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® 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®. The study data indicated that during a six-hour testing
period, the Hemopurifier® 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® 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® could open the door
for drugs previously considered incapable of providing clinical benefit as
a stand-alone therapy.”
The Aethlon Hemopurifier® is a medical device designed for the single-use
removal 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® 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) and
the 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® to countries that request the
Hemopurifier® 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 mortality
rate 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 demonstrate
effectiveness 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, combined
with the removal of infectious H5N1 virus would be clinically beneficial to
infected patients. Corresponding to this belief, the Hemopurifier®
targets the rapid removal of both infectious H5N1 virus and
immunosuppressive H5N1 hamagglutinin from circulation. As a result, Aethlon
believes the Hemopurifier® 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-manages
for 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 .
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