Aethlon Medical (Nasdaq:AEMD) CEO Jim Joyce Discusses the
Forthcoming Concussion Movie and CTE Research
Research
Being Conducted by Aethlon's Exosome Sciences Subsidiary
Source: Gail Dutton of The Life
Sciences Report (12/22/15)
Exosome Sciences, a majority-owned
subsidiary of Aethlon Medical Inc. (AEMD:NASDAQ), is pioneering the potential
use of an exosome-based biomarker to diagnose chronic traumatic encephalopathy
(CTE), a condition that otherwise can only be identified postmortem. As James
"Jim" Joyce, executive chairman, tells The Life Sciences Report,
other companies are exploring this approach in oncology, but Exosome Sciences
is the only company advancing an exosome-based candidate to diagnose CTE.
Read this article in full at http://www.investorideas.com/news/2015/biotech/12231.asp
Management Q&A: View From the
Top
The Life Sciences Report: How did Exosome Sciences, a majority-owned
subsidiary of Aethlon Medical Inc. (AEMD:NASDAQ), come to be?
James Joyce: Exosome Sciences grew out of our
scientific advances at Aethlon Medical, where we have pioneered the development
of affinity biofiltration therapies that eliminate life-threatening disease
targets from the circulatory system. We formed Exosome Sciences to evolve
exosome isolation techniques that we developed at Aethlon Medical for
therapeutic purposes into a diagnostic setting. Exosomes are very stable
nanometer-size vesicles that transport disease-specific cargos throughout the
body.
In the case of neurological
disorders, we pursued a belief that it might be able to isolate
disease-specific exosomes that crossed through the blood-brain barrier and into
the blood, thus establishing the possibility of liquid biopsy that could detect
and monitor CTE, Alzheimer's disease and perhaps other neurological disorders.
We have since translated this belief into the discovery of a biomarker known as
a TauSome™, which is sometimes referred to as exosomal tau.
TLSR: What is CTE, and why did you choose it as your lead
indication?
JJ: CTE is a progressive neurological disorder that is often
found in the brains of athletes, military personnel and other individuals who
have suffered from repetitive head impacts. The hallmark of the disease is the
excessive buildup of tau protein in the brain. Postmortem autopsies conducted
by researchers at the Boston University CTE Center have identified CTE in 87 of
91 examined brains of former National Football League (NFL) players. Not a very
encouraging statistic.
CTE can lead to progressive
reduction in neural functions, depression, confusion and severe headaches. At
present, the diagnosis can only be made through postmortem autopsy of brain
tissue. We hope to change that unfortunate reality.
TLSR: If it can't be diagnosed accurately, it can't be treated
accurately. Correct?
JJ: That's correct. You have to understand the pathogenesis of
the disease, which first starts with diagnosing the underlying condition. We
think targeting the TauSome as a biomarker will unlock the potential to
diagnose CTE in living individuals, and, at the same time, TauSomes could also
evolve to become a therapeutic target in the future.
TLSR: Could other biomarkers do this as well?
JJ: At present, the only other CTE biomarker we're familiar
with is tau protein itself. Unfortunately, tau protein is not very stable and
is very difficult to find in the circulatory system. Inversely, our TauSome
biomarker is quite stable and can be readily found in the circulatory system.
As a result, we are able to quantify changes in TauSome levels.
At present, our TauSome biomarker is
being studied as the basis for a blood-based test to identify CTE in a clinical
study called "Diagnosing and Evaluating Traumatic Encephalopathy using
Clinical Tests" (DETECT). The DETECT study is being conducted by the
Boston University CTE Center, and it is the first CTE project ever funded by
the National Institutes of Health, with additional support coming from a number
of other government agencies.
The DETECT study enrolled former NFL
players and same-age control athletes who played noncontact sports. The goal is
to establish a test that can identify CTE in living individuals. To date,
preliminary observations indicate that the former NFL group has significantly
higher TauSome levels as compared to the control subjects. A manuscript that
fully details the study results is pending potential publication.
TLSR: What is the next step in developing TauSome?
JJ: The next step is to continue our work in the DETECT study.
We plan to continue following and testing TauSome levels in the former NFL
players who were enrolled in the study. Then, we plan to work with our
collaborators to establish further validation studies. After that, we would
like to apply what we have learned in CTE to Alzheimer's disease and other
neurological conditions.
TLSR: Are there any other companies working with exosomes for
diagnostics?
JJ: A lot of exosome-related research is occurring at the
academic level, and there are some companies that are investigating exosomes as
potential biomarkers for a variety of oncology indications. However, to our
knowledge, there's no other company looking for an exosome-based biomarker to
detect and monitor CTE. In the meantime, we have filed multiple patents to
protect our discoveries.
TLSR: When and how did you first become involved in this
research?
JJ: We first got involved when Tom McHale, a former high school
and college teammate of mine at the University of Maryland, died in 2008. Not
long after his death, the research team at the Boston University (BU) CTE
Center presented data at the 2009 Super Bowl that indicated Tom had suffered from
CTE. The integrity of the scientific research advanced by the BU team would
define CTE as a disease and forever change the way the NFL and other sports
franchises treat head injury.
