Beverly, MA, in a Bio-Safety Level 3 (BSL-3) facility under the guidance of Dr. Krishna
Menon who has extensive experience in pre-clinical evaluation of drug candidates in disease-relevant
animal models.
This animal study was conducted as part of the Company's lead optimization process in the HIVCide
program. The study was designed to compare several ligands that were optimized using in silico or
computer-based modeling studies to develop chemicals expected to mimic the binding interaction
between HIV gp120 and human CD4, and potentially interfere with this interaction. HIV virus surface
protein gp120 is involved in binding to the human T cell receptors CD4, CCR5 and CXCR4. The binding
of HIV gp120 to CD4 is critical for HIV entry into human T cells with their subsequent destruction by the
virus. After binding to CD4, the virus also binds to another receptor called CCR5, which then allows the
virus to enter the cell. Instead of binding to CCR5, the virus may bind to a different receptor called
CXCR4 as a substitute, leading to the same effect. Thus CD4 binding is known to be critical in the HIV
infection process.
The ligands tested in this study were designed to mimic the binding of CD4 to which the HIV gp120
binds in a conserved fashion. HIV gp120 continues to bind human CD4 in the same fashion in spite of all
of the mutations that the HIV virus undergoes. Experiments have also shown that if HIV is engineered so
that it does not bind to CD4, then the particle is rendered non-infectious.
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NanoViricides, Inc. (www.nanoviricides.com)
is a development stage company that is creating special purpose
nanomaterials for viral therapy. The Company's novel nanoviricideT 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 forwardlooking
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.
Contact:
NanoViricides, Inc.
Amanda Schuon, 310-550-7200
info@nanoviricides.com
Reproduced with permission - "NanoViricides, Inc. "
NanoViricides, Inc.
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