AZUSA, Calif., Sep 10, 2008
(BUSINESS WIRE) -- Viral
Genetics, Inc. (Other
OTC:VRAL), a biotechnology
company that discovers and
develops immune-based
therapies, announced today
it has completed an initial
study that aims to unlock
the mysteries behind Lyme
Disease, which could also
potentially offer answers to
other immune-based diseases
including HIV/AIDS. In
addition, a $25,000 gift has
been awarded from an
undisclosed source to
further explore this new
model in Lyme Disease
through follow-on studies
which researchers, including
lead investigator Professor
M. Karen Newell, PhD,
Professor at the University
of Colorado at Colorado
Springs, hope will serve to
reconcile the long-standing
and controversial debate in
the medical community over
treatment methods for Lyme
Disease.
"Since the addition of
Professor Karen Newell to
our existing Harvard team
and as a result of our
recent promising studies
with our new model in
HIV/AIDS, we have found that
the model has potential
promise in Lyme Disease,"
said Monica Ord, SVP of
corporate development and
communications for Viral
Genetics. "Through the
generosity of an undisclosed
philanthropist, we will not
only be answeringkey
questions for Lyme Disease,
but with this new data, the
company will also be
accelerating our ongoing
studies in HIV/AIDS."
Lyme Disease and Testing
Challenges
Lyme is mainly found in the
eastern United States with
smaller risk areas on the
west coast. It is caused by
the transmission of the
Borrelia burgdorferi
spirochete via the bite of
the blacklegged Ixodes tick.
Additional species are found
in Europe and northern Asia.
Lyme Disease has been
reported in all 50 states
with the highest incidence
along the eastern seaboard,
Wisconsin, Minnesota and
northern California. The CDC
reports a 100% increase in
cases of Lyme Disease in the
U.S. from 1991-2006, while
recognizing that at least
ten times more cases may go
unreported. In 2005 alone,
23,305 cases were reported
in the U.S.
Regardless of location,
primary symptoms of Lyme
Disease are characterized by
persistent fatigue, chronic
musculoskeletal pain, and
subjective cognitive
slowing. Some authors refute
the "chronic" label and
instead attribute the
symptoms to coincidence of
the initial infection.
Lyme testing is a challenge
because symptoms vary and
often mimic flu-like
symptoms. The bite may not
immediately result in
antibody production so early
negative diagnosis is an
issue. The organism is also
difficult to culture and
slow growing to further
complicate detection.
Current Methods of
Treatment
Initial treatment of Lyme
(regardless of stage) has
been conventional
antibiotics. Most cases
caught early are cured by
this treatment. Chronic Lyme
Disease is that which
persists past the
conventional antibiotic
therapy. The earlier
treatment starts, the
greater the chances for a
complete recovery, but the
difficulty in diagnosis can
delay treatment and
treatment success.
The Controversy Over
Treatment of Lyme Disease
Research on chronic Lyme
Disease, including symptoms
related to the central
nervous system and
arthritis, has generated
inconclusive and
controversial results. Some
researchers contend Lyme is
driven by chronic infection
and recommend patients be
treated with antibiotics for
the long term. Others
support the hypothesis that
the disease is the result of
autoimmune T-cell activation
that occurs subsequent to
the initial infection or
after the infection has
cleared.
"Our hopes are that the
information acquired from
this very important study,
may act as a bridge between
those who contend that Lyme
Disease is an active chronic
infection and those who feel
it is an autoimmune trigger.
The answer to this question
is of great importance for
all those suffering in the
Lyme community. Only through
this information can we
begin to formulate more
successful treatment
regimens for the chronically
ill," said Dr. Steven
Harris, co-investigator,
Associate Professor Stanford
University.
Study Aims to Unlock
Mysteries, Reconcile Debate
The Viral Genetics proposal
describes a potentially
novel mechanism in which
bacterial infection with the
pathogen Borrelia burgdorfii
activates the immune system.
