Aethlon Medical, Inc. last week announced they have received U.S. Food and Drug Administration (FDA) approval for a clinical protocol to treat Ebola-infected individuals in the U.S. with the Aethlon Hemopurifier.
In the treatment of viral pathogens, the Hemopurifier is a first-in-class bio-filtration device designed for the single-use removal of viruses and shed glycoproteins from the circulatory system of infected individuals. 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.
As the approved Ebola treatment protocol is a deviation from the HCV protocol, Aethlon was required to clearly distinguish data collected in the supplemental Ebola protocol study from data derived from the Company’s HCV trials.
Capture of Ebola Viruses
Aethlon previously reported that Hemopurifier therapy was successfully administered to a critically-ill Ebola patient 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 been 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 unconscious and suffering from multiple organ failure, which required mechanical ventilation, continuous dialysis and the administration of vasopressor medications. The patient has since made a full recovery and returned home to his family.
Hemopurifier is a registered, protected term of Aethlon Medical.
