SAN DIEGO, Aug. 6, 2020 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in oncology and viral diseases announced today that the National Institute for Dental and Craniofacial Research (NIDCR), a unit of the National Institutes for Health (NIH), has awarded a grant for studies in head and neck cancer that will be a collaborative project between Aethlon and the UPMC Hillman Cancer Center at the University of Pittsburgh.
The grant, entitled "Depleting exosomes to improve responses to immune therapy in head and neck squamous cell carcinoma" will profile the biomarkers of exosomes in patients with recurrent and metastatic head and neck cancer and will explore the impact of clinical depletion of exosomes using Aethlon's proprietary Hemopurifier device. Exosomes are nanosized particles that are released in large quantities from cancer cells and carry the complement of a tumor's genetic and protein cargo, which endows them with the capacity to fuel cancer growth and immune suppression. The Hemopurifier is being advanced as a potential therapeutic device for oncology by virtue of its capacity to capture and remove exosomes from plasma.
The total value of the award is $3.5 million over five years for multi-institution studies that will be led by Drs. Theresa Whiteside at UPMC and Annette Marleau at Aethlon as Principal Investigators. The funds will be primarily allocated to UPMC and two other participating academic institutions that will apply their expertise in immuno-oncology to programs that could accelerate the clinical advancement of the Hemopurifier.
"We are delighted to have the opportunity to work with Dr. Whiteside, a leading researcher in the area of tumor-derived exosomes, and the multidisciplinary team that has been assembled to evaluate the effects of exosomes in head and neck cancer," stated Timothy C. Rodell, M.D., CEO of Aethlon Medical. "Head and neck cancer continues to have a poor prognosis due to disease recurrence and the development of metastatic disease. We believe that the real value of this grant for Aethlon is that this work will provide insights into the potential clinical benefits of depleting circulating exosomes using the Hemopurifier for improving the responses of patients to the standard immunotherapy treatments."
"We are appreciative of the funding from NIDCR for this investigation of the roles of exosomes in head and neck cancer," stated Theresa Whiteside, Ph.D., Principal Investigator and Professor of Pathology, Immunology and Otolaryngology at UPMC. "Exosomes have emerged as major contributors to tumor-associated immune suppression and as significant barriers to cancer therapies. The overarching objective of this work will be to advance therapeutic capabilities and novel exosome-based predictive tools for head and neck cancer."
About Aethlon Medical, Inc. and the Hemopurifier®
Aethlon Medical, Inc. is focused on addressing unmet needs in global health. The Aethlon Hemopurifier is a clinical-stage device designed to combat cancer and life-threatening viral infections.
In preclinical studies in cancer, the Hemopurifier depletes the presence of circulating tumor-derived exosomes that are believed to promote immune suppression. These tumor derived exosomes also appear to seed the spread of metastases and therefore may 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 cancer. The FDA has approved an Investigational Device Exemption (IDE) application to initiate an Early Feasibility Study (EFS) of the Hemopurifier® in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda). The Hemopurifier also is an FDA designated "Breakthrough Device" related to life-threatening viruses that are not addressed with approved therapies. The FDA also has approved a supplement to the Company's existing IDE to allow for the testing of the Hemopurifier® in patients with SARS-CoV-2/COVID-19 in a new feasibility study.
Aethlon also 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 www.AethlonMedical.com and 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," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially," "appear" 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, Aethlon Medical, Inc.'s (the Company) ability to successfully complete the grant for studies in head and neck cancer with the UPMC Hillman Cancer Center at the University of Pittsburgh, or to successfully complete the Early Feasibility Studies in head and neck cancer or in COVID-19, Aethlon's ability to demonstrate that the removal of exosomes with the Hemopurifier will result in better outcomes for the treatment of cancer, and Aethlon's ability to successfully develop and commercialize the Hemopurifier, its ability to raise additional funds and other risks. 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, 2019, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. 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.
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Aethlon Medical, Inc.
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SOURCE Aethlon Medical, Inc.