Aethlon Medical, Inc., the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, has submitted an Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA) that requests permission to initiate a clinical feasibility study of Hepatitis-C (HCV) infected individuals enrolled to receive Hemopurifier therapy.
Upon approval by FDA, an IDE allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application.
The Aethlon Hemopurifier is a first-in-class medical device that targets the rapid clearance of HCV from the entire circulatory system. The goal of therapy is to improve the benefit of interferon-based or all-antiviral HCV drug regimens. Aethlon's IDE submission included clinical data from Hemopurifier studies of HCV-infected individuals conducted at the Apollo Hospital, Fortis Hospital, and the Medanta Medicity Institute, all located in India.
As requested by FDA during a Pre-IDE meeting, Aethlon also provided data that quantified the capture of HCV within the Hemopurifier during treatment. The proposed feasibility study would enroll 10 patients with End Stage Renal Disease (ESRD) and concomitant HCV infection.
The study would be conducted by the Renal Research Institute (RRI), which was established in 1997 as a partnership between Fresenius Medical Care (FMC) and Beth Israel Medical Center, New York City.
The Aethlon Hemopurifier is a first-in-class medical device that selectively targets the rapid clearance of infectious viral pathogens and immunosuppressive proteins from the entire circulatory system. In the treatment of Hepatitis C virus (HCV), human studies have demonstrated that Hemopurifier therapy may improve immediate, rapid and sustained virologic response rates when administered in the first few days of standard-of-care drug therapy. In addition to accelerating viral load depletion, post-treatment analysis of the Hemopurifier has documented the capture of up to 300 billion HCV copies of HCV during a single six-hour treatment. Access to Hemopurifier therapy is available on a compassionate-use basis through the Medanta Medicity Institute (Medicity), a leading center for medical tourism in India. The Medicity is offering treatment access to infected individuals who previously failed or subsequently relapsed standard-of-care drug regimens. The Hemopurifier is also being offered as a salvage therapy to infected individuals who suffer a viral breakthrough during standard-of-care therapy. U.S. studies of the Hemopurifier are currently pending approval of an IDE submitted to FDA.