SAN DIEGO, March 19, 2014 /PRNewswire/ -- Aethlon Medical,
Inc. (OTCQX:AEMD), and its diagnostic subsidiary, Exosome Sciences,
Inc. (ESI), announced today that researchers have isolated
brain-derived exosomes released into the bloodstream from
aggressive brain tumors. Through the use of proprietary size
exclusion/lectin/antibody-capture techniques, the Aethlon-ESI
research team was able to identify, quantify, and characterize
circulating Glioblastoma multiforme (GBM) exosomes, which hold
promise as both a disease biomarker and therapeutic target as GBM
exosomes are shed into the circulatory system to promote tumor
growth and stimulate angiogenesis.
"Building on our proprietary method to identify, quantitate and
characterize brain-derived exosomes, we now have the ability to
detect this aggressive cancer early and aid in its treatment,"
stated ESI Chief Scientific Officer, Dr. Douglas Taylor.
Aethlon Medical develops therapeutic filtration devices to
address infectious disease, cancer and other life-threatening
conditions. The Aethlon Hemopurifier® is a first in class medical
device that addresses a broad-spectrum of viral pathogens as well
as tumor-secreted exosomes that promote cancer progression and
suppress the immune system of cancer patients. Aethlon is currently
preparing to launch the first FDA approved clinical study of
Hemopurifier® therapy in the United
States. ESI was established by Aethlon to develop
non-invasive exosome-based "liquid biopsies" that diagnose and
monitor acute and chronic disease conditions.
GBM represents the most common, per capita costly and uniformly
lethal primary brain tumor. GBM comprise 23% of primary brain
tumors in the US and is the most commonly diagnosed brain tumor in
adults aged 45-74 with men being more frequently diagnosed than
women. The prognosis remains poor despite aggressive treatment
modalities. Over the past decade, a median survival time of 12
months has only been marginally improved to 14.6 months as a result
of advances in chemo/radiation and the use of molecularly targeted
agents. Beyond being a candidate target for Hemopurifier® therapy,
the discovery of circulating GBM-exosomes offers a potential new
paradigm in GBM clinical management through a platform technology
to predict tumor regression or progression.
"The ability to characterize disease specific exosomes in
circulation will enable improved diagnosis to identify type and
grade of these most challenging of brain tumors and may
additionally help to advance novel treatment strategies," stated
Dr. Cicek Gercel-Taylor, Clinical
Research Director at ESI.
To date, there have been two critical barriers to successful GBM
treatment. First, there currently is no method for evaluating the
dynamic changes in GBM during therapy. Standard imaging approaches
do not provide metrics of tumor-specific genetic/phenotypic changes
and operative information is expensive, potentially morbid and
limited by errors in topographic sampling. Second, clinicians,
lacking tumor-specific parameters, are unable to effectively
monitor responses to therapy over short time frames. These
limitations are derived from the difficulty in obtaining repeated
biopsies of tumor tissue, and the confounding effects on tumor MRI
of necrosis, inflammation, surgical artifact and edema.
Additionally, the appearance of GBM by current imaging techniques
is not specific, since other lesions such as abscess, metastasis,
and other entities may have a similar appearance. As a result,
clinicians have not been able to adequately evaluate therapeutic
agents designed to target GBM. The objective of the Aethlon-ESI
team is to extend and improve GBM patient quality of life by
resolving the clinical challenges of monitoring patient response to
both established and candidate therapies.
Earlier this month, the Aethlon-ESI research team disclosed that
it was also to isolate brain-specific biomarkers that could have
implications in the diagnosis, monitoring and treatment of
Alzheimer's Disease (AD), Chronic Traumatic Encephalopathy (CTE)
and Traumatic Brain Injury (TBI). The research studies
provided evidence that exosomes can serve as a "liquid biopsy" to
diagnose neurologic conditions. While exosomes from the central
nervous system have previously been identified in the cerebrospinal
fluid, the Aethlon-ESI study identified exosomes carrying
brain-specific markers tau, beta-amyloid, glycoprotein A2B5 and
S100B protein in the peripheral circulation of affected
individuals. The discoveries provide a basis for an
exosome-based platform that could enable the simultaneous
identification of multiple brain specific markers that are
transported across the blood-brain barrier and into the circulatory
system.
CTE is a progressive degenerative disease, which at present can
only be definitively diagnosed postmortem. CTE has been most
commonly found at autopsy in former professional football players
and has also been demonstrated to be prevalent in soldiers exposed
to blast injury. The hallmark of CTE is the accumulation of
tau, an abnormal protein that strangles brains cells in areas that
control memory, emotions and other functions. TBI or
repetitive brain trauma, including concussions and sub-concussive
blows to the head contribute to the onset of CTE.
AD is the most common form of dementia. There is no cure for the
disease, which worsens as it progresses, and eventually leads to
death. Beta-amyloid plaques and neurofibrillary tangles have
long been recognized as a common pathologic hallmark of AD. In
2010, it was estimated that 36 million people worldwide were living
with AD.
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.
About Exosome Sciences, Inc.
Exosome Sciences (ESI), a majority wholly owned subsidiary of
Aethlon Medical, Inc., develops exosome-based solutions to improve
identification and monitoring of acute and chronic conditions. Our
candidate products are focused toward diagnostic advancements in
the fields of oncology, infectious disease and brain injury.
Exosomes represent an optimal diagnostic target as diseased or
injured cells release these particles into body fluids such as
urine, blood, saliva and cerebrospinal fluid where they can be
accessed for analysis. Our exosome-based assays unlock the ability
to identify proteomic and genomic alterations underlying a
wide-range of pathologies, thus allowing for the introduction of
novel non-invasive "liquid biopsies". Additional information
can be found at www.ExosomeSciences.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 ESI will not be
able to commercialize its future products, that the FDA will not
approve the initiation of the Company's existing or future 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, 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
Marc Robins
877.276.2467
mr@aethlonmedical.com
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SOURCE Aethlon Medical, Inc.