March 19, 2014
Aethlon Medical, Inc., and its diagnostic subsidiary, Exosome Sciences, Inc. (ESI), announced today that researchers have isolated brain-derived exosomes released into the bloodstream from aggressive brain tumors. Through the use of proprietary size exclusion/lectin/antibody-capture techniques, the Aethlon-ESI research team was able to identify, quantify, and characterize circulating Glioblastoma multiforme (GBM) exosomes, which hold promise as both a disease biomarker and therapeutic target as GBM exosomes are shed into the circulatory system to promote tumor growth and stimulate angiogenesis.
“Building on our proprietary method to identify, quantitate and characterize brain-derived exosomes, we now have the ability to detect this aggressive cancer early and aid in its treatment,” stated ESI Chief Scientific Officer, Dr. Douglas Taylor.
Aethlon Medical develops therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions. The Aethlon Hemopurifier® is a first in class medical device that addresses a broad-spectrum of viral pathogens as well as tumor-secreted exosomes that promote cancer progression and suppress the immune system of cancer patients. Aethlon is currently preparing to launch the first FDA approved clinical study of Hemopurifier® therapy in the United States. ESI was established by Aethlon to develop non-invasive exosome-based “liquid biopsies” that diagnose and monitor acute and chronic disease conditions.
GBM represents the most common, per capita costly and uniformly lethal primary brain tumor. GBM comprise 23% of primary brain tumors in the US and is the most commonly diagnosed brain tumor in adults aged 45-74 with men being more frequently diagnosed than women. The prognosis remains poor despite aggressive treatment modalities. Over the past decade, a median survival time of 12 months has only been marginally improved to 14.6 months as a result of advances in chemo/radiation and the use of molecularly targeted agents. Beyond being a candidate target for Hemopurifier® therapy, the discovery of circulating GBM-exosomes offers a potential new paradigm in GBM clinical management through a platform technology to predict tumor regression or progression.
“The ability to characterize disease specific exosomes in circulation will enable improved diagnosis to identify type and grade of these most challenging of brain tumors and may additionally help to advance novel treatment strategies,” stated Dr. Cicek Gercel-Taylor, Clinical Research Director at ESI.
To date, there have been two critical barriers to successful GBM treatment. First, there currently is no method for evaluating the dynamic changes in GBM during therapy. Standard imaging approaches do not provide metrics of tumor-specific genetic/phenotypic changes and operative information is expensive, potentially morbid and limited by errors in topographic sampling. Second, clinicians, lacking tumor-specific parameters, are unable to effectively monitor responses to therapy over short time frames. These limitations are derived from the difficulty in obtaining repeated biopsies of tumor tissue, and the confounding effects on tumor MRI of necrosis, inflammation, surgical artifact and edema. Additionally, the appearance of GBM by current imaging techniques is not specific, since other lesions such as abscess, metastasis, and other entities may have a similar appearance. As a result, clinicians have not been able to adequately evaluate therapeutic agents designed to target GBM. The objective of the Aethlon-ESI team is to extend and improve GBM patient quality of life by resolving the clinical challenges of monitoring patient response to both established and candidate therapies.
Earlier this month, the Aethlon-ESI research team disclosed that it was also to isolate brain-specific biomarkers that could have implications in the diagnosis, monitoring and treatment of Alzheimer’s Disease (AD), Chronic Traumatic Encephalopathy (CTE) and Traumatic Brain Injury (TBI). 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.
Find the press release here.