Aethlon Medical, Inc. has announced that the Medical Devices Bureau of Health Canada has approved a clinical study protocol to treat Ebola-infected individuals with the Aethlon Hemopurifier.
The Hemopurifier is a first-in-class affinity biofiltration device designed for the broad-spectrum elimination of viral pathogens from the circulatory system of infected individuals. The device targets antiviral drug resistance and serves as a first-line countermeasure against Ebola and other life-threatening viruses that are not addressed with proven drug therapies.
The Health Canada approved protocol is entitled, “The Treatment of Ebola Virus Disease (EVD) in Humans with the Aethlon Hemopurifier Lectin Affinity Plasmapheresis Device”. The protocol allows for an investigational study of Hemopurifier therapy to be conducted in up to 3 human subjects.
The objective of the study is to standardize and evaluate the use of the Hemopurifier as supportive care in the treatment of EVD. Aethlon further disclosed that the Ebola study protocol had also been approved by the University Health Network (UHN) Research Ethics Board, based in Toronto, Ontario.
Previously, Aethlon disclosed that the U.S. Food and Drug Administration (FDA) approved a clinical protocol to treat Ebola-infected individuals with Hemopurifier therapy in the U.S. The company has also submitted a Humanitarian Use Device (HUD) application with FDA to support potential market clearance of the Hemopurifier as a treatment for EVD.
The first administration of Hemopurifier therapy to an ebola-infected individual occurred at Frankfurt University Hospital in Germany. On November 14, 2014, the resulting Hemopurifier treatment data was presented at the American Society of Nephrology (ASN) Annual Meeting by Helmut Geiger, M.D., Chief of Nephrology at Goethe University, Frankfurt University Hospital.
Dr. Geiger reported that 242 million Ebola viruses were captured within the Hemopurifier during treatment, a number verified by a post-treatment elution protocol. The elution protocol has since be repeated, which resulted in second measurement of 253 million copies of Ebola virus captured within the Hemopurifier.
Dr. Geiger also reported that the patient’s viral load prior to the administration of a single 6.5-hour Hemopurifier treatment was measured at 400,000 virus copies per milliliter of blood (copies/ml). A post-treatment viral load measurement was reported to be 1,000 copies/ml. The treatment was well tolerated with no adverse events reported.
At the time of treatment, the Ebola patient was comatose and suffering from multiple organ failure, which required mechanical ventilation, continuous dialysis and the administration of vasopressor medications. The patient made a full recovery and returned home to his family.