Aethlon Medical monitors Ebola outbreak, cites device preparedness
Aethlon Medical Inc. (NASDAQ: AEMD) announced it is monitoring the current Bundibugyo Ebola virus outbreak in Democratic Republic of the Congo and Uganda and remains prepared to engage with healthcare authorities regarding potential use of its Hemopurifier technology.
The World Health Organization and public health agencies have identified the outbreak as involving the Bundibugyo strain of Ebola virus. Health authorities have expressed concern about cross-border transmission and potential regional spread, according to the company's statement based on public health reports.
The Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from blood circulation. During the 2014 Ebola outbreak, the device was administered to a critically ill Ugandan physician at Frankfurt University Hospital under emergency-use circumstances.
The physician was unconscious and experiencing multiple organ failure when treatment began. Following a single 6.5-hour Hemopurifier treatment, the patient's viral load reportedly declined from approximately 400,000 Ebola virus copies per milliliter to approximately 1,000 copies per milliliter. The virus became undetectable five days after treatment, and the patient recovered.
In January 2015, the U.S. Food and Drug Administration approved an Investigational Device Exemption supplement establishing a regulatory pathway for potential investigational use of Hemopurifier therapy in Ebola-infected individuals in the United States.
The Hemopurifier holds FDA Breakthrough Device designation for treating individuals with advanced or metastatic cancer unresponsive to standard therapy and for treating life-threatening viruses not addressed with approved therapies.
"We believe the current Ebola outbreak reinforces the ongoing need for broad-spectrum therapeutic approaches capable of addressing viral threats where approved drug therapies or vaccines may be limited," said James B. Frakes, chief executive officer.
