Aethlon Medical (AEMD) Note: Extracorporeal Methods to Reduce Inflammation in
SAN DIEGO, Jan. 24, 2013
SAN DIEGO, Jan. 24, 2013 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD),
today released the following note authored by its Chairman and CEO, Jim Joyce.
Yesterday, our President Rod Kenley presented an informative review of
extracorporeal medical device strategies to treat sepsis at the 15th
International Conference on Dialysis. He also had the opportunity to discuss
some of the advances we have made in the field. If you are not familiar with
sepsis, it is a life-threatening blood infection that can trigger multiple
organ failure and is a leading cause of death in intensive care units (ICU).
18 million cases of sepsis are diagnosed around the globe each year and
candidate drug therapies have yet to demonstrate an ability to significantly
improve survival rates.
When we initiated our sepsis research, the prevailing viewpoint seemed to be
that sepsis was triggered by a hyperactive response of the immune system in an
attempt to respond to overwhelming infection. This response is often called a
"cytokine storm." As a result of this predominant viewpoint, many
experimental therapies solely focused on modulating the early inflammatory
response phase of sepsis and did so without much success. As it turns out,
sepsis is far more complex as the exuberant inflammatory immune response
occurring at the outset of sepsis is soon followed by a period of significant
immune suppression. Thus, therapies solely focused on the knocking down the
initial immune response may actually accelerate the development of
immunosuppression, which is associated with a majority of deaths in sepsis.
In other words, while sepsis is triggered by a hyper activation of the immune
response, most sepsis patients actually die from immune paralysis.
As Rod points out in his presentation, evidence suggests that a successful
extracorporeal strategy will have the ability to selectively eliminate
multiple sepsis promoting factors from circulation without disrupting the
production of anti-inflammatory cytokines or other elements that might further
exasperate immune suppression. This is the focus of a strategy we are proudly
advancing with industry colleagues under a contract with the Defense Advanced
Research Projects Agency (DARPA).
There is also an additional factor to consider. An increasing number of
scientific journals are reporting evidence that sepsis related immune
suppression reactivates latent viruses such as cytomegalovirus (CMV) and other
herpes viruses in critically ill patients, which in turn can increase the
severity of sepsis, lengthen the stay in the ICU and increase patient
mortality rates. In one recent publication, active CMV infection was
associated with an 81% higher mortality rate as compared to critically ill
patients without active CMV infection. Cytomegalovirus, or CMV, is a herpes
virus found in more than half of the U.S. population over age 40. Like other
herpes viruses, CMV can remain dormant inside cells for years, causing little
or no apparent illness in healthy people. But in those with weakened immune
systems, such as organ transplant recipients, people receiving chemotherapy,
or people with AIDS, reawakening of the virus can cause serious complications
or even death.
In previously conducted studies, our researchers demonstrated that our
Hemopurifier® is able to capture CMV. That's right, the same Hemopurifier® we
are actively advancing in the treatment of Hepatitis C virus (HCV). As such,
we cannot ignore the possibility that our Hemopurifier® could have utility
during the immunosuppressive phase of sepsis. In Rod's presentation, he also
reports evidence that the affinity agent immobilized in our Hemopurifier® to
facilitate selective yet rapid clearance of circulating viral and cancer
promoting targets is able to bind lipopolysaccharide (LPS) and other factors
implicated in the pathogenesis of sepsis. Perhaps these findings in
combination with industry colleague advances will lead to a device that saves
the lives of sepsis patients.
Rod's presentation is now accessible online at:
About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical
needs in cancer, infectious disease, and other life-threatening conditions.
Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides
the basis for a new class of devices the rapid, yet selective removal of
disease promoting particles from the entire circulatory system. At present,
The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to
address infectious disease and cancer, and a medical device being developed
under a 5-year contract with Defense Advanced Research Projects Agency (DARPA)
to reduce the incidence of sepsis in combat-injured soldiers. For more
information, please visit www.aethlonmedical.com.
About The Aethlon Hemopurifier®
The Aethlon Hemopurifier® is a first-in-class medical device that selectively
targets the rapid clearance of infectious viral pathogens and
immunosuppressive proteins from the entire circulatory system. In the
treatment of Hepatitis C virus (HCV), human studies have demonstrated that
Hemopurifier® therapy may improve immediate, rapid and sustained virologic
response rates when administered in the first few days of standard-of-care
drug therapy. In addition to accelerating viral load depletion,
post-treatment analysis of the Hemopurifier® has documented the capture of up
to 300 billion HCV copies of HCV during a single six-hour treatment. Access
to Hemopurifier® therapy is available on a compassionate-use basis through the
Medanta Medicity Institute (Medicity), a leading center for medical tourism in
India. The Medicity is offering treatment access to infected individuals who
previously failed or subsequently relapsed standard-of-care drug regimens.
The Hemopurifier® is also being offered as a salvage therapy to infected
individuals who suffer a viral breakthrough during standard-of-care therapy.
U.S. studies of the Hemopurifier® are currently pending approval of an IDE
submitted to FDA.
The Aethlon Hemopurifier® and Cancer
In addition to the opportunity to address a broad-spectrum of infectious viral
pathogens, the Hemopurifier® has been discovered to capture tumor-derived
exosomes underlying several forms of cancer. Tumor-derived exosomes have
recently emerged to be a vital therapeutic target in cancer care. These
microvesicular particles suppress the immune response in cancer patients
through apoptosis of immune cells and their quantity in circulation correlates
directly with disease progression. Beyond possessing immunosuppressive
properties, tumor-derived exosomes facilitate tumor growth, metastasis, and
the development of drug resistance. By addressing this unmet medical need,
the Hemopurifier® is positioned as an adjunct to improve established cancer
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 from either compassionate use or non-compassionate use 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 sepsis therapies or as a standalone cancer or hepatitis C therapy or
standalone sepsis therapy, 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,
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.
James A. Joyce
Chairman and CEO
Chief Financial Officer
SOURCE Aethlon Medical, Inc.
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