Aethlon Medical Announces Publication of Peer-Reviewed Journal Article Describing Hemopurifier Resin Binding of Seven COVID-19 Variants

Rhea-AI Summary

Aethlon Medical (AEMD) announced a peer-reviewed article published in PLOS ONE, showcasing that its GNA affinity resin in the Hemopurifier effectively captures seven SARS-CoV-2 variants, with efficacy ranging from 53% to 89%. CEO Charles J. Fisher emphasized the potential of the Hemopurifier in addressing emerging COVID-19 variants. The company is currently conducting an Early Feasibility Study involving 40 severe COVID-19 patients, and recently received FDA protocol amendment approval to eliminate prior dialysis treatment, which may expedite patient enrollment.

Positive

• Publication of data demonstrating Hemopurifier's ability to capture multiple SARS-CoV-2 variants.
• Potential for accelerated patient enrollment in clinical trials following FDA protocol amendment.
• Demonstrated efficacy of Hemopurifier in removing life-threatening viruses from blood.

Negative

• None.

SAN DIEGO, July 28, 2022 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, today announced the publication of a peer-reviewed journal article in PLOS ONE. The article, titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus nivalis Agglutinin," contains data demonstrating that the proprietary GNA affinity resin of the Aethlon Hemopurifier® efficiently captures seven clinically relevant variants of the SARS-CoV-2 virus responsible for the COVID-19 pandemic. Viral capture efficiency ranged from 53% to 89% for the variants tested.

"These data demonstrate that the Hemopurifier can effectively capture a wide range of clinically relevant SARS-CoV-2 variants," said Charles J. Fisher, M.D., Chief Executive Officer of Aethlon Medical. "As new variants and subvariants of this virus continue to emerge and induce new waves of the pandemic, health systems need innovative technologies that are agnostic to viral variations. The Hemopurifier may represent an opportunity to overcome this challenge and provide treatment to patients with severe COVID-19."

The Aethlon Hemopurifier, a clinical stage product candidate, is a therapeutic blood filtration system that has been demonstrated to bind and remove life-threatening viruses and harmful exosomes from blood. Aethlon currently is evaluating the safety and feasibility of the Hemopurifier in an active Early Feasibility Study (EFS), analogous to a Phase 1 clinical trial for a drug or biologic, which is designed to enroll up to 40 severe COVID-19 patients [NCT04595903]. The first patient in the study completed Hemopurifier treatment in the trial and nine hospitals are actively screening patients. Aethlon recently announced that the U.S. Food and Drug Administration (FDA) accepted a protocol amendment to the study, notably eliminating the requirement of previous dialysis treatment, which will potentially enable accelerated enrollment in the ongoing study.

The newly published article can be found here: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0272377.

About Aethlon and the Hemopurifier®

Aethlon Medical is a medical therapeutic company developing the Hemopurifier, a therapeutic blood filtration system indicated for infectious diseases and cancer. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and harmful exosomes from blood utilizing a proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases.

The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated 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. Under an Investigational Device Exemption (IDE) application, the FDA approved a single site, open-label Early Feasibility Study (EFS) to evaluate the Hemopurifier for reducing cancer-associated exosomes prior to the administration of standard-of-care pembrolizumab (KEYTRUDA®) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The EFS is being conducted at the University of Pittsburgh Medical Center Hillman Cancer Center.

The Hemopurifier also holds an FDA Breakthrough Device designation and an open IDE application related to the treatment of life-threatening viruses that are not addressed with approved therapies. A recent amendment to the IDE enabled Aethlon to implement a new EFS protocol to treat up to 40 COVID-19 patients at up to 20 clinical sites in the U.S.  In two case studies of patients treated under Emergency Use (EU), the Hemopurifier demonstrated binding of SARS-CoV-2 spike protein and removal of SARS-CoV-2 virus from the circulation of a human patient.

Additional information can be found at www.AethlonMedical.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" 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. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to enroll the Company's ability to enroll patients in and successfully complete its trials in COVID-19 patients and in its head and neck cancer trials, the Company's ability to successfully treat patients under any Emergency Use pathway, the Company's ability to enroll additional patients as a result of the recent protocol amendment, the Company's ability to enroll additional sites for its clinical trials, , the Company's ability to successfully complete development of its Hemopurifier, the Company's ability to raise additional funds, the Company's ability to expand its clinical trials into other areas of cancer, and other potential 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, 2022, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. 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.
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

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SOURCE Aethlon Medical, Inc.

FAQ

What recent publication did Aethlon Medical release regarding its Hemopurifier?

Aethlon Medical published a peer-reviewed article in PLOS ONE detailing the efficacy of its Hemopurifier in capturing seven clinically relevant SARS-CoV-2 variants.

What is the efficacy range of the Hemopurifier against SARS-CoV-2 variants?

The Hemopurifier demonstrated a viral capture efficiency ranging from 53% to 89% for the tested SARS-CoV-2 variants.

What is the current status of Aethlon Medical's clinical trials for COVID-19?

Aethlon Medical is conducting an Early Feasibility Study involving 40 severe COVID-19 patients, with the first patient already treated.

How has the FDA impacted Aethlon Medical's clinical trial protocols?

The FDA accepted a protocol amendment that removes the requirement for previous dialysis treatment, potentially speeding up patient enrollment in the ongoing study.