Immediately after Tom's postmortem
diagnosis, I reached out to the folks at BU and applauded their efforts to
identify CTE, but pointed out that we needed to find a biomarker to identify
those who might have a predisposition to suffer from CTE.
This led to a project where we
sought to isolate certain markers directly from brain tissue of former players.
We didn't have initial success. But then, based on exosome-related studies that
we were conducting at Aethlon, we began to understand the possibility that
exosomes might be moving across the blood-brain barrier, carrying a biomarker
for CTE. Then, we had the good fortune of being invited by the BU team to
conduct tests as part of the DETECT study. This gave us access to a unique
patient population that's at high risk for developing CTE.
Tom McHale was the second former NFL
player who was diagnosed with CTE by the BU team. The presentation of his
diagnosis at the Super Bowl became an inflection point for media coverage that
would introduce the disease of CTE to the mainstream.
Interestingly enough, the first NFL
player to be diagnosed with CTE was Mike Webster, an All-Pro center who played
for the Pittsburgh Steelers. In his case, the autopsy was performed by Dr.
Bennet Omalu, who was not affiliated with the BU research team. Regardless,
Mike's death became the impetus for the forthcoming movie
"Concussion," which is scheduled to be released on Christmas day.
This movie will no doubt increase the dialogue on the issue of CTE in NFL
players.
In 1984, I was a member of a Denver
Broncos football team that went 13–3 and was the AFC Western Division Champ. In
the first round of the playoffs, we hosted the Pittsburgh Steelers, who
unfortunately beat us 24–17. Mike Webster was the starting center, and the
guard who played next to Mike was Terry Long, who would also be diagnosed with
CTE. He committed suicide by drinking antifreeze. Regardless, it will be
interesting to see how they are portrayed in the movie. The list of former
players who have been diagnosed with CTE after committing suicide is getting to
be quite long.
TLSR: Do you believe that CTE and other neurological conditions
eventually will be diagnosed through blood-based liquid biopsy?
JJ: I do. If somebody had asked me that question a few years
ago, I'm not sure I could have responded with a significant level of confidence.
However, today, based on preliminary observations, I think this is very much a
possibility.
While more studies will need to be
conducted, I can envision that professional sports franchises, the NCAA
(National Collegiate Athletic Association), the military and other
organizations would want to know the TauSome levels of participants so they can
monitor changes over time.
TLSR: What milestones do you anticipate in the coming year?
JJ: The most significant near-term milestone would be the
publication of TauSome data from the DETECT study. We also plan to continue
following and testing TauSome levels of the NFL players who were enrolled in
the DETECT study. Additionally, we need to work with our collaborators to
establish further validation study protocols and then apply what we have
learned to Alzheimer's disease and other neurological disorders.
TLSR: Is there anything else investors should know about Exosome
Sciences?
JJ: That Exosome Sciences is a majority-owned asset of Aethlon
Medical, and that its endeavors might be underappreciated and overshadowed by
the therapeutic advances we are making at Aethlon Medical. At this point in
time, Exosome Sciences shares members of the management and research teams at
Aethlon Medical, but has scientific collaborators who are thought leaders in
the neurology field.
TLSR: What should investors know about Exosome Sciences'
finances?
JJ: The nice thing about forming Exosome Sciences as an
independent asset is that it can be financed independently without burdening
Aethlon Medical's balance sheet. Aethlon Medical's focus is therapeutics. We
have an ongoing FDA-approved clinical study to demonstrate the safety of our
technology as a broad-spectrum countermeasure against viral pathogens, and we
are also advancing immuno-oncology studies that we hope to leverage into human
trials.
TLSR: If investors are interested in Exosome Sciences, does that
mean they should be investing in Aethlon?
JJ: Yes, as we are not presently offering shares of Exosome
Sciences to accredited or institutional investors.
TLSR: Thank you very much.
Jim Joyce is the founder of Exosome Sciences and founder,
chairman and CEO of Aethlon Medical (AEMD:NASDAQ), which maintains majority
ownership in Exosome Sciences. Under Joyce's leadership, Aethlon pioneered the
creation of affinity biofiltration devices to treat life-threatening diseases.
Time Magazine recently named the Aethlon Hemopurifier® to be one of the "Top
25 Inventions" and one of "11 Remarkable Advances in Healthcare"
based on the Hemopurifier's ability to address a broad-spectrum of viral
pathogens, including the successful treatment of Ebola virus. In the field of
exosome biology, Joyce has co-authored exosome-related publications and is
co-inventor on exosome-specific patent submissions. Prior to founding Exosome
Sciences and Aethlon Medical, he was managing director at James Joyce &
Associates, founder and CEO of Mission Labs, Inc. and was a member of the
Denver Broncos Football Club of the National Football League. Joyce is a
graduate of the University of Maryland.
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