SAN DIEGO, Aug. 6, 2014 /PRNewswire/ -- Aethlon Medical,
Inc. (OTCQB: AEMD), today
released the following note authored by its Chairman and CEO,
Jim Joyce.
The current ebola outbreak in West
Africa demonstrates the urgent need for therapeutic
strategies to defend against emerging pandemic threats. It
also highlights why the Department of Health and Human Services
(HHS) has shifted the focus of government biodefense and pandemic
threat initiatives toward broad-spectrum therapies able to target
multiple pathogens. At present, a majority of all infectious
viruses are not addressed by drug therapies, which are designed to
inhibit or block replication of a single viral species.
At Aethlon Medical, we are intersecting advanced biology with
modern plasma membrane technology to rethink the treatment of viral
pathogens. The result is the Aethlon Hemopurifier®, a therapeutic
device that has been validated to capture a broad-spectrum of viral
pathogens and immunosuppressive proteins through affinity binding
to a unique high-mannose structure that is co-opted from the host
(the infected individual) as a means for viruses to evade detection
of the host immune system. We have also discovered that this
signature exists on tumor-secreted exosomes that promote cancer
progression.
We believe our Hemopurifier® is the most advanced and perhaps
only true broad-spectrum countermeasure against emerging pandemic
threats such as ebola, and viral threats that could be weaponized
to purposely infect civilian and military populations. Our belief
is supported by human clinical outcomes and supporting in vitro
studies conducted at leading government and non- government
labs.
Last week, a story published on CNN.com
(http://ireport.cnn.com/docs/DOC-1157208?ref=feeds%2Flatest),
suggested that our Hemopurifier® might be an ebola treatment
cure. In this regard, I want to clarify that we created the
Hemopurifier® to provide a post-exposure treatment strategy to
mitigate illness, suffering, and death resulting from exposure to
viral pathogens. However, we do not represent that our
Hemopurifier® is a cure for ebola. It is designed to augment
the ability of the immune system to overcome infection and to
increase the benefit of drug therapy in disease conditions where an
antiviral agent might be indicated.
I also want to provide clarity on what Hemopurifier® studies
have been conducted specific to the ebola virus. On
October 17th, 2007, Dr. Laura Barrientos at the United States
(US) Centers for Disease Control and Prevention (CDC),
published a report entitled: "The Aethlon Hemopurifier®, A Novel
Strategy to Address ebola and Marburg Haemorrhagic
Fevers."
The report discussed the potential of the Aethlon Hemopurifier®
as a treatment countermeasure against ebola and other filoviruses.
An excerpt from the report follows: "The
Hemopurifier® is an extracorporeal device which converges
hollow-fiber filtration technology with immobilized affinity agents
to allow for the rapid physical removal of virus and soluble viral
glycoproteins from the blood. The device basically mimics the
natural immune response for clearance of circulating virus and
viral toxins. Initial collaborative efforts between the CDC and
Aethlon Medical have demonstrated rapid clearance of viral
particles from cell culture supernatants (t1/2 20-120 min). The
Hemopurifier® was also effective in removing soluble viral
glycoproteins (t1/2 30 min). This knowledge represents the basis to
further investigate in vivo the potential of the Hemopurifier® as a
fast-acting post-exposure intervention to delay disease progression
and, possibly, to improve survival. The data resulting from the
CDC-Aethlon collaboration has led to further studies through a
collaborative research and development agreement with the United
States Army Medical Research Institute for Infectious
Diseases (USAMRIID)." The full report can be accessed online
at: http://www.aethlonmedical.com/assets/001/5017.pdf
In a follow-on disclosure, we reported that the USAMRIID studies
documented that the Hemopurifier® captured approximately 50%
of both wild type and mutant strains of ZEBOV (Zaire strain of ebola) from fluids during one
hour in vitro studies. ZEBOV has the highest virus
case-fatality rate, up to 90% in some epidemics, with an average
case fatality rate of approximately 83% over the previous 27 years.
USAMRIID, serves as the lead laboratory for the U.S. Medical
Biological Defense Research Program, and plays a key role in
national defense and in infectious disease research. USAMRIID
operates the only laboratory in the Department of Defense (DOD)
equipped to study ebola and other highly hazardous infectious
agents requiring maximum containment at bio-safety level four
(BSL-4).
At present, we are preparing to launch the first FDA approved
feasibility studies of Hemopurifier® therapy in the United
States. Under the feasibility study protocol, we will enroll
end stage renal disease (ESRD) patients who are infected with the
Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier
therapy in an infectious disease model. Successful completion
of the feasibility study will set the stage for us to conduct
pivotal studies required for market clearance to treat HCV and
other viral pathogens.
The study will also contribute data toward the human safety
challenge requirement to advance Hemopurifier® therapy as a
broad-spectrum countermeasure against viral bioterror and pandemic
threats (including ebola), whose lethality do not allow for the
administration of clinical efficacy studies. We are actively
investigating Emergency Use Authorization (EUA) approvals based on
our previous human treatment experiences and broad-spectrum
validation studies against viral pathogens. We are also
exploring Humanitarian Use Device (HUD) pathways for orphan
conditions that affect fewer than 4,000 individuals in the U.S.
each year.
Should the outbreak of deadly viral pathogen provide us
with opportunities to treat, we would first request clarity from
the FDA that our response would not threaten our long-term clinical
objectives in the United States.
Additionally, we would request FDA interaction to provide feedback
on data-points that could be collected to support future EUA and
HUD approvals. In this regard, I want to share that we have
initiated our dialog with FDA. The results of these discussions
will determine whether we request an opportunity to treat those
infected with ebola virus.
About Aethlon Medical, Inc.
Aethlon Medical creates
innovative medical devices to address life-threatening diseases.
The Aethlon ADAPT™ (Adaptive Dialysis-like Affinity Platform
Technology) establishes the basis for a new class of therapeutics
that target the rapid elimination of disease enabling particles
from the circulatory system of treated patients. The lead
Aethlon ADAPT™ product is the Hemopurifier®, a device that
addresses a broad-spectrum of viral pathogens as well as
tumor-secreted exosomes that suppress the immune system of cancer
patients. Aethlon is also operating under two government
contracts with the Defense Advanced Research Projects Agency
(DARPA) related the development of a medical device to reduce the
incidence of sepsis. Exosome Sciences, Inc. is a majority owned
Aethlon subsidiary that is advancing exosome-based strategies to
diagnose and monitor cancer and infectious disease
progression. Additional information can be found at
www.AethlonMedical.com
Certain 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, that the FDA will not
approve the initiation of the Company's clinical programs or
provide market clearance of the company's products, future human
studies whether revenue or non-revenue generating of the Aethlon
ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to
improve patient responsiveness to established cancer or hepatitis C
therapies or as a standalone cancer or hepatitis C therapy or as a
treatment for ebola, the Company's ability to raise capital when
needed, the Company's ability to complete the development of its
planned products, the Company's ability to manufacture its products
either internally or through outside companies and provide its
services, the impact of government regulations, patent protection
on the Company's proprietary technology, the ability of the Company
to meet the milestones contemplated in the DARPA contract, 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. The Company
undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
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SOURCE Aethlon Medical, Inc.