Aethlon Announces FDA Approval of IDE Supplement for COVID-19 Patients

Rhea-AI Summary

Aethlon Medical (Nasdaq: AEMD) announced FDA approval for a supplement to its Investigational Device Exemption (IDE) enabling the Hemopurifier® to be tested in COVID-19 patients. The feasibility study will include up to 40 subjects in ICUs with acute lung injury and severe symptoms. The Hemopurifier, previously tested for hepatitis C and Ebola, is designated as a Breakthrough Device for life-threatening viral infections and advanced cancer. CEO Timothy C. Rodell believes the device could improve outcomes for severely affected COVID-19 patients.

Positive

• FDA approval for testing Hemopurifier in COVID-19 patients.
• Potential to improve outcomes for severely affected patients.
• Breakthrough Device designation enhances market potential.

Negative

• Approval is contingent on successful completion of feasibility studies.

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 -1%26h%3D2322983315%26u%3Dhttp%253A%252F%252Fwww.aethlonmedical.com%252F%26a%3Dwww.AethlonMedical.com&a=www.AethlonMedical.com" rel="nofollow">www.AethlonMedical.com and -1%26h%3D4056852732%26u%3Dhttp%253A%252F%252Fwww.exosomesciences.com%252F%26a%3Dwww.ExosomeSciences.com&a=www.ExosomeSciences.com" rel="nofollow">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.

Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc. 
858-459-7800 x3300
Jfrakes@aethlonmedical.com

Media Contact:
Tony Russo, Ph.D.
Russo Partners, LLC
tony.russo@russopartnersllc.com
212-845-4251

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com 
212-966-3650

View original content:http://www.prnewswire.com/news-releases/aethlon-announces-fda-approval-of-ide-supplement--for-covid-19-patients-301079557.html

SOURCE Aethlon Medical, Inc.

FAQ

What is the purpose of Aethlon Medical's Hemopurifier?

The Hemopurifier is designed to clear harmful viruses, including SARS-CoV-2, from the bloodstream.

When was the FDA approval for the Hemopurifier announced?

The FDA approval was announced on June 18, 2020.

What is the scope of the feasibility study for the Hemopurifier?

The study aims to enroll up to 40 patients in ICUs with severe COVID-19 symptoms across 20 centers.

What does Breakthrough Device designation mean for Aethlon Medical?

It signifies that the Hemopurifier addresses unmet medical needs and may expedite its development and review process.

What conditions must patients meet to participate in the Hemopurifier study?

Patients must have an established COVID-19 diagnosis and exhibit acute lung injury or severe disease.