Aethlon Announces FDA Approval of IDE Supplement for COVID-19 PatientsPosted on June 19, 2020
Allows for enrollment of up to 40 subjects in up to 20 centers
SAN DIEGO, June 18, 2020 /PRNewswire/ — Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplement to the Company’s existing Investigational Device Exemption (IDE) for the Company’s Hemopurifier® in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19 in a new feasibility study.
The feasibility study, which is the device equivalent of a phase 1 trial, will enroll up to 40 subjects at up to 20 centers in the U.S. Subjects will have established laboratory diagnosis of COVID-19, be admitted to an intensive care unit (ICU) and will have acute lung injury and/or severe or life threatening disease among other criteria.
The Hemopurifier has previously been tested in patients with hepatitis C virus (HCV) infection and in one patient with Ebola virus infection. A laboratory version of the Hemopurifier has also been shown to clear multiple other viruses in vitro including a model version of the Middle Eastern Respiratory Syndrome (MERS) virus which is a coronavirus from the same family as the SARS-CoV-2 virus that causes COVID-19.
Timothy C. Rodell, M.D., Chief Executive Officer of Aethlon, stated, “We believe that the Hemopurifier may have the potential to help severely affected patients with COVID-19. We believe that clearing circulating virus in these patients, in combination with other supportive measures, could improve outcomes in this deadly disease.”
The Hemopurifier is an FDA designated “Breakthrough Device” for the treatment of life-threatening viruses that are not addressed with approved therapies. The Hemopurifier also holds a Breakthrough Device designation for 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.
About Aethlon Medical, Inc.
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.
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 enroll patients and to successfully complete the Early Feasibility Studies in viral diseases and cancer and achieve the endpoints for the study or any future studies with its Hemopurifier or to successfully develop and commercialize the Hemopurifier. 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.