By M. Marin
Expanding the Potential Indications for Hemopurifier Treatment
Aethlon Medical’s (NASDAQ:AEMD) clinical trials are moving forward and expanding, as AEMD continues to demonstrate the effectiveness of its lead product, the Aethlon Hemopurifier®, in a broad range of viruses and conditions in single patient emergency use cases and in in vitro analysis, including COVID-19 and various variants and Monkeypox, among others. The Aethlon Hemopurifier® is being studied in a severe COVID-19 clinical trial under the company’s open IDE (Investigational Device Exemption) for life-threatening viral infections.
The safety and feasibility of the Hemopurifier is being evaluated in an Early Feasibility Study (EFS) that will enroll up to 40 COVID-19 ICU patients. The first patient was enrolled in this study in June 2022 and has completed the Hemopurifier treatment. AEMD has nine fully activated hospitals that are actively screening patients for the trial.
In addition to this study, the Hemopurifier has demonstrated positive results in two severely ill patients under individual emergency use and in in vitro analysis. The Hemopurifier has produced positive results in binding seven variants of the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) virus in vitro, as discussed in an article1 that AEMD’s CEO Dr. Charles J. Fisher Jr. and the company’s Chief Medical Officer Dr. Steven LaRosa contributed to.
The company is also conducting a study of the impact of the Hemopurifier on patients with head and neck cancer. The company is looking to expand this trial to one or more additional sites to accelerate patient recruitment. AEMD is also working to launch a broader oncology trial to study the impact of the Hemopurifier on a variety of cancerous tumors. Depending on trial results, it could have broad commercial and economic implications for AEMD, in our view.
Device Has Been Effective Treating Monkeypox, With Cases on the Rise
Recently, Monkeypox cases have been on the rise. The WHO (World Health Organization) is monitoring MPV closely, given that cases have been reported in multiple countries and case numbers are increasing. In Nigeria, there has been an ongoing outbreak since 2017, according to the Harvard School of Public Health. In 2Q22, one death was reported in Nigeria. The International Health Regulations Emergency Committee met regarding the multi-country monkeypox outbreak on June 23, 2022. Cases have been reported in about 50 countries, with the majority (over 85%) reported in Europe and about 11% in North America. Moreover, AEMD believes that actual case numbers might be under-reported, as the disease and symptoms are not well-known by diagnosing physicians at this point.
Importantly, the Hemopurifier has demonstrated effectiveness against monkeypox. In 2008, AEMD commissioned Battelle Memorial Institute to run a monkeypox virus (MPV) in vitro study. Results of that study demonstrated that high concentrations of MPV (approximately 35 thousand cpu/ml) were rapidly depleted from cell culture fluids that were circulated through the Hemopurifier. Within 20 hours, the Hemopurifier had removed nearly all (98%) of infectious MPV.
Specifically, the data indicated that the Hemopurifier removed 44% of infectious MPV in the first hour of testing, 82% after six hours, and 98% after 20 hours. The studies were conducted in triplicate and data verification was provided by real-time polymerase chain reaction.
Monkeypox study: Hemopurifier infectious MPV removal
▪ 44% in the first hour of testing
▪ 82% after six hours
▪ 98% after 20 hours
These in vitro and human treatment results demonstrate the potential versatility of the Hemopurifier in treating a range of infections and tumors. We believe they support the company’s expanding development and clinical trial efforts around the device.
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1. Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus nivalis Agglutinin, published in bioRxiv