The Life Science Report: What triggered Aethlon Medical Inc. (AEMD:NASDAQ), through its subsidiary Exosome Sciences, to pursue the discovery of a biomarker that could identify chronic traumatic encephalopathy (CTE) in living individuals?
Jim Joyce: While we may be best known for our broad-spectrum therapeutic platform, our CTE-related research was triggered by the death of a former friend and teammate, who was the second person diagnosed with CTE by our colleagues at the Boston University CTE Center. This factor, and the reality that there was no way to identify CTE in the living, inspired us to take on the challenge of solving this problem.
Based on our research history and knowledge of disease-released exosomes, we thought it might be possible to identify an exosomal biomarker that could cross the blood-brain barrier with cargo that could help identify and potentially monitor neurological disease conditions. We translated our belief into the discovery of an exosomal biomarker that we call a TauSome™. In addition to CTE, we believe circulating TauSome levels could emerge as candidates to monitor other neurological disorders, such as Alzheimer's disease.
Our Exosome Sciences subsidiary has also been advancing exosome-based strategies to diagnose and monitor infectious viral pathogens and oncology indications, which are high priority therapeutic targets for Aethlon Medical.
TLSR: Can you share the CTE-related TauSome clinical data that you have collected so far?
JJ: Sure. In a study of 78 former NFL players and 16 control subjects who participated in sports that did not involve head trauma, we observed that TauSome blood plasma levels were 9x higher on average in the NFL group as compared to the control subjects.
"We plan to leverage our compelling initial observations to conduct various studies that may further validate our TauSome biomarker."
Additionally, we observed a remarkable correlation between TauSome levels and cognitive decline, meaning that higher TauSome levels were associated with greater cognitive decline based on memory and psychomotor tests administered to study subjects. Our results have now been published in the Journal of Alzheimer's Disease.
TLSR: What are the next steps specific to TauSome clinical programs?
JJ: We plan to leverage our compelling initial observations to conduct various studies that may further validate our TauSome biomarker. This includes follow-on TauSome testing in a $16 million National Institutes of Health (NIH) grant program that will enroll former NFL players at up to 17 different clinical sites.
TLSR: Can you describe how your TauSome biomarker may impact the NFL and other sports where head trauma may occur?
JJ: For the NFL and other high-impact sports franchises, a test that could measure baseline TauSome levels, and then monitor changes in TauSome levels, might assist in protecting participants from disease progression, and at the same time play an critical role in managing legal liability.
In reality, the NFL receives far too much blame for CTE problem, as many players suffered repetitive head trauma for more than a decade prior to entering the NFL through participation in football at the Pop Warner, high school and college levels. Beyond the implications of protecting athletes and reducing liability, a test that could diagnose and monitor CTE in living individuals would open the door for the first candidate CTE therapies to be tested.
TLSR: Thank you, Jim.
Jim Joyce is the founder of Exosome Sciences and founder, chairman and CEO of Aethlon Medical Inc., 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.
1) Tracy Salcedo compiled this interview for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She owns, or her family owns, shares of the following companies mentioned in this interview: None.
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