Aethlon
Medical's (NasdaqCM:AEMD) Biofiltration Platform Tackles Everything from Ebola
to Cancer: CEO James Joyce
Source: Gail Dutton of The Life
Sciences Report (10/28/15)
Aethlon Medical Inc. has pioneered a
novel biofiltration platform that was used effectively against Ebola in 2014.
Now this broad-spectrum platform is being tested against cancer and other
life-threatening diseases. Aethlon CEO James "Jim" Joyce tells The Life
Sciences Report how this device is helping transform modern healthcare.
Management Q&A: View From the
Top
The Life Sciences Report: Aethlon
Medical Inc. (AEMD:NASDAQ) has developed a novel affinity biofiltration
platform that removes disease-enabling particles from the bloodstream. How
effective is it, and what makes it so effective?
James Joyce: At Aethlon Medical, we have
established an expansive therapeutic platform that allows us to target a wide
range of disease-promoting targets from the circulatory system. Our lead
product, the Aethlon Hemopurifier, provides a clinical pathway into infectious
disease and cancer. In 2014, TIME magazine named the device one of the
25 best inventions of the year and also one of the 11 most remarkable advances
in healthcare.
In the case of the Hemopurifer, our
device integrates advanced plasma membrane technology with an affinity lectin
to reduce the presence of infectious disease and oncology targets without
stripping out essential components required for health. The Hemopurifier is
designed for use within the existing infrastructure of dialysis and continuous
renal replacement therapy machines already located in hospitals and clinics
worldwide.
In human studies, we've treated
patients with HIV and hepatitis C. We also received a lot of attention in 2014
during the Ebola outbreak for our response in treating an Ebola patient at
University Hospital Frankfurt. The patient was comatose, with multiple organ
failure. At the time of treatment, he had approximately 400,000 copies per
milliliter of Ebola virus in his blood. After the conclusion of a single
six-and-a-half-hour Hemopurifier treatment, the viral load was next measured at
approximately 1,000 copies per milliliter. Five days later, the virus was
undetectable. The patient made a full recovery and returned home to his wife
and children. This outcome was accomplished in the absence of antiviral drug
therapy.
TLSR: How does this approach compare to drug-based therapies?
JJ: Using infectious viral pathogens as an example, the primary
difference between our techniques and drug techniques is that antiviral drugs
are designed primarily to inhibit replication of the virus, or to fuse to the
virus to inhibit it from continuing to infect healthy cells. It's an additive
therapy.
We, in contrast, are extracting
viral copies from the circulatory system in real time. Blood flows through our
cartridge, which has an affinity to capture viruses and shed glycoproteins
that, oftentimes, are immunosuppressive. So instead of an additive therapy, you
could consider our device a selective subtracted therapy. We also have the
unique ability to elute the biological fluid out of the cartridge after
treatment for quantification. In one hepatitis C patient who was treated
overseas, we determined that during one six-hour treatment we eliminated
approximately 300 billion copies of hepatitis C virus during a single six-hour
treatment.
TLSR: How long is a typical treatment session?
JJ: In clinical studies to date, treatments have ranged from
four to six hours. The longest treatment was the Ebola patient.
TLSR: How does your system work, and does it have any
competitors?
JJ: Historically, therapeutic biofiltration devices have mostly
been limited to the indiscriminate removal of disease-causing particles by
molecule size, through hollow fibers or porous beads. In our case, we're
combining the capabilities of hollow fibers with an affinity lectin that binds
to a unique structure co-opted from the host cell during replication. This
unique structure exists across different species, families, and strains of
viral pathogens. That's what gives us broad-spectrum capability.
In terms of other therapeutic
biofiltration devices, we aren't aware of any competitors that combine a
simultaneous affinity and separation mechanism.
TLSR: What are the potential applications?
JJ: In terms of infectious viral pathogens, people are often
surprised to learn that more than 300 viral pathogens are known to be
infectious to humans. Of those viruses, only nine are addressed with approved
antiviral drug therapies. There is a tremendous need for countermeasures
against Category A pathogens, which are considered bioterror or pandemic
threats. In those cases, we are working to tip the balance in favor of the
immune system, much like we did with the Ebola patient, to rapidly reduce viral
load and allow the patient's immune system a greater opportunity to overcome infection.
For chronic viral conditions such as
HIV or hepatitis C, we look at the ability to address mutant or drug-resistant
virus strains that cause people to fail their antiviral drug therapies. Here,
we can work in conjunction with drug therapies, or as a potential monotherapy
for people who have become fully drug resistant.
TLSR: Where do you envision treatment occurring?
