Aethlon Medical has entered into a definitive agreement with DaVita Clinical Research (DCR) to provide clinical management services to support the forthcoming feasibility study of the Aethlon Hemopurifier.
The Hemopurifier is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumor-secreted exosomes that suppress the immune system of cancer patients. Aethlon further announced that the principal investigator for this study will be Dr Stephen Z. Fadem.
The clinical trial site location will be DaVita MedCenter Dialysis in Houston. Dr Fadem is co-medical director of DaVita MedCenter Dialysis and this center is one of the three largest dialysis centers in the country with 72 treatment stations.
Aethlon previously disclosed that the US Food and Drug Administration (FDA) had approved an Investigational Device Exemption (IDE) that allows the company to initiate human feasibility studies of the Aethlon Hemopurifier in the US.
Under the feasibility study protocol, Aethlon is to treat ten ESRD patients infected with Hepatitis C virus (HCV) to demonstrate the safety of Hemopurifier therapy. Successful completion of the feasibility study will set the stage for Aethlon to conduct pivotal studies required for market clearance to treat HCV and potentially other disease indications.
Aethlon Medical CEO Jim Joyce said that the combination of DCR, DaVita MedCenter Dialysis, and Dr Fadem provides Aethlon with the ideal team of professionals and infrastructure with which to conduct its infectious disease clinical study.
"Additionally, their proximity to M.D. Anderson Cancer Center and other specialty facilities located within the Texas Medical Center provide for a unique location to conduct future clinical investigations of Hemopurifier® therapy in a variety of life-threatening health conditions," Joyce added.