The Aethlon Hemopurifier(R) Proves Effective in Capturing Bird Flu Virus
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SAN DIEGO, CA, Jan 22 (MARKET WIRE) --
Aethlon Medical, Inc. (OTCBB: AEMD), a pioneer in developing therapeutic
devices for infectious disease, today disclosed that researchers have
demonstrated the effectiveness of the Aethlon Hemopurifier(R) in capturing
the highly-fatal H5N1 strain of the Avian Flu Virus (Bird Flu). In
pre-clinical studies, high concentrations of H5N1 flu virus (approximately 3
million flu virus/ml) were observed to be rapidly depleted from cell culture
fluids when circulated through the Hemopurifier(R). The study data indicated
that during a six-hour testing period, the Hemopurifier(R) removed up to 99.4
percent of infectious H5N1 flu virus. Verification of viral capture was
documented by both real-time PCR and conventional plaque assay (TCID 50)
measurements.
"The data provides real hope for a post-infection treatment against pandemic
influenza and further reinforces the ability of our Hemopurifier(R) to
address a broad spectrum of viral conditions," stated James A. Joyce, Chairman
and CEO of Aethlon Medical. "Additionally, it appears possible that the use
of the Hemopurifier(R) could open the door for drugs previously considered
incapable of providing clinical benefit as a stand-alone therapy."
The Aethlon Hemopurifier(R) is a medical device designed for the
single-useremoval of infectious viral pathogens from blood. The device, which
augments
the natural immune response of clearing infectious viruses and toxins before
cell and organ infection, is positioned to fill a void in treating drug- and
vaccine-resistant infectious diseases. In order to further support the use
of the Hemopurifier(R) as a broad-spectrum treatment countermeasure against
bioterror
and pandemic threats in the United States, Aethlon will include this new data
in a forthcoming submission to the U.S. Department of Health and Human Services
(HHS)
andthe newly established Biomedical Advanced Research and Development Authority
(BARDA).
Based on the significance of the H5N1 data and the continued demonstration of
safety in human studies, Aethlon may on a limited basis provide the
Hemopurifier(R) to countries that request the Hemopurifier(R) as a treatment
option for infected citizens. Researchers at the Battelle Biomedical Research
Center
conducted the H5N1 studies.
It is feared that the H5N1 strain of avian influenza virus, whose
mortalityrate in infected humans exceeds 60 percent, will spark a global
epidemic should it
evolve to allow for an efficient spread of host-to-host infections in humans.
The
recent discovery that H5N1 avian influenza virus can spread via the bloodstream
to organs and other regions of the body typically not attacked by influenza
viruses explains, in part, the high virulence of H5N1 infection and why it
remains a serious pandemic threat. The ability of H5N1 virus to proliferate in
blood represents a causative effect for triggering hypercytokinemia (cytokine
storm), a direct parallel to the Spanish Flu of 1918, which reportedly killed up
to 40 million people within 20 months. Though governments and health agencies
are stockpiling antiviral drugs to treat influenza, these therapies have yet to
demonstrateeffectiveness against human H5N1 infection. A further complication to
drug
treatment has arisen from the clinical observation that drug absorption appears
impaired in severely ill H5N1 patients, and in H5N1 patients with
gastrointestinal symptoms.
Researchers believe the removal of circulating H5N1 hemagglutinin, a
surface protein that is deleterious to the host and immune system,
combinedwith the removal of infectious H5N1 virus would be clinically beneficial
toinfected patients. Corresponding to this belief, the Hemopurifier(R) targets
the rapid
removal of both infectious H5N1 virus and immunosuppressive H5N1
hamagglutinin from circulation. As a result, Aethlon believes the
Hemopurifier(R)
is positioned to benefit infected patients, both as a stand-alone therapeutic,
and
as an adjunct treatment able to improve the clinical benefit of other
candidate therapies.
About Battelle Biomedical Research Center
Battelle Biomedical Research Center is a research group in the National
Security
Global Division of Battelle Memorial Institute, an organization that provides
solutions to some of the world's most important challenges through its three
global
businesses: National Security, Energy Science and Technology, and Health and
Life Sciences. Battelle is the world's largest independent research and
development organization with technology contributions that find their way into
hundreds of commercial products each year. Conducting multi-billion dollars in
global R&D annually, Battelle oversees over 20,000 employees in more than 120
locations worldwide, including five national laboratories that Battelle manages
or
co-managesfor the U.S. Department of Energy. Battelle was recently approved by
the
Department of Health and Human Services (HHS) under the Select Agent Programs
of the Centers for Disease Control and Prevention (CDC) and the Animal and
Plant Health Inspection Service (APHIS) to carry out studies on highly
pathogenic avian influenza, including the H5N1 strain. Battelle was
established in 1929 as a non-profit charitable trust and is headquartered in
Columbus,
Ohio. For more information, visit www.battelle.org.
About Aethlon Medical
Aethlon Medical is the developer of the Hemopurifier(R), a first-in-class
medical device
to treat infectious disease. The Hemopurifier(R) addresses the largest
opportunity
in infectious disease, the treatment of drug- and vaccine-resistant viruses.
The Hemopurifier(R) is a single use extracorporeal device that converges
hollow-fiber filtration technology with immobilized affinity agents to capture
viruses and soluble glycoproteins from the blood. The device has been designed
to
mimic the natural immune response of clearing infectious viruses and
immunosuppressive proteins from circulation. Regulatory and
commercialization initiatives in the United States are focused on
bioterrorthreats, while international initiatives are directed toward naturally
evolving
pandemic threats, and chronic infectious disease conditions including
Hepatitis-C
(HCV) and the Human Immunodeficiency Virus (HIV). Collaborative studies to
demonstrate utility of the Hemopurifier(R) are being conducted with
researchers at the Government of India's National Institute of Virology (NIV),
The
Centers for Disease Control and Prevention (CDC), The United States Army Medical
Research Institute of Infectious Diseases (USAMRIID), and The Southwest
Foundation
for Biomedical Research (SFBR). Aethlon recently demonstrated safety of the
Hemopurifier(R) in a 24-treatment human study and is now conducting
follow-on safety studies at the Fortis Hospital in Delhi, India. The Company
has also submitted an Investigational Device Exemption (IDE) to the U.S.
Food and Drug Administration (FDA) related to advancing the Hemopurifier(R) as
abroad-spectrum treatment countermeasure against category "A" bioterror threats.
Additional information regarding Aethlon Medical and its Hemopurifier(R)
technology can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks
and
uncertainties. Such forward-looking statements involve assumptions, known and
unknown
risks, uncertainties and other factors which may cause the actual results,
performance or achievements of Aethlon Medical, Inc to be materially
different from any future results, performance, or achievements expressed
or implied by the forward-looking statements. Such potential risks and
uncertainties include, without limitation, the Company's ability to raise
capital when needed, the Company's ability to complete the development of
its planned products, the ability of the Company to obtain FDA and other
regulatory approvals permitting the sale of its products, the Company's
ability to manufacture its products and provide its services, the impact of
government regulations, patent protection on the Company's proprietary
technology, product liability exposure, uncertainty of market acceptance,
competition, technological change, and other risk factors. In such instances,
actual results could differ materially as a result of a variety of factors,
including the risks associated with the effect of changing economic conditions
and other risk factors detailed in the Company's Securities and Exchange
Commission filings.
CONTACT:
Aethlon Medical, Inc.
Jeff Richardson
Senior Director, Communications
858-459-7800, ext. 302
jrichardson@aethlonmedical.com
Copyright 2008, Market Wire, All rights reserved.
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