PHOENIX, Ariz. -- May 13, 2019 -- Aethlon Medical Inc. (AEMD) and its diagnostic subsidiary, Exosome Sciences, in collaboration with the Translational Genomics Research Institute (TGen) and the Prostate On-Site Project (POP), announced that Aethlon, TGen and POP will engage with participants for their studies of chronic traumatic encephalopathy (CTE) in living individuals during the 18th annual Jerry Colangelo Sports Legends Golf Classic in Phoenix.
Study participants will include former athletes who may have experienced repeated head impacts, such as former NFL players, as well as controls, those who played sports such as baseball that usually do not have significant head impacts. All participants will provide samples for analysis of potential biomarkers of CTE.
Aethlon aims to further validate TAUSOMETM, a CTE biomarker candidate, as an accurate and noninvasive biomarker for detection of CTE. Currently, CTE can only be diagnosed post-mortem. Aethlon's CTE studies are part of efforts to identify markers such as TAUSOMETM that will identify individuals currently living with CTE, as well as those at risk of developing CTE in their lifetimes.
TGen, an affiliate of City of Hope, will be looking for extracellular RNAs that may change as a result of head impact. These data will be incorporated with a series of studies on concussions and repetitive head impact exposure. Extracellular RNA changes are emerging as a new and sensitive tool to identify gene expression changes in the brain.
Aethlon was part of one of the first CTE research programs funded by the National Institutes of Health (NIH) -- The DETECT Study -- which previously studied the TAUSOMETM biomarker. The study examined 78 former NFL players and a control group of 16 former non-contact sport athletes. The study showed that TAUSOMETM levels were significantly elevated in the NFL group as compared to the control group. Notably, within the former NFL player group, higher TAUSOMETM plasma levels correlated with poorer performance on standardized tests of memory and psychomotor speed. These results were subsequently published in the Journal of Alzheimer's Disease.
"The Jerry Colangelo tournament is an ideal location to engage with high-profile former athletes," said Timothy C. Rodell, M.D., Interim Chief Executive Officer of Aethlon Medical. "Gene Felker, founder of POP and a prostate cancer survivor who was posthumously diagnosed with CTE, increased awareness among his fellow athletes of the importance of early detection of diseases such as prostate cancer and CTE. His daughter, Marla Felker Zimmerman, is carrying out his mission at the Jerry Colangelo Sports Legend Classic. Solomon Wilcots, our Players' Council leader, has collaborated with former athletes nationally with the goal of expanding the collection to additional sites across the U.S."
For more information about the project, details about the upcoming study collection and study coordinator contact information, please visit http://www.tgen.org/cte.
Separately, Aethlon announced that a patent covering its TAUSOMETM and other CTE biomarker-based intellectual property for detecting brain pathologies has issued in Europe. The European patent specifically covers devices and methods for diagnosing CTE and Alzheimer's disease using biomarkers such as TAUSOMETM, β-amyloid and others from saliva, urine, blood or plasma. The patent is effective in Denmark, France, Germany, Ireland, the Netherlands, Sweden, Switzerland, and the UK. Corresponding patent applications are pending in the United States.
About Aethlon Medical, Inc.
Aethlon Medical is focused on addressing unmet needs in global health. The Aethlon Hemopurifier® is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Company believes that the Hemopurifier® depletes the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis, and inhibit the benefit of leading cancer therapies. The Hemopurifier® is an FDA designated "Breakthrough Device" related to the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. The Hemopurifier also holds a Breakthrough Device designation related to life-threatening viruses that are not addressed with approved therapies.
Additionally, Aethlon owns 80% of Exosome Sciences, Inc., which is focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disease progression. Additional information can be found online at http://www.AethlonMedical.com and http://www.ExosomeSciences.com.
Forward Looking Statements
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," "should", "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 develop and commercialize the Hemopurifier, that the FDA will not approve the initiation or continuation of the Company's clinical programs or provide market clearance of the Hemopurifier, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, including any diagnostic products related to the detection of CTE, 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, 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 the 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, 2018, 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.
Chief Financial Officer
Aethlon Medical, Inc.
Russo Partners, LLC
About TGen, an affiliate of City of Hope
Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life-changing results. TGen is affiliated with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases: http://www.cityofhope.org. This precision medicine affiliation enables both institutes to complement each other in research and patient care, with City of Hope providing a significant clinical setting to advance scientific discoveries made by TGen. TGen is focused on helping patients with neurological disorders, cancer, diabetes and infectious diseases through cutting-edge translational research (the process of rapidly moving research toward patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and complex rare diseases in adults and children. Working with collaborators in the scientific and medical communities worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: http://www.tgen.org. Follow TGen on Facebook, LinkedIn and Twitter @TGen.
TGen Senior Science Writer