Aethlon Medical Publishes In Vitro Studies Demonstrating Hemopurifier Resin Binding of Seven Clinically Relevant COVID-19 Variants
- Viral capture efficiency ranged from 53% to 89% for the seven COVID-19 variants tested
SAN DIEGO, May 2, 2022 -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical technology company focused on developing products to diagnose and treat life and organ threatening diseases, today announced the publication of a pre-print manuscript featuring data that demonstrated Aethlon's proprietary GNA affinity resin was able to bind seven clinically relevant SARS-CoV-2 variants in vitro, including the Delta and Omicron variants. Viral capture efficiency with the GNA affinity resin ranged from 53% to 89% for all variants tested. The GNA affinity resin is a key component of the Aethlon Hemopurifier®. The manuscript is titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus nivalis Agglutinin" and was published in bioRxiv. A link to the article follows: https://www.biorxiv.org/content/10.1101/2022.04.27.489436v1.
The Coronavirus-19 (COVID-19) pandemic, caused by the SARS-CoV-2 virus, has now exceeded two years in duration. The pandemic has been characterized by a succession of variants containing mutations to the spike protein, affecting the infectiousness and virulence of the virus and the efficacy of vaccines and monoclonal antibody therapies. Resistance to vaccination and limitations in the current available treatments require the ongoing development of therapies, especially for those with severe disease.
The Aethlon Hemopurifier® is an investigational immunotherapeutic device that is designed to remove viruses and exosomes from the blood. In this in vitro study, known concentrations of seven clinically relevant SARS-CoV-2 variants were passed three times over columns containing one gram of GNA affinity resin. Percent decrease in viral titer was compared with a control sample. Viral capture efficiency with the GNA affinity resin ranged from 53% to 89% for all variants tested. Extrapolation of these data would indicate that the binding capacity of the Aethlon Hemopurifier for viral loads observed in adult patients with severe COVID-19 infection would be more than sufficient.
"The COVID-19 pandemic has affected the world over, prompting the need for innovative treatment approaches. We believe that the Hemopurifier® is such an innovation and the findings in this study support our belief that our technology will likely remain active against future COVID-19 variants that affect the efficacy of vaccines and treatments," said Charles J. Fisher, Jr., M.D., CEO of Aethlon Medical and an author of the manuscript.
The safety and feasibility of the Aethlon Hemopurifier® is being evaluated in an active Early Feasibility Study, analogous to a Phase 1 clinical trial for a drug or biologic, that is designed to enroll up to 40 COVID-19 ICU patients [NCT04595903]. The pre-print manuscript is being submitted to a peer reviewed journal.
About Aethlon and the Hemopurifier®
Aethlon is a medical technology company focused on developing products to diagnose and treat life and organ threatening diseases. The Aethlon Hemopurifier is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression.
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. Under an Investigational Device Exemption (IDE) application, in October 2019, the FDA approved an Early Feasibility Study (EFS), which is the device equivalent of a Phase 1 clinical trial for a drug or biologic, in a single center, open label trial in 10 to 12 subjects. The study is evaluating the HEMOPURIFIER® for reducing cancer-associated exosomes prior to the administration of standard-of-care pembrolizumab (KEYTRUDA®), which is a first-line therapy for 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 a Breakthrough Device designation related to life-threatening viruses that are not addressed with approved therapies. In June 2020, the FDA approved an amendment to the Company's existing open IDE for the Hemopurifier in life threatening viral infections, to allow for the treatment of patients with SARS-CoV-2/COVID-19 infection. This will allow for up to 40 of these patients to be treated under a new Early Feasibility Study protocol at up to 20 clinical sites in the U.S.
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 patients in and successfully complete the cancer trial or the COVID-19 trial, the Company's ability to successfully treat patients under any Emergency Use pathway, the Company's ability to obtain publication of this study in a peer reviewed journal, the Company's ability to successfully complete development of its Hemopurifier, the Company's ability to raise additional funds, 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, 2020, 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.
Chief Financial Officer
Aethlon Medical, Inc.
Tony Russo, Ph.D.
Russo Partners, LLC
S.A. Noonan Communications, LLC
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SOURCE Aethlon Medical, Inc.