The US Food and Drug Administration (FDA) has granted approval for Aethlon Medical‘s clinical protocol to treat Ebola-infected individuals with its Hemopurifier in the US.
The Aethlon Hemopurifier is a bio-filtration device designed for the single-use removal of viruses and shed glycoproteins from the circulatory system of infected individuals.
Hemopurifier targets antiviral drug resistance and is a first-line countermeasure against Ebola and other viruses, which are not tackled with proven drug therapies.
An approved protocol allows the company to carry out an investigational study in ten US clinical sites, which will include 20 US subjects who will receive the treatment protocol.
Aethlon Medical said patients who meet the enrolment criteria will receive a daily six to eight hour administration of Hemopurifier therapy until the Ebola viral load drops below 1,000 copies/ml.
The trial is designed to standardise and assess the use of Hemopurifier as supportive care in the treatment of the Ebola virus disease.
The protocol resulted from the submission of a supplement entitled ‘Treatment of Ebola Virus Disease (EVD) in Humans with the Aethlon Hemopurifier Lectin Affinity Plasmapheresis Device’ to an investigation device exemption (IDE) previously approved by the FDA.
Currently, the company is conducting a clinical feasibility trial of Hemopurifier therapy in individuals infected with the hepatitis C virus (HCV) who are also receiving chronic dialysis therapy, based on previously approved IDE protocol.
As the approved Ebola treatment protocol is a deviation from the HCV protocol, the company is required to clearly differentiate data collected in the supplemental Ebola protocol trial from data derived from its HCV trials.
Image: Aethlon Hemopurifier. Photo: courtesy of Aethlon Medical, Inc.