US-based therapeutic devices developer Aethlon Medical has started enrolling patients to support a clinical feasibility trial of Hemopurifier therapy to treat hepatitis C virus (HCV).
Under the feasibility study protocol, the company will enrol ten end-stage renal disease (ESRD) patients who are infected with HCV to show the safety of Hemopurifier therapy in an infectious disease model.
Following successful completion of the feasibility trial, Aethlon Medical intends to conduct pivotal efficacy trials required for market clearance to treat chronic viral indications.
The trial is being conducted at DaVita Med Center Dialysis under an investigational device exemption (IDE) approved by US Food and Drug Administration (FDA).
The first-class bio-filtration device Hemopurifier eliminates viruses and immunosuppressive proteins from the circulatory system of infected individuals.
Hemopurifier therapy was administered outside the US to treat Ebola, HIV and HCV infected individuals.
According to the company, the feasibility trial 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.
In the US, Hemopurifier therapy is available for the the treatment of Ebola virus under emergency-use IDE regulatory provisions.
Aethlon Medical plans to pursue Humanitarian Use Device (HUD) approval pathways for Ebola and orphan indications that affect fewer than 4,000 individuals in the US every year.
In vitro trials of bioterror and pandemic threats previously 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.
In November, the Hemopurifier device was named as one of the 25 best inventions of 2014 by Time Magazine.
Image: Aethlon Hemopurifier. Photo: courtesy of Aethlon Medical Inc.