Aethlon Medical, the pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, announced that the first patient enrolled in the company's FDA approved feasibility study has completed their full Hemopurifier treatment protocol without any device-related adverse events. The study protocol, which is being administered at DaVita Med Center Dialysis in Houston, is enrolling ten chronic dialysis patients infected with hepatitis C virus (HCV) to receive a six treatment protocol of Hemopurifier therapy. The Aethlon Hemopurifier is a first-in-class bio-filtration device that provides the broad-spectrum elimination of infectious viruses from the circulatory system of infected individuals.
The feasibility study will contribute safety data to advance the Hemopurifier as a candidate therapy to address chronic conditions such as HIV and HCV, as well as acute bioterror and pandemic threats that are not addressed with proven drug or vaccine therapies.
"With our feasibility study now under way, we will initiate our previously communicated plan to file Humanitarian Use Device (HUD) submissions that provide a potential FDA market clearance pathway to treat viral indications that affect fewer than 4,000 individuals in the US each year," stated Jim Joyce, chairman and chief executive officer, of Aethlon Medical.
To date, Hemopurifier therapy has been administered outside the United States in the treatment of Ebola, HIV and HCV-infected individuals. Previously, in vitro studies of bioterror and pandemic threats have verified Hemopurifier capture of Ebola hemorrhagic virus, dengue hemorrhagic virus, lassa hemorrhagic virus, H5N1 avian influenza (bird flu), the reconstructed 1918 influenza virus (r1918), 2009 H1N1 influenza virus (swine flu), West Nile virus, and monkeypox, which serves as a model for human smallpox infection. These studies were conducted with leading government and non-government research organisations, including The US Army Medical Research Institute of Infectious Diseases (USAMRIID), The Centers for Disease Control and Prevention (CDC), The National Institute of Virology (NIV), The Battelle Biomedical Research Center (BBRC) and The Southwest Foundation for Biomedical Research (SFBR).