JJ: Initially, we envision that our therapies would be
available in hospitals and dialysis clinics. As we expand into oncology indications,
we would like to have a portable instrument that would allow our technology to
be easily delivered on an outpatient basis, in physicians' offices.
TLSR: How do you envision the Aethlon pipeline building out?
JJ: Right now, we have the ability to interchange affinity
agents to create capabilities against different indications. Today, our primary
focus is on advancing our technology against viral pathogens and expanding the
use of the Hemopurifier into oncology.
We also have a U.S. Department of
Defense contract with the Defense Advanced Research Projects Agency (DARPA), in
which we're utilizing our device platform to create new therapies for sepsis.
Those are our two primary areas of focus.
Long term, we are very excited about
the discovery that our Hemopurifier can capture tumor-secreted exosomes.
When we first started looking at
tumor-secreted exosomes, the medical community consensus was that they were
just cellular debris with no biological function. We believed that these
particles were immunosuppressants. Today, it's well understood that
tumor-secreted exosomes are, in fact, immunosuppressive, and that they also
play a much larger role in cancer progression. That role is related to the fact
that exosomes are seeds that facilitate the creation of metastases, and they
transport other particles that lead to cancer progression. Consequently, the
elimination of circulating tumor-secreted exosomes would address a significant
unmet medical need in cancer care.
Researchers have also reported that
tumor-secreted exosomes trigger apoptosis (programmed cell death) of immune
cells and contribute to drug and chemotherapy resistance. It's also important
to recognize that circulating tumor-exosome load correlates to the stage of
cancer.
We believe that eliminating
circulating tumor-secreted exosomes, in combination with emerging
immuno-oncology drugs, should be clinically tested—especially considering the
possibility that our device could combine with other therapies to improve
treatment outcomes without adding drug toxicity.
TLSR: How will Aethlon make an impact in the oncology sector?
JJ: We believe the elimination of tumor-secreted exosomes could
unlock the capability of emerging immuno-oncology drugs. What better way to
improve the immune system's ability to combat cancer than to have a device that
targets exosome-related immune suppression working in tandem with
immuno-oncology drugs designed to stimulate the ability of the immune system to
combat cancer?
TLSR: Are you working with any other companies to do that?
JJ: We currently are conducting in vitro validation
studies, as well as a study at the University of California, Irvine. We're
recruiting patients with nine different types of cancer to help us determine
which indication we should first pursue.
TLSR: What are the regulatory hurdles? Where are you in the
approval process?
JJ: We have conducted multiple studies overseas, which
contributed to our obtaining approval for an investigational device exemption
(IDE) by the FDA. In the U.S., we are actively moving forward to conduct a
10-patient feasibility study at DaVita Med Center Dialysis in Houston, Texas.
This study provides a gateway into pivotal studies for infectious viral
pathogens, where it is feasible to conduct controlled efficacy studies. The
study protocol is quite similar to a protocol we successfully conducted
overseas. We also hope to leverage this feasibility into future oncology
indications.
TLSR: You mentioned the DARPA sepsis program. Tell me about that.
How is it evolving?
JJ: We are a participant in DARPA's Dialysis-Like Therapeutics
(DLT) team program. The goal of the DLT program is to create a sepsis treatment
device and then submit an IDE to the division of the Center for Devices and
Radiological Health at the FDA, as a means to initiate human clinical studies.
The DLT team has done tremendous work in advancing instrument designs, as well
as in discovering therapeutic biofiltration mechanisms that could be beneficial
in treating sepsis patients.
TLSR: Let's talk about finances. Aethlon was listed on NASDAQ
earlier this year, receiving a $6 million injection of capital. How do you plan
to use these funds?
JJ: The uplisting to NASDAQ was of significant importance as it
provides us with access to the broader capital markets going forward. The
proceeds are primarily directed toward clinical progression.
Based on the magnitude of the
underlying markets we are targeting, we believe that successful clinical
progression would drive stakeholder value and allow us to access the capital
markets in the future on a less dilutive basis, as compared to our options
prior to listing on NASDAQ.
TLSR: Why is your management team uniquely suited to take this
company forward?
JJ: We have evolved our technology from a theoretical concept
into early R&D studies, then into animal studies, and then into multiple
human studies, which now allows us the opportunity to work with the FDA to
clinically advance our vision in the United States. As our product is a
first-in-class therapy, our small team has an unrivaled understanding of our
technology and the industry space.
In fact, our capabilities to
selectively target disease-promoting factors from blood led to the launch of a
majority-owned subsidiary, Exosome Sciences Inc. Though not our core focus,
Exosome Sciences is working to expand the application of some of our affinity
binding techniques into the diagnostic field.
