Therapeutic devices developer Aethlon Medical has obtained approval from the US Food and Drug Administration (FDA) for a clinical protocol to treat Ebola-infected individuals with Aethlon Hemopurifier in the US.
The Hemopurifier is a bio-filtration device that has been developed for the single-use removal of viruses and shed glycoproteins from the circulatory system of infected individuals.
According to the company, the device targets antiviral drug resistance and serves as a first-line countermeasure against Ebola and other viruses, which are not addressed with proven drug therapies.
The approved protocol allows to conduct an investigational study in around ten US clinical sites, and up to 20 US subjects may be enrolled to receive the treatment protocol.
The study is being conducted to standardize and evaluate the use of Hemopurifier as supportive care in the treatment of Ebola virus disease.
Aethlon noted that the Ebola treatment protocol resulted from the submission of a supplement to an Investigation Device Exemption (IDE) previously approved by FDA.
It was entitled "Treatment of Ebola Virus Disease (EVD) in Humans with the Aethlon Hemopurifier Lectin Affinity Plasmapheresis Device."
The company is conducting a clinical feasibility trial of Hemopurifier therapy in individuals infected with Hepatitis C virus (HCV) who are also receiving chronic dialysis therapy, based on the previously approved IDE protocol.
Image: Aethlon Hemopurifier. Photo: courtesy of Aethlon Medical, Inc.