SAN DIEGO, March 24, 2020 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in global health, announced today that it has received European Patent No. 1,993,600 ("the '600 Patent") entitled "Extracorporeal Removal of Microvesicular Particles." The '600 patent embodies Aethlon's Hemopurifier® technology designed for the depletion of immune suppressive, and potentially cancer-promoting, exosomes from the circulatory system.
Exosomes have been shown to participate in the development and advancement of cancer. Exosomes derived from tumor cells may promote immune suppression and seed the spread of metastasis. Notably, these tumor derived exosomes may also inhibit the activity of immuno-oncology drugs such as pembrolizumab (KEYTRUDA®). Tumor derived exosomes are not currently addressed with an approved therapy.
Aethlon has demonstrated the ability of laboratory versions of the Hemopurifier® to capture exosomes underlying several forms of cancer, including breast, ovarian and melanoma, in laboratory experiments. In November 2018, Aethlon received a "Breakthrough Device" designation from the U.S. Food and Drug Administration (FDA) to support the advancement of the Hemopurifier® for the treatment of cancer. In October 2019, the FDA approved Aethlon's Investigational Device Exemption (IDE) application to initiate an Early Feasibility Study (EFS) of the Hemopurifier® in patients with advanced head and neck cancer in combination with standard of care KEYTRUDA®. This EFS, which is the device equivalent of a phase 1 trial, will be a small single center, open label trial in 10 to 12 subjects.
"By reducing the presence of tumor-derived exosomes from the circulatory system of cancer patients, we believe the Aethlon Hemopurifier® could have the potential to improve the benefits of existing cancer treatment regimens and emerging immuno-oncology drugs," stated Timothy C. Rodell, M.D., Aethlon's CEO. "This issued European patent, along with corresponding issued patents in the United States and Canada, are critical for Aethlon's plans to develop the Hemopurifier® for applications in oncology around the world."
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 Hemopurifier also holds a Breakthrough Device designation related to life-threatening viruses that are not addressed with approved therapies.
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 Early Feasibility Study and future studies with its Hemopurifier or 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.
S.A. Noonan Communications, LLC
212 966 3650
Chief Financial Officer
Aethlon Medical, Inc.
SOURCE Aethlon Medical, Inc.