Aethlon Medical, Inc., and its diagnostic subsidiary, Exosome Sciences, Inc. (ESI), announced that its researchers have successfully isolated brain-specific biomarkers associated with a variety of neurodegenerative disorders. The discoveries could have implications in the diagnosis, monitoring and treatment of Alzheimer's Disease (AD), Chronic Traumatic Encephalopathy (CTE) and Traumatic Brain Injury (TBI).  

Aethlon Medical develops therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions.  ESI develops exosome-based solutions to diagnose and monitor acute and chronic conditions.

The research studies provided evidence that exosomes can serve as a "liquid biopsy" to diagnose neurologic conditions. While exosomes from the central nervous system have previously been identified in the cerebrospinal fluid, the Aethlon-ESI study identified exosomes carrying brain-specific markers tau, beta-amyloid, glycoprotein A2B5 and S100B protein in the peripheral circulation of affected individuals. The discoveries provide a basis for an exosome-based platform that could enable the simultaneous identification of multiple brain specific markers that are transported across the blood-brain barrier and into the circulatory system.

CTE is a progressive degenerative disease, which at present can only be definitively diagnosed postmortem.  CTE has been most commonly found at autopsy in former professional football players and has also been demonstrated to be prevalent in soldiers exposed to blast injury.  The hallmark of CTE is the accumulation of tau, an abnormal protein that strangles brains cells in areas that control memory, emotions and other functions.  TBI or repetitive brain trauma, including concussions and sub-concussive blows to the head contribute to the onset of CTE.

AD is the most common form of dementia.  There is no cure for the disease, which worsens as it progresses, and eventually leads to death.  Beta-amyloid plaques and neurofibrillary tangles have long been recognized as a common pathologic hallmark of AD.  In 2010, it was estimated that 36 million people worldwide were living with AD.

"This advancement represents a new paradigm for brain injuries.  In addition to providing definitive diagnosis, the proteomic and transcriptomic characterization of exosomes isolated specifically from the brain will provide a window into the molecular mechanisms underlying acute and chronic brain injuries," stated ESI Chief Scientific Officer, Dr. Douglas Taylor.

As a result of the discoveries, brain-derived exosomes can be specifically isolated and the protein and RNA cargoes identified.  In studies of brain tissue, specific RNAs have been associated with development of neurological disorders, contributing to the onset and progression of brain injuries. Exosomal RNA and protein cargoes represent surrogates to brain biopsies and have utility as stable, clinically accessible biomarkers for brain injury detection, stratification of patients and therapeutic outcomes.

"With the exosome-based technologies developed by our group, we are at the verge of breakthroughs for the management and treatment of brain injuries and diseases that have been associated with disability and death," stated Dr. Cicek Gercel-Taylor, Clinical Research Director at ESI.

Circulating biomarkers have been proposed for the definitive diagnosis and monitoring treatment of brain injuries.  The approach would enable diagnosing the condition, identifying processes that are difficult to image, monitoring responses to interventions, and predicting those who are at risk for long-term neurologic consequences.  However, circulating biomarkers such as free protein and nucleic acids are extremely unstable in circulation, thus a high steady-state must be reached for detection, which is generally not observed except in severe cases. To circumvent these issues, exosome-associated biomarkers can be utilized as they are stable and detectable in the circulation.

"An exosome-based liquid biopsy that could identify the early onset of Alzheimer's disease or CTE in a living person may also unlock the ability to monitor disease progression and set the stage for new therapeutic advances, which could include Aethlon Medical therapeutic devices," stated Jim Joyce, CEO of Aethlon Medical and Executive Chairman at Exosome Sciences.    

The development of a therapeutic device that targets selective elimination of circulating beta-amyloid and tau is supported by the "peripheral sink" theory, which postulates that the reduction of these particles from systemic circulation promotes deplaquing from the brain. Thus, inhibiting the continued progression of neurodegenerative processes. Aethlon and ESI further disclosed the subsequent filing of a provisional patent entitled, "Brain Specific Exosome Based Diagnostics and Extracorporeal Therapies."

Aethlon Medical creates innovative medical devices to address life-threatening diseases.

Exosome Sciences (ESI), a majority wholly owned subsidiary of Aethlon Medical, Inc., develops exosome-based solutions to improve identification and monitoring of acute and chronic conditions.