Aethlon Medical, Inc., the pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, announced the initiation of patient recruitment to support a clinical feasibility study of Hemopurifier therapy that is being conducted at DaVita Med Center Dialysis in Houston, Texas.

The study, which will enroll individuals infected with Hepatitis C virus (HCV) who are also receiving chronic dialysis therapy, is being conducted under an Investigational Device Exemption (IDE) approved by the United States Food and Drug Administration (FDA).


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. To date, Hemopurifier therapy has been administered outside the United States in the treatment of Ebola, HIV and HCV-infected individuals.



Under the feasibility study protocol, Aethlon will enroll ten end-stage renal disease (ESRD) patients who are infected with the Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy in an infectious disease model. Upon successful completion of the feasibility study, Aethlon plans to conduct pivotal efficacy studies required for market clearance to treat chronic viral indications.



The feasibility study will also contribute safety data to advance Hemopurifier therapy as a broad-spectrum countermeasure against category "A" bioterror and pandemic threats that are not addressed with proven drug or vaccine therapies. The virulence of such viral threats does not permit for human pivotal (efficacy) studies to be conducted. In the treatment of Ebola virus, Hemopurifier therapy is available in the US under emergency-use IDE regulatory provisions. The Company plans to pursue Humanitarian Use Device (HUD) approval pathways for Ebola and orphan indications that affect fewer than 4,000 individuals in the US each year.



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 organizations, including The U.S. 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).