Aethlon Medical Announces Approval of Ebola Treatment Protocol
Aethlon Medical, Inc. announced that the United States Food and Drug Administration (FDA) has approved a clinical protocol to treat Ebola-infected individuals in the U.S. with the Aethlon Hemopurifier®. The device targets antiviral drug resistance and serves as a first-line countermeasure against Ebola and other viruses that are not addressed with proven drug therapies.
The approved Ebola treatment protocol allows for an investigational study to be conducted at up to 10 U.S. clinical sites, and up to 20 U.S. subjects may be enrolled to receive the treatment protocol. Patients who meet the enrollment criteria will receive a daily six to eight hour administration of Hemopurifier® therapy until the point that Ebola viral load drops below 1000 copies/ml. The goal of the study is to standardize and evaluate the use of the Hemopurifier® as supportive care in the treatment of Ebola virus disease.
The Ebola treatment protocol resulted from the submission of a supplement to an Investigation Device Exemption (IDE) previously approved by FDA. The supplement was entitled, "Treatment of Ebola Virus Disease (EVD) in Humans with the Aethlon Hemopurifier® Lectin Affinity Plasmapheresis Device." Based on the previously approved IDE protocol, Aethlon is conducting a clinical feasibility study of Hemopurifier® therapy in individuals infected with Hepatitis C virus (HCV) who are also receiving chronic dialysis therapy.
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