US-based therapeutic devices developer Aethlon Medical has announced the first patient enrolled in its clinical feasibility trial has completed the full Hemopurifier treatment protocol, without any device-related adverse events.
The trial is being conducted at DaVita Med Center Dialysis under an investigational device exemption (IDE) approved by US Food and Drug Administration (FDA).
In the trial, ten chronic dialysis patients infected with hepatitis C virus (HCV) will receive a six treatment protocol of Hemopurifier therapy.
As a bio-filtration device, Hemopurifier eliminates viruses and immunosuppressive proteins from the circulatory system of infected individuals.
Safety data from the feasibility trial will help in advancing 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.
Aethlon Medical chairman Jim Joyce said: "With our feasibility study now underway, 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."
Hemopurifier therapy was administered outside the US to treat Ebola, HIV and HCV infected individuals.
In-vitro trials of bioterror and pandemic threats showed 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 trials were conducted with the US Army Medical Research Institute of Infectious Diseases (USAMRIID), Centers for Disease Control and Prevention (CDC), National Institute of Virology (NIV), the Battelle Biomedical Research Center (BBRC) and the Southwest Foundation for Biomedical Research (SFBR).
Image: Aethlon Hemopurifier. Photo: courtesy of Aethlon Medical Inc.