Aethlon MedicalDiscloses Ebola Treatment Pathways in the United States
Aethlon Medical, Inc. disclosed that it will provide Hemopurifier® therapy under FDA compassionate use access provisions to support potential requests by qualified physicians and institutes that may seek to treat Ebola virus infection in the United States.
The Aethlon Hemopurifier® is a first-in-class bio-filtration device that targets the rapid elimination of viruses and immunosuppressive proteins from the circulatory system of infected individuals. At present, no antiviral therapy or vaccine has proven to be effective against Ebola virus infection in humans. According to the World Health Organization (WHO), nearly 5,000 deaths have been attributed to the current ebola virus epidemic.
Based on guidance from FDA, the treatment of ebola virus infection provides for a unique circumstance where a physician or health care provider may wish to pursue the compassionate use of Hemopurifier® therapy based on the serious nature of the disease and absence of alternative therapies. Compassionate use provisions are typically approved by FDA on an individual patient basis, but may be expanded to include a small group.
Aethlon also disclosed that it plans to submit its first ebola treatment data to the FDA as a means to support the goal of further expanding treatment access through emergency use regulatory pathways.
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