Aethlon Medical’s (Nasdaq: AEMD) Exosome
Sciences Announces the Publication of Preliminary Findings of a Blood Test to
Detect Chronic Traumatic Encephalopathy (CTE) During Life
SAN DIEGO, CA, February 25, 2016 – Exosome
Sciences, Inc., in collaboration with majority shareholder Aethlon Medical,
Inc. (Nasdaq:AEMD) and investigators
at Boston University and the University of Washington, announced today the
published preliminary results of possibly the first blood test to detect the
neurodegenerative disease, Chronic Traumatic Encephalopathy (CTE) during life.
An early online version of these findings has been
published in the Journal of Alzheimer's Disease. CTE is associated with
exposure to repetitive head impacts, such as those experienced by American
football players, and can only be diagnosed post-mortem at this time.
The researchers developed a method of
measuring plasma exosomal tau, also referred to as a TauSome™. Exosomes are very small vesicles that are
released from all types of cells throughout the body, including brain
cells. They can be isolated in all body
fluids, including plasma, a component of blood. Exosomes carry within them the
proteins from their cells of origin.
Because exosomes can cross the blood-brain-barrier (a selective barrier
that separates the circulating blood from the brain’s extracellular fluid),
they can provide a unique method of measuring certain aspects of the contents
of brain cells through a blood test.
That is, if the brain-derived exosomes can be isolated in plasma and
then be stained for specific proteins found in the brain cells, researchers can
potentially measure brain proteins through a blood test. That was the goal of this preliminary study.
The ability to diagnose CTE during life
will allow researchers to better determine its incidence and prevalence, to
examine risk factors to understand why some people get CTE and others do not,
and to begin clinical trials of methods aimed at treating and ultimately preventing
the disease. Because CTE is very similar
to Alzheimer’s disease and other related neurodegenerative diseases, the
results of this new study may eventually lead to improved methods of detecting
these other causes of dementia.
For
this study, researchers examined 78 former National Football League (NFL)
players and a control group of 17 former non-contact sport athletes. All
subjects were participants in a larger project that was funded by a grant from
the National Institutes of Health to develop a variety of biomarkers for CTE
conducted at Boston University School of Medicine. Results demonstrated that
plasma exosomal tau was significantly elevated in the group of former NFL
players compared to the control group and that, within the former NFL player
group, the number of tau-positive plasma exosomes was significantly correlated
with performance on standardized tests of memory and psychomotor speed; the
higher the TauSome level, the worse the performance.
“We
are extremely pleased that our initial study data has been published and we
appreciate forthcoming opportunities to further advance our TauSome™ biomarker
as a non-invasive solution to detect and monitor CTE in living individuals,”
stated Jim Joyce, Founder of Exosome Sciences and Chairman and CEO of Aethlon
Medical.
Access
to the on-line version of the publication can be accessed through: http://content.iospress.com/articles/journal-of-alzheimers-disease/jad151028?resultNumber=7&totalResults=48&start=0&q=exosome&resultsPageSize=10&rows=10
The
researchers note that this is a preliminary study and is the first of several
steps necessary to validate a TauSome test to detect CTE and potentially
monitor its progression. The study was limited by a relatively small sample
size and the lack of any additional possible biomarker of CTE. Furthermore,
because of the methods used, the researchers cannot be completely confident
that the exosomes that were isolated definitely came from the brain or that the
specific form of tau that was measured is the same form of abnormal tau found
in CTE. A series of future TauSome
studies are already planned, including collaboration with a multisite, 7-year
$16 million grant recently awarded to Stern and colleagues by the NIH to
develop methods of diagnosing CTE during life.
About Exosome Sciences
Exosome Sciences, Inc., in
collaboration with majority shareholder Aethlon Medical (Nasdaq:AEMD), is
focused on discovering exosomal biomarkers to diagnose and monitor Alzheimer's
disease (AD), Chronic Traumatic Encephalopathy (CTE) and other neurological
disorders. Our TauSome™ biomarker (also
referred to as exosomal tau) is being studied as the basis for a blood-based
test to identify CTE through the DETECT Study being conducted by the Boston
University CTE Center. TauSome™
detection and the use of a TauSome™ biomarker to identify and monitor CTE and
other neurological disorders are protected by multiple patent
applications. Visit www.exosomesciences.com for additional details.
About Aethlon Medical, Inc.
Aethlon Medical (Nasdaq:AEMD) creates
affinity biofiltration devices to treat life-threatening diseases. The Aethlon
Hemopurifier® is a leading broad-spectrum treatment countermeasure against
infectious viral pathogens. The device,
which has been successfully administered to individuals infected with HIV,
Hepatitis C (HCV) and Ebola virus, is currently the subject of FDA approved clinical
studies. Aethlon is also studying the potential use of the Hemopurifier® to
address exosomes secreted by tumors to promote the spread of metastasis and
suppress the immune system of cancer patients.
The Company provides government contracting services to the Defense
Advanced Research Projects Agency (DARPA) related to the development of a
biofiltration device to treat sepsis and maintains majority ownership of
Exosome Sciences, Inc., which is focused on the discovery of exosomal
biomarkers to diagnose and monitor Chronic Traumatic Encephalopathy (CTE) and
other neurological disorders. Additional information can be found online at
www.AethlonMedical.com or you can connect with us on Twitter, LinkedIn,
Facebook and Google+.
This press release contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934 that involve risks and uncertainties.
Statements containing words such as "may," "believe,"
"anticipate," "expect," "intend,"
"plan," "project," "will,"
"projections," "estimate," or similar expressions
constitute forward-looking statements. Such forward-looking statements are
subject to significant risks and uncertainties and actual results may differ
materially from the results anticipated in the forward-looking statements.
Factors that may contribute to such differences include, without limitation,
the Company's ability to maintain its listing on the Nasdaq Capital Market, or
any other national securities exchange, that the Company or its subsidiary will
not be able to commercialize its products, that the FDA will not approve the
initiation or continuation of the Company's clinical programs or provide market
clearance of the Company's products, including products developed by Exosome
Sciences, Inc., 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, the impact of government regulations, patent protection on
the Company's proprietary technology, the ability of the Company to meet the
milestones contemplated in its contract with DARPA, product liability exposure,
uncertainty of market acceptance, competition, technological change, and other
risk factors. The foregoing list of risks and uncertainties is illustrative,
but is not exhaustive. Additional factors that could cause results to differ
materially from those anticipated in forward-looking statements can be found
under the caption "Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended March 31, 2015, and in the Company's other filings
with the Securities and Exchange Commission. Except as may be required by law,
the Company does not intend, nor does it undertake any duty, to update this
information to reflect future events or circumstances.
Investor Relations Contact:
Mike Smargiassi/Brad Edwards
Brainerd Communicators, Inc.
212-986-6667
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Ruder Finn, Inc.
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