SAN DIEGO: Aethlon Medical, Inc. has disclosed that it will provide Hemopurifier® therapy under FDA expanded access "emergency use" provisions to support requests from qualified physicians and institutes that may seek to treat ebola virus infection in the United States.
Aethlon previously disclosed that it would provide Hemopurifier® therapy on a humanitarian basis through FDA compassionate use access provisions, which allow for the use of an investigational device to treat an individual patient or small group based on clearance by FDA prior to treatment.
Based on FDA guidance, Aethlon will now provide Hemopurifier® therapy to treat Ebola infection through expanded access "emergency use" provisions in the United States. Expanded access "emergency use" of an investigational device does not require advance FDA approval for life threatening circumstances for which an alternative therapy is not available. At present, no antiviral therapy or vaccine has proven to be effective against Ebola virus infection in humans.
The Aethlon Hemopurifier® is a first-in-class bio-filtration device that targets the rapid elimination of viruses and immunosuppressive proteins from the circulatory system of infected individuals. In the treatment of Ebola, Aethlon recently announced that Hemopurifier® therapy was administered to Ugandan physician, who was infected with Ebola in Sierra Leone where he was treating Ebola patients. At the time of treatment, which occurred at Frankfurt University Hospital in Germany, the patient was unconscious and suffering from multiple organ failure.
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). Post-treatment viral load was measured at 1,000 copies/ml and never again rose above that level. The treatment was well tolerated with no adverse events reported. Additionally, a post-treatment elution protocol verified that 242 million Ebola viruses were captured within the Hemopurifier® during treatment. Since the administration of Hemopurifier® therapy, Frankfurt University Hospital officials have reported that the Ebola virus is no longer detectable in the patient's blood and full recovery is expected.
Aethlon will soon begin the first U.S. clinical Hemopurifier® studies following the United States Food and Drug Administration's (FDA)'s approval of an Investigational Device Exemption (IDE). The study will contribute safety data to advance the device as a broad-spectrum countermeasure against pandemic threats, including Ebola and chronic viral pathogens such as HIV and Hepatitis C (HCV).