The new model suggests that
the nature of the immune
response may be responsible
for the pathology of the
disease and that targeted
peptide therapy has the
potential to resolve disease
symptoms.
"The model reconciles both
the initial disease and
accounts for the consequent
processes that appear
pathologically similar to
autoimmune disease, whether
the Borrelia organisms
survive in the host or not,"
said Dr. Newell, lead
investigator of the study
team.
A Gift To Support Further
Research
An undisclosed
philanthropist has provided
a $25,000 gift that will go
towards additional research
of this new model in Lyme
Disease being conducted by
Dr. Newell.
"We are so grateful for
this gift," said Dr. Newell.
"It will allow us to test
this new model in initial
'proof of concept'
experiments that relate
infections with a kind of
immune response that
develops in certain people,
in a genetically determined
manner, that may lead to
chronic, inflammatory
disease. The model provides
a different perspective on
how both the pathogen and
the immune response may
contribute to chronic
disease instead of full
recovery from infection."
Research in HIV/AIDS May
Lead to Breakthrough in Lyme
With a commitment to
discovering and developing
immune-based therapies for
HIV and AIDS using its
thymus nuclear protein
compound (TNP), Viral
Genetics' new model was
initially proposed solely
for HIV/AIDS. However, by
unraveling the mechanism of
TNP, Dr. Newell identified
its potential promise in
other diseases including
Lyme Disease.
"This new model shows
promise, and we look forward
to what further research
could potentially yield for
the many thousands of people
afflicted with this
mysterious disease
worldwide, and other
immune-based diseases such
as HIV/AIDS," added Newell.
About Viral Genetics
Viral Genetics, Inc. is a
biotechnology company that
discovers and develops
immune-based therapies for
HIV and AIDS using its
thymus nuclear protein
compound (TNP). The company
recently entered into an
Exclusive License Agreement
with the University of
Colorado and V-Clip
Pharmaceuticals (a
subsidiary of the Company)
to license technology
developed by M. Karen
Newell, PhD that appears to
explain TNP and provide a
means to optimize therapies
based on TNP for future
clinical trials. TNP may
have other potential
applications for other
infectious, autoimmune, and
immunological deficiency
diseases that the company
intends to study in the
future. Viral Genetics
believes that its
investigational HIV/AIDS
drug based on TNP, called
VGV-1, represents a unique
approach to treating HIV due
to the apparently novel
mechanism, low toxicity
profile, simple dosing
regimen, and short-course of
treatment. As a type of
immune-based therapy, it
focuses on boosting the
immune system to allow the
body to fight HIV more
efficiently. VGV-1 has been
studied in five human
clinical trials for the
treatment of HIV / AIDS.
Online at
www.viralgenetics.com
This news release
contains forward-looking
statements that involve
risks and uncertainties
associated with financial
projections, budgets,
milestone timelines,
clinical development,
regulatory approvals, and
other risks described by
Viral Genetics, Inc. from
time to time in its periodic
reports filed with the SEC.
VGV-1 is not approved by the
US Food and Drug
Administration or by any
comparable regulatory
agencies elsewhere in the
world. While Viral Genetics
believes that the
forward-looking statements
and underlying assumptions
contained therein are
reasonable, any of the
assumptions could be
inaccurate, including, but
not limited to, the ability
of Viral Genetics to
establish the efficacy of
VGV-1 in the treatment of
any disease or health
condition, the development
of studies and strategies
leading to commercialization
of VGV-1 in the United
States, the obtaining of
funding required to carry
out the development plan,
the completion of studies
and tests on time or at all,
and the successful outcome
of such studies or tests.
Therefore, there can be no
assurance that the
forward-looking statements
included in this release
will prove to be accurate.
In light of the significant
uncertainties inherent in
the forward-looking
statements included herein,
the forward-looking
statements should not be
regarded as a representation
by Viral Genetics or any
other person that the
objectives and plans of
Viral Genetics will be
achieved.
SOURCE: Viral Genetics, Inc.
Viral Genetics
Haig Keledjian, 626-334-5310
Copyright Business Wire 2008
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