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Tuesday, January 12, 2016

Aethlon Medical’s (Nasdaq: AEMD) ExosomeSciences to Participate in Clinical Research Study To Diagnose Chronic Traumatic Encephalopathy (CTE)

Aethlon Medical’s (Nasdaq: AEMD) ExosomeSciences to Participate in Clinical Research Study To Diagnose Chronic Traumatic Encephalopathy (CTE)



SAN DIEGO, CA, January 12, 2016 – Exosome Sciences, Inc., in collaboration with majority shareholder Aethlon Medical, Inc. (Nasdaq:AEMD), announced today that it has agreed to participate in a clinical research study to establish methods for detecting and diagnosing chronic traumatic encephalopathy (CTE) during life as well as examining risk factors for CTE. CTE is a disease of the brain often found in athletes, military veterans, and others with a history of repetitive head impacts. At present, CTE can only be definitively diagnosed through post-mortem examination of brain tissue.

The research study will be conducted under a $16 million grant that the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) has awarded to researchers from Boston University, the Cleveland Clinic, Banner Alzheimer’s Institute and Brigham and Women’s Hospital in Boston.  Overall, the project will involve a group of approximately 50 investigators, representing 17 research institutions.  Exosome Sciences has agreed to test an exosomal tau biomarker (TauSome™) that it has been advancing as a blood-based candidate to diagnose CTE.

“We are truly grateful that our colleagues at the Boston University CTE Center have expanded our opportunity to validate our Tausome™ biomarker as a candidate to detect and monitor CTE in living individuals,” stated Jim Joyce, Executive Chairman at Exosome Sciences and Chairman and CEO of Aethlon Medical.

Following its participation in the Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests (DETECT) study conducted by the Boston University CTE Center, Exosome Sciences also disclosed that it has agreed to provide follow-on TauSome™ testing to former NFL players who participated in that study.  The DETECT study was the first research project on CTE to be funded by the NIH, with support from NINDS, the National Institute on Aging (NIA), and the National Institute of Child Health and Human Development (NICHD).  The DETECT study enrolled former NFL players (ages 40-69) and same-age "control" athletes who played non-contact sports.  A manuscript which details TauSome™ (exosomal tau) data resulting from the DETECT study is pending publication. 


About CTE
Chronic Traumatic Encephalopathy (CTE) is a disease of the brain found in athletes, military veterans, and others with a history of repetitive head impacts. This type of trauma can trigger progressive degeneration of the brain tissue, including the build-up of an abnormal form of a protein called tau.  The brain degeneration is associated with memory loss, confusion, impaired judgment, impulse control problems, aggression, depression, and eventually progressive dementia.  A study recently conducted by the Department of Veterans Affairs and Boston University found CTE in 87 of 91 examined brains (post-mortem autopsy) of former NFL players.  At present, the diagnosis of CTE can only be made through post-mortem examination of brain tissue.


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 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.

Contacts:
Mike Smargiassi/Brad Edwards
Brainerd Communicators, Inc.
212-986-6667

James A. Joyce
Chairman and CEO
(Office) 858.459.7800 x301
(Cell) 619-368-2000

Jim Frakes
Chief Financial Officer
858.459.7800 x300

This news is published on the Investorideas.com Newswire - a global digital news source for investors and business leaders

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Wednesday, December 23, 2015

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.





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.

Want to read more Life Sciences Report interviews like this? Sign up for our free e-newsletter, and you'll learn when new articles have been published. To see recent interviews with industry analysts and commentators, visit our Streetwise Interviews page.

DISCLOSURE:
1) Gail Dutton conducted this interview for Streetwise Reports LLC, publisher of The Gold Report, The Energy Report and The Life Sciences Report, and provides services to Streetwise Reports as an independent contractor. She owns, or her family owns, shares of the company mentioned in this interview: None.
2) Aethlon Medical Inc. is a sponsor of Streetwise Reports.
3) James Joyce had final approval of the content and is wholly responsible for the validity of the statements. Opinions expressed are the opinions of James Joyce and not of Streetwise Reports or its officers.
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Tuesday, November 24, 2015

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Monday, November 23, 2015

Zacks Small Cap Research Maintains Buy Rating on Aethlon Medical (AEMD); Valued at $18 Share

Zacks Small Cap Research Maintains Buy Rating on Aethlon Medical (AEMD); Valued at $18 Share

Point Roberts WA, NEW YORK, NY – November 23, 2015 - Investorideas.com, a global digital news source covering leading sectors including biotech and medical technology reports new equity research on Aethlon Medical, Inc. (AEMD) was released by ZACKS SMALL CAP RESEARCH last week.  Analyst Brian Marckx, CFA maintains a buy rating with the following notes: 

“Current market discount rate, calculated by CAPM is approximately 9%.  Based on our DCF model and a 9% discount rate, AEMD is valued at approximately $18/share.  We are maintaining our Buy rating.  See below for access to our updated report on AEMD.  “

Operational Update:  Meets All 5 Objectives, Aethlon ADAPT, Additional Progress…

On the fiscal first quarter conference call in August management laid out five specific objectives that they planned to accomplish over the following months.  They successfully did so and went through each one on the Q2 call, which we have provided an update to below.  But in addition to meeting these goals the company also made parallel progress in not only further shoring up their operational capabilities in preparation for increased activities related to both the HCV and cancer applications but also made strides in broadening the scope of potential applications where their technology might be applied. 

