Aethlon Medical and Exosome Sciences Expand Brain Research Discoveries to Include Isolation of Glioblastoma Biomarker and Therapeutic Target
SAN DIEGO, March 19, 2014 /PRNewswire/ -- Aethlon Medical, Inc. (OTCQX:AEMD), 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.
About Aethlon Medical, Inc.
Aethlon Medical creates innovative medical devices to address life-threatening diseases. The Aethlon ADAPT™ (Adaptive Dialysis-like Affinity Platform Technology) establishes the basis for a new class of therapeutics that target the rapid elimination of disease enabling particles from the circulatory system of treated patients. The lead Aethlon ADAPT™ product is the Hemopurifier®, a device that addresses a broad-spectrum of viral pathogens as well as tumor-secreted exosomes that suppress the immune system of cancer patients. Aethlon is also operating under two government contracts with the Defense Advanced Research Projects Agency (DARPA) related the development of a medical device to reduce the incidence of sepsis. Exosome Sciences, Inc. is a majority owned Aethlon subsidiary that is advancing exosome-based strategies to diagnose and monitor cancer and infectious disease progression. Additional information can be found at www.AethlonMedical.com.
About Exosome Sciences, Inc.
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. Our candidate products are focused toward diagnostic advancements in the fields of oncology, infectious disease and brain injury. Exosomes represent an optimal diagnostic target as diseased or injured cells release these particles into body fluids such as urine, blood, saliva and cerebrospinal fluid where they can be accessed for analysis. Our exosome-based assays unlock the ability to identify proteomic and genomic alterations underlying a wide-range of pathologies, thus allowing for the introduction of novel non-invasive "liquid biopsies". Additional information can be found at www.ExosomeSciences.com.
Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that the ESI will not be able to commercialize its future products, that the FDA will not approve the initiation of the Company's existing or future clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy, 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 and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in the DARPA contract, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
James A. Joyce
SOURCE Aethlon Medical, Inc.
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