SAN DIEGO, May 4, 2016 /PRNewswire/ -- Exosome Sciences, Inc., in collaboration with majority shareholder Aethlon Medical, Inc., (Nasdaq: AEMD) announced today that it will initiate production of its ELLSA™ (Enzyme Linked Lectin Specific Assay) diagnostic platform to isolate disease-specific exosomes from bodily fluids. Exosome Sciences, Inc. (ESI) will make the platform available to collaborative institutes that are conducting research on exosomal biomarkers with the eventual goal of supporting a new generation of diagnostic products.
Similar to an enzyme-linked immunosorbent assay (the basis of most modern medical diagnostic testing), the ELLSA is coated with an affinity capture lectin; the same lectin that is used in the Aethlon Hemopurifier®. The Hemopurifier® is a first-in-class broad-spectrum treatment countermeasure against life-threatening viral infections and also is being studied for its potential to address tumor-secreted exosomes that circulate in the bloodstream to spread metastasis and suppress the immune system of cancer patients.
Beyond its potential use as a companion diagnostic to support Hemopurifier therapy, ESI believes the ELLSA platform may appeal to collaborators who seek to isolate disease-specific exosomes as the basis for new diagnostic candidates. Prior to the formal launch of its ESI diagnostic subsidiary, Aethlon produced the ELLSA platform on a limited basis to support beta-testing research programs. Exosomal biomarkers have since emerged to become candidates to detect a broad-spectrum of diseases, including cancer, viral infections and neurological conditions. Exosomes transport disease origin RNA, DNA and proteins that can be isolated from the urine, blood components, saliva and most other bodily fluids.
Preliminary HIV Exosome Data
ESI also disclosed that an investigational study conducted by researchers at the Morehouse School of Medicine, demonstrated for the first time that urinary exosomes isolated from HIV-infected individuals contain HIV specific proteins that may serve as a potential diagnostic tool. In the study, the researchers utilized the ELLSA platform to isolate urinary exosomes followed by an antibody step to detect HIV-specific exosomes. The Morehouse team reported that the diagnostic protocol accurately identified HIV-specific exosomes in 111 HIV-infected individuals, but not in the urine of 35 HIV negative control subjects. The detection of HIV-specific exosomes in the urine could represent a simple noninvasive global strategy to diagnose HIV infection. Follow-on clinical studies are currently be evaluated.
Preliminary Chronic Traumatic Encephalopathy (CTE) TauSome Data
ESI recently disclosed the published preliminary results of the first candidate blood test to detect the neurodegenerative disease Chronic Traumatic Encephalopathy (CTE) in living individuals. CTE is associated with exposure to repetitive head impacts, such as those experienced by American football players, and at presents is only be diagnosed through post-mortem autopsy. The study outcomes were based on ESI's discovery of an exosome-based biomarker known as a TauSome(™).
In the study, researchers examined 78 former National Football League (NFL) players and a control group of 16 former non-contact sport athletes. All subjects were participants in a larger project that was funded by a grant from the National Institutes of Health to develop a variety of biomarkers for CTE conducted at Boston University School of Medicine. The study demonstrated that TauSome levels were approximately 9x higher on average in the NFL group as compared to the control group. Additionally, TauSome levels in the NFL group were significantly correlated with performance on standardized tests of memory and psychomotor speed. Meaning, the higher the TauSome level, the worse the study participant performed. A series of future TauSome studies have been planned, including the potential use of the ELLSA platform for TauSome isolation, as well as follow-on TauSome testing as part of a $16 million grant awarded to the Boston University team by the NIH to develop methods of diagnosing CTE during life.
About Aethlon Medical, Inc.
Aethlon Medical (Nasdaq: AEMD) creates affinity biofiltration devices to treat life-threatening diseases. The Aethlon Hemopurifier® is a leading broad-spectrum treatment countermeasure against infectious viral pathogens. The device, which has been successfully administered to individuals infected with HIV, Hepatitis C (HCV) and Ebola virus, is currently the subject of FDA approved clinical studies. Aethlon is also studying the potential use of the Hemopurifier® to address exosomes secreted by tumors to promote the spread of metastasis and suppress the immune system of cancer patients. The Company provides government contracting services to the Defense Advanced Research Projects Agency (DARPA) related to the development of a biofiltration device to treat sepsis and maintains majority ownership of Exosome Sciences, Inc., which is focused on the discovery of exosomal biomarkers to diagnose and monitor Chronic Traumatic Encephalopathy (CTE) and other neurological disorders. Additional information can be found online at www.AethlonMedical.com or you can connect with us on Twitter, LinkedIn, Facebook and Google+.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that may contribute to such differences include, without limitation, the Company's ability to maintain its listing on the Nasdaq Capital Market, or any other national securities exchange, that the Company or its subsidiary will not be able to commercialize its products, that the FDA will not approve the initiation or continuation of the Company's clinical programs or provide market clearance of the Company's products, including products developed by Exosome Sciences, Inc., 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, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in its contract with DARPA, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2015, and in the Company's other filings with the Securities and Exchange Commission. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
Mike Smargiassi/Brad Edwards
Brainerd Communicators, Inc
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SOURCE Aethlon Medical, Inc.