Aethlon Medical, Inc. has finished the successful dosing of the first chronic dialysis patient diagnosed with hepatitis C virus (HCV) in a clinical trial to evaluate its investigational Hemopurifier treatment protocol without any relevant adverse events. The study is being conducted at the DaVita Med Center Dialysis in Houston and includes nine other patients.
The Hemopurifier system is a bio-filtration device expected to eliminate a wide spectrum of infectious viruses from the circulatory system, and is one of the Compnay’s pipeline targeted therapeutic systems being developed to treat not only infectious diseases, but also cancer. The study includes 10 patients to be treated with six courses of Hemopurifier therapy, and the first patient has been successfully treated, according to a press release from the company.
The feasibility examinations are meant to evaluate the safety of the Hemopurifier in order to accelerate its development process as a viable therapy for the treatment not only of chronic conditions, including HCV and HIV, but also acute bioterror and pandemic threats with lack of drug treatment or vaccination. The ongoing study of the Hemopurifier protocol has been approved by the U.S. Food and Drug Administration (FDA). The company is now planning on filling new submissions.
“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 U.S. each year,” explained the chairman and CEO of Aethlon Medical, Jim Joyce.
The Hemopurifier protocol is already used in other countries outside the U.S. to treat patients infected with HCV, Ebola and HIV. Previous in vitro studies conducted on bioterror and pandemic threats already demonstrated the ability of the device to capture the 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.
In other news on hepatitis, Aethlon Medical released final clinical outcomes, including rapid virologic response (RVR) and sustained virologic response (SVR) rates, in patients infected with HCV who were treated with the Hemopurifier protocol. The study was conducted at the Medanta Medicity Institute in Gurgaon, India, and was the last step before the launch of the first human clinical study in the United States.