Aethlon Medical provides update on availability of Hemopurifier device

Aethlon Medical (AEMD) provided a statement of its investigational medical device with respect to H5N1 avian influenza “Bird Flu.” The company stated, “Aethlon has recently received a number of inquiries regarding the potential utility of its Hemopurifier device in the treatment of Bird Flu. These inquiries come on the heels of the reporting of isolation of Bird Flu in dairy cows, 60 human cases in eight states including a case of severe infection in Louisiana, and yesterday’s declaration of a state of emergency in California. The Aethlon Hemopurifier is an investigational extracorporeal medical device designed to remove enveloped viruses and extracellular vesicles from the bloodstream. The device incorporates plasma separation, size exclusion, and affinity binding to a proprietary resin containing the plant lectin Galanthus nivalis agglutinin bound to a medical grade diatomaceous earth. Enveloped viruses and extracellular vesicles contain the sugar mannose on their surface, which is the therapeutic target of the GNA. Aethlon has previously contracted Battelle labs to examine the in vitro removal of influenza viruses including H5N1 by a scaled down version of the Aethlon Hemopurifier. In this experiment, cell culture media was spiked with the H5N1 virus and continuously circulated over the device. Samples were taken periodically to examine viral removal by the device. In this study, a miniature version of the device removed 99% of H5N1 following 6 hours of treatment. While the Aethlon Hemopurifier has not yet been used to treat patients with severe influenza, including those infected with H5N1, it has been used in 38 patients across 164 distinct treatment sessions, targeting diseases such as hepatitis C, HIV, and in patients critically ill due to COVID-19 and Ebola. The Hemopurifier has a “breakthrough device” designation with the FDA for life-threatening viruses for which there is no effective treatment. Current treatment guidelines from the Center for Disease Control and Prevention (https://www.cdc.gov/bird-flu/hcp/novel-av-treatment-guidance/), for hospitalized patients with suspected Bird Flu (H5N1), are to initiate antiviral therapy as soon as possible with Oseltamivir, with or without combination therapy with Baloxavir. Clinical failures during Oseltamavir therapy due to the development of antiviral resistance have been observed in hospitalized patients with H5N1. This phenomenon raises the possibility that novel treatment strategies may be required. Aethlon Medical will monitor this situation closely and interact with hospitals, the state of California, and the FDA as appropriate if cases mount and currently available treatments are not effective.”