Provided by Healio
June 25, 2013
The FDA has approved an investigational device exemption for a human feasibility study of a medical device for treating patients with hepatitis C, according to a press release.
The Aethlon Hemopurifier (Aethlon Medical) is intended for use in combination with interferon-based therapy or antiviral treatments, to improve early viral kinetic response without introducing additional drug toxicity. The device includes a plasma membrane containing immobilized affinity lectin Galanthus nivalis agglutinin, and allows extracorporeal therapeutic delivery through instruments currently available in medical facilities. According to the release, the Hemopurifier would benefit patients who experience viral rebound and require treatment discontinuation, as well as in those for whom standard or antiviral therapy is contraindicated.
Planned testing for the device will include the enrollment of 10 patients with end-stage renal disease (ESRD) and HCV infection. Participants will have received no pharmaceutical HCV therapy within the previous 30 days or longer. After a control phase of three dialysis treatments over 1 week, patients will subsequently receive Hemopurifier therapy during six dialysis sessions across 2 weeks. Incidence of adverse events will be compared between the control and Hemopurifier phases, and change to viral load during treatment will be assessed.
Prior studies outside of the United States indicated that Hemopurifier use was well tolerated among treatment-naive, HIV/HCV coinfected patients with ESRD when added to standard dialysis, decreasing viral loads from both diseases by an average of more than 50% per treatment. Additional studies of patients with HCV and without ESRD, in which three Hemopurifier treatments were administered in combination with interferon-based therapy, led to undetectable HCV viral loads within as few as 7 days among participants with HCV genotype 1.
“Aethlon Medical has been laying the groundwork necessary to implement the now approved clinical trial protocol for several years,” Rod Kenley, company president, said in the release. “While there is still some work to be done, today the biggest hurdle has been cleared, and we are anxious to make rapid progress toward commercialization.”