SAN DIEGO, PRNewswire/ — Aethlon Medical, Inc. (AEMD), the pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, today 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®. 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. A detailed description of the HCV study, including treatment protocol and patient inclusion/exclusion criteria can be accessed online at www.clinicaltrials.gov.
As the approved Ebola treatment protocol is a deviation from the HCV protocol, Aethlon is required to clearly distinguish data collected in the supplemental Ebola protocol study from data derived from the Company’s HCV trials. The Company may not combine data from the two studies. Aethlon must also comply with specified patient protection procedures established by the applicable institution including its institutional review board approval prior to treating a patient under the supplement protocol. The Company must also report any unanticipated adverse events resulting from the supplement protocol to the FDA within 10 working days of the use of the device. There is no assurance that any Ebola-infected patients will be treated under the protocol. (read more)