Our methods are being tested in the
Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests
(DETECT) study, which is managed by Boston University's Chronic Traumatic
Encephalopathy (CTE) Center. CTE is a chronic neurological condition associated
with sub-concussive blows to the head. It's best known from a media standpoint
for its prevalence in former NFL players.
Presently, CTE can only be diagnosed
postmortem, through autopsy. There is no blood-based test to identify the
disease. The Veterans Administration and our collaborators at Boston University
have identified CTE in 87 of 91 brains of former NFL players that were examined
post-autopsy.
The goal of the DETECT study is to
discover a biomarker that could identify CTE while people are alive. We have
discovered an exosome-based particle, which we call a Tausome, that we believe
correlates very closely with cognitive decline. In our initial studies, we have
observed that Tausome levels in former NFL players are significantly higher
than that of control subjects. A manuscript that details our findings is
pending publication.
TLSR: What can we expect from Aethlon near term, and five years
on?
JJ: In the near-term, we need to accelerate the pace of our IDE
feasibility study. We are now completing the transition of our study principal
investigator, as previously disclosed. We have also been quite busy in the interim,
as we have worked to improve the quality assurance, quality control, and
document control functions that underlie the manufacturing of our technology.
We have also been advancing methodologies through collaborations that should
allow for low-cost, large-scale production of the affinity lectin that we
immobilize within our Hemopurifier. We've been quietly building the internal
engine of the company.
Now we need to move forward on the
clinical side, and then leverage our outcomes into pivotal studies against
chronic viral pathogens, where it is feasible to conduct controlled clinical
studies. We will pursue humanitarian pathways for high-threat viral pathogens
that are not treatable with antiviral drug therapies.
Parallel to our viral endeavors, we
need to leverage our opportunity in the oncology space, which I believe is an
untapped value driver for our company long term.
Based on our novel device mechanism
and the size of underlying market opportunities, successful clinical
progression might also trigger the interest of large players in the infectious
disease and oncology fields.
TLSR: You just mentioned the importance of larger players. Are
you looking to perhaps license the technology, develop it yourself, or partner
with another company?
JJ: At this point in time, the Hemopurifier technology is
developed. We have a lot of clinical experience abroad that we're working to
replicate here in the U.S.
In terms of other development
opportunities, we eventually may want to partner with others to immobilize a
variety of affinity agents to advance selective extracorporeal cocktail
therapies to address unique yet hard-to-treat disease conditions.
As a medical device developer we
don't have the same overall clinical challenges as biologic drug developers, so
we're not forced to partner or license our technology to advance. What we
really need to focus on is clinically progressing our technology and showing
that it's not just safe, but also can provide patient benefit in large disease
conditions.
TLSR: Is there anything else that you'd like investors to know?
JJ: To summarize, we have an expansive therapeutic device
platform. Our lead product, the Hemopurifier, provides a clinical pathway into
both infectious disease and cancer. It has proven, broad-spectrum capabilities
against viral pathogens, and could be an untapped value driver based on the
discovery that our Hemopurifier can also capture cancer-promoting exosomes.
In terms of our DARPA DLT team, we
hope to have a sepsis treatment candidate ready for an IDE submission in the
coming year.
Then, on the diagnostic front, we
have a manuscript pending publication related to the first blood-based
biomarker candidate to identify and monitor CTE in living individuals.
TLSR: Jim, thank you very much.
James A. Joyce is the founder, chairman and CEO of Aethlon
Medical. Under his leadership, Aethlon has transformed the concept of a
selective therapeutic filtration device (the Aethlon Hemopurifier) into the
reality of treating patients in a clinical setting, with follow-on research
validating the ability of the Hemopurifier to capture a broad-spectrum of
bioterror and pandemic threats as well as immunosuppressive cancer exosomes.
Joyce has originated numerous collaborative relationships with government and
non-government research organizations, has authored supporting publications and
reports, and raised capital resources to support the mission of Aethlon Medical.
He has represented the company on CNN, NBC, ABC and other media outlets, and
has testified before Congress on issues related to Project BioShield
legislation and the deployment of the Aethlon Hemopurifier as a countermeasure
against biological weapons. In May 2011, the company introduced the Aethlon
ADAPT system, a device platform that converges affinity drug agents with plasma
membrane technology to create new candidate therapies against life-threatening
disease conditions. From February 1993 until founding Aethlon Medical, Joyce
was CEO of James Joyce & Associates. Previously, he was founder and CEO of
Mission Labs Inc., was a principal at London Zurich Securities 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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