A recap and update to the five objectives that the company laid out on the Q1 call in August….

- Collect an additional ~$200k under the DAPRA contract which relates to year 4.  Hope to be granted year 5 of the contract (which was subsequently awarded).  Accomplished with $186k collected in Q2 and DARPA year 5 awarded in September. 

- Submission of manuscript of the DETECT (Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests) study.  As a reminder, since late last calendar year Aethlon’s majority-owned subsidiary Exosome Sciences (ESI) has collaborated with Boston University’s CTE Center for the development of a blood-based diagnostic that would be able to identify CTE in living individuals.  ESI has used what they learned in how to isolate certain brain-specific biomarkers to evaluate blood samples collected by participants (former NFL players and a control group) enrolled in BU's DETECT study.  The study is the first on CTE funded by the NIH. Aethlon submitted the manuscript subsequent to the Q1 call.  Management noted on the Q2 call that they think it could be published within the next ~60 days.  As an aside, the night before AEMD’s earnings call there was a timely 60 Minutes story about BU’s CTE study and the blood-based diagnostic that AEMD’s Exosome Sciences is helping lead the development of. 

- Accelerate cancer study with University of California, Irvine.  As a reminder, in mid-April AMED announced that they entered an agreement with UC, Irvine to conduct an investigator-initiated study with various cancer types including breast, colorectal lung, head and neck and others.  Targeted enrollment is five patients in each of nine cancer types (45 patients total) including breast adenocarcinoma, colorectal, gastric and gastroesophageal, pancreatic, cholangiocarcinoma, lung, head and neck, melanoma and ovarian adenocarcinoma.  The proposed study protocol, Plasma Exosome Concentration in Cancer Patients Undergoing Treatment”, will monitor changes in circulating exosome levels and their association with cancer treatment and response to treatment.  In May AEMD announced that UC, Irvine Medical Center approved an IRB to commence the study.  AEMD noted on the Q2 call that this study has commenced and has now enrolled three patients so far.        

- Advance additional collaborations for Hemopurifier in cancer and infectious diseases.  As a reminder, Hemopurifier has shown potential utility in HCV, HIV, Ebola, other pandemic diseases, bioterror applications, cancer and other areas.  AEMD is clearly focused on deepening and broadening the potential applications that their device may have utility for.  In June the company announced an agreement with the India’s National Institute of Virology to commence testing of Hemopurifier for treatment of Chikungunya.  Management also noted on the Q2 call that they have initiated a research project with the National Center for Biodefense and Infectious Diseases to investigate the use of Hemopurifier in Venezuelan equine encephalitis.  AEMD has had a relationship with the National Center for Biodefense and Infectious Diseases for over ten years and this latest announcement appears to be further progress towards working with the center for applications of AEMD’s technology in addressing biological threats.  

- Initiate the U.S. HCV feasibility study and transition Dr. Stephen Fadem from principal investigator of the study to a medical advisory role within the company.  Subsequent to the Q1 call that transition was made and Dr. Ronal Ralph was brought on as the new principal investigator.  AEMD expects to hire two sub-principal investigators to help further accelerate the trial schedule.  And while progression of the study has been drawn out longer than initially anticipated, AEMD noted on the Q2 call that they expect to have the new study team trained after Thanksgiving and begin new patient enrollment in January.  


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About Aethlon Medical, Inc. (AEMD)
Aethlon Medical creates affinity biofiltration devices to treat life-threatening diseases. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a first-in-class device that targets the rapid elimination of infectious viruses and cancer-promoting exosomes from the circulatory system of treated individuals. U.S. clinical progression of Hemopurifier therapy is being advanced under an FDA approved clinical study. We also provide government contracting services to the Defense Advanced Research Projects Agency related to the development of a biofiltration device to treat sepsis. Additional information can be found online at www.AethlonMedical.com or you can connect with us on Twitter, LinkedIn, Facebook and Google+.


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Friday, October 30, 2015

Aethlon Medical's (NasdaqCM:AEMD) Biofiltration Platform Tackles Everything from Ebola to Cancer: CEO James Joyce

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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DISCLOSURE:
1) Gail Dutton conducted this interview for Streetwise Reports LLC, publisher of The Gold Report, The Energy Report and The Life Sciences Report, and provides services to Streetwise Reports as an independent contractor. She owns, or her family owns, shares of the company mentioned in this interview: None.
2) Aethlon Medical Inc. is a sponsor of Streetwise Reports.
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