Jim Joyce, CEO and Chairman of Aethlon Medical, Inc., talks about new developments and research into CTE.
Interview conducted by Ivanhoe Broadcast News in May 2017.
Tell me a little bit about this study, you have a personal interest in it?
Joyce: Yes, while our core focus at Aethlon Medical has been to protect citizens against bioterror and pandemic threats, our CTE research was inspired by the death of Tom McHale, who was a former teammate. Tom played eight years in the NFL and was the second person diagnosed with CTE by the Boston University CTE Center in 2009. Tom was an interesting case because he never had a diagnosed concussion during his career. This factor contributed to researchers belief that CTE might be associated with repetitive sub-concussive blows to the head. Since Tom’s death, the BU CTE team has diagnosed CTE in 110 of the 111 brains of former NFL players that they examined after death. We have been advancing a test that we hope will unlock the ability to diagnose CTE while players are still alive.
Another study started, a Boston University study, is that right?
Joyce: Yes, we had the opportunity to participate in the first NIH funded study to learn about CTE. We were invited by the BU team to investigate a candidate blood-based CTE biomarker that was discovered by our research team. We call this biomarker a TauSome and have found that its levels are extremely elevated in former NFL players as compared to control subjects who participated in sports that didn’t involve repetitive head trauma.
What do you hope to do with this information?
Joyce: Well, right now we are preparing to kick off a follow-on study, which could become the largest CTE related study in former NFL players. We want to expand on the preliminary data we’ve already collected and reinforce it to the extent where our TauSome biomarker could be validated to diagnose and monitor CTE in living individuals. At present the disease is solely diagnosed at autopsy and until there is a means to diagnose and monitor CTE in the living, it’s not possible to advance candidate therapies.
If you could diagnose that somebody might have CTE, then what?
Joyce. Once we can diagnose CTE in the living, we can then investigate to potential benefit of therapies that might be tested in those who are at a high risk of suffering from CTE disease progression. Therapies that are being advanced in other types of neurological disorders such as Alzheimer’s, which also involves an abnormal plaguing of Tau protein in the brain, should be tested for benefit against CTE. We have already observed that TauSome levels in NFL subjects often correlates with that of Alzheimer’s patients, which could become a basis to quality former players for participation in anti-tau drug studies. If we can continue to validate our observations to date, we might be able to cut five to ten years off the timeline to qualify former players to receive these therapies. We are also investigating whether our TauSome biomarker might also be a therapeutic target that contributes to the progression of CTE and other tauopathies.
There are lots of folks out there that have no experience, no relationship with any kind of contact sport, but have Alzheimer’s in their family. It’s interesting how the research might help each other.
Joyce: I think it is critically important to associate what has been learned in Alzheimer’s disease and apply such knowledge to CTE. Alzheimer’s disease was discovered in 1906 and there have been tens of thousands of researchers and billions of dollars spent trying to unravel this disease, whereas in CTE we only have a handful of research institutes working to advance our understanding of the disease. While CTE recieves a lot of media attention, the disease is not well-understood. We need to look for clues from well-studied diseases such as Alzheimer’s, and apply our knowledge to advancing solutions for CTE.
As a former player, the prospect of being out there and watching colleagues and teammates developing problems with that must be pretty scary.
Joyce: It’s hard. Most guys that I speak with are doing fine, but because I did play football, I also hear from former players that aren’t doing so well. In some unfortunate cases, there are individuals who are isolating themselves from family and society as they know they have a neurological problem.
Do you have that fear for yourself at all, is that a personal concern as well?
Joyce: Quite honestly, we are so entrenched in our scientific endeavors that it is not something I dwell on. Especially, as there is still so much that we still need to learn about CTE.
If you are able to pinpoint this Tau and are able to track this it would be a gigantic step for moms of high school kids who are playing football or college kid, for everybody not just former NFL players?
Joyce: Our hope is that a well-validated biomarker would allow clinicians to look at biomarker levels to help determine who should or shouldn’t be participating in a sport. Not just at the juvenile level but at every level. At the NFL level, it would be immensely helpful to know baseline levels of a biomarker in players and then monitor changes in biomarker levels that might flag a health concern.
So potentially some day would it be a screener for a kid to play or not to play football?
Joyce: It’s too early to say, but I would agree that for someone not to play football today, we would have to understand the genetic blueprint for that individual. Somebody that’s playing these sports and also might have a history of Alzheimer’s or other neurological conditions in their family. In reality, it will be a multitude of pieces of information that will come forward in the future to help people make better decisions.
Tell me a little bit about the collaboration with Dr. Jensen, how does she fit in?
Joyce: The collaboration really has been wonderful so far. Dr. Jensen and her team at TGEN provide a level of expertise that is very much appreciated, and an open type of research participation that recognizes we need to establish clinical locations around the country to optimize our ability to collect the data to validate our biomarker and explore potential therapeutic candidates.
She was talking about some kind of an RNA marker, is that different than the TauSome marker you were talking about?
Joyce: No, it’s the same TauSome marker. However, the TGEN team is also going to analyze RNA cargos that are transported within the TauSome. Such information could contribute to understanding more about the origin of the disease or the mechanisms that drive the unhealthy aggregation of tau protein in the brain. These are questions that need to be answered. What we do know today is that former NFL players as compared to control subjects, had nine times higher levels of TauSome’s in their blood as compared to control subjects who were athletes that participated in sports that didn’t involve repetitive head trauma. Then also parallel to that, each of the NFL subjects participated in a series of psychomotor and memory tests that rated them for cognitive decline. In general, higher TauSome levels also correlated with worse performance in these cognitive decline tests.
You’re not actually measuring Tau you’re measuring the carrier that’s carrying it around the blood stream which is why you don’t have to do PET scans?
Joyce: That’s right. This is really crucial because there was initial research trying to observe Tau protein itself in the circulatory system. However, free tau is fleeting in the blood and very hard to distinguish whether its origin was indeed associated with a brain disease such as CTE. It’s like trying to find a needle in a haystack. If you’re trying to diagnose a disease, you hope to find a biomarker that can be found sufficient quantities, where you can quantitate changes in the levels as a means to monitor disease progression or response to therapies. If somebody is being administered a therapy and you see the levels go down, that may be an indicator that they are benefitting from the therapy. In the case of TauSome’s, they are very stable and can be found in remarkably high levels in the circulatory system.
And they are the transporters not the Tau?
Joyce: That’s correct, they’re exosomal particles that are transporting Tau protein. Part of the purpose of our study is to demonstrate that the tau being transported by Tausomes is indeed disease related. The exosomal biomarker field has been rapidly emerging in recent years because of its potential to diagnose and monitor a wide range of disease conditions. In infectious disease, we have isolated exosomes that transport viral RNA, which is the machinery required for viruses to replicate. In cancer, exosomes have emerged to become both biomarkers and therapeutic targets, based on their involvement in spreading metastases, which accounts for about 90 percent of cancer deaths.
What haven’t I asked you about the study that you think should be included?
Joyce: Beyond the clinical aspects of our study, its important is to recognize the people who are critical in determining the success of our studies. In this case its former NFL players who have a high risk suffering from CTE in the future. Myself and every other individual who played in the NFL knows of a former teammate who has suffered from the symptoms of a serious neurological disorder, whether it’s CTE or something else. Former players who are enrolling in our study are stepping back onto the field of play to potentially help themselves and a future generation of football players.
Have you started enrolling yet?
Joyce: We are now preparing to kick off the study. The study protocol has been designed and we are now awaiting final approval to initiate enrollment.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Jim Joyce
619-368-2000
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