Aethlon Medical's Hemopurifier Shows Potential in Capturing H5N1 Bird Flu In Vitro

Key Insights

• Aethlon Medical reports that its Hemopurifier device demonstrated 99% removal of H5N1 influenza virus in in vitro testing after 6 hours.
• The Hemopurifier, an investigational extracorporeal device, targets enveloped viruses via the mannose on their surface using GNA lectin.
• The device has Breakthrough Device designation from the FDA for life-threatening viruses without effective treatments.

Aethlon Medical, Inc. (Nasdaq: AEMD) has provided an update on the potential utility of its Hemopurifier device in treating H5N1 avian influenza, commonly known as Bird Flu, amid recent reports of its isolation in dairy cows and human cases across several states.

The Hemopurifier is an investigational extracorporeal medical device engineered to eliminate enveloped viruses and extracellular vesicles from the bloodstream. It employs plasma separation, size exclusion, and affinity binding, utilizing a proprietary resin with Galanthus nivalis agglutinin (GNA), a plant lectin that targets the mannose on the surface of enveloped viruses and extracellular vesicles.

In Vitro Efficacy Against H5N1

In vitro studies conducted by Battelle labs demonstrated that a scaled-down version of the Aethlon Hemopurifier removed 99% of the H5N1 virus from cell culture media within 6 hours. The experiment involved continuous circulation of H5N1-spiked media over the device, with periodic sampling to assess viral removal.

Clinical Experience and Regulatory Status

While the Hemopurifier has not been used to treat H5N1-infected patients, it has been utilized in 38 patients across 164 treatment sessions for conditions such as hepatitis C, HIV, COVID-19, and Ebola. The device holds a Breakthrough Device designation from the FDA for life-threatening viruses lacking effective treatments.

Current Treatment Landscape and Aethlon's Response

Current CDC guidelines recommend Oseltamivir, potentially with Baloxavir, for hospitalized patients with suspected H5N1. However, instances of antiviral resistance to Oseltamivir have been observed, highlighting the need for novel treatment approaches. Aethlon Medical is closely monitoring the situation and is prepared to collaborate with hospitals, the state of California, and the FDA if cases escalate and existing treatments are inadequate.

The Hemopurifier also holds an FDA Breakthrough Device designation for advanced or metastatic cancer, targeting cancer types where extracellular vesicles contribute to disease development or severity.