July 31, 2012
/PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, reported today that the two most recent hepatitis c (HCV) infected patients to receive Hemopurifier® therapy in combination with peginterferon+ribavirin (PR) drug therapy achieved undetectable viral load at day-7, which represents a significant clinical milestone in HCV care. The Aethlon Hemopurifier® is a first-in-class medical device that selectively targets the rapid clearance of HCV from the entire circulatory system to improve benefit, dose, duration and tolerability of drug therapies.
The Aethlon study is being conducted at the Medanta Medicity Institute (Medicity), a
multi-specialty medical institute established to be a premier center for medical tourism in India. The objective of the Medicity study is to evaluate the capability of the Aethlon Hemopurifier® to accelerate HCV RNA depletion at the outset of standard of care PR therapy. Specifically, HCV-infected individuals are enrolled to receive up to three, six-hour Hemopurifier® treatments during the first three days of PR drug therapy.
"The intermittent administration of our Hemopurifier® during just the first days of interferon-based therapy is contributing to accelerate the pace and likelihood of viral load declining to undetectable levels," stated Aethlon Chairman and CEO,
. "We are now focused on expanding access to Hemopurifier® therapy and increasing dosing schedules to further optimize treatment outcomes."
The primary clinical endpoint of the Medicity protocol has been to increase the incidence of rapid virologic response (RVR), defined as undetectable HCV RNA at day 30 of therapy. RVR represents the clinical endpoint that best predicts treatment cure, otherwise known as sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after the completion of PR drug therapy. As a point of reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that only 10.35% (n=318/3070) of PR treated patients achieved a RVR. However, patients that achieved a RVR had SVR rates of 86.2% (n=274/318) versus SVR rates of 32.5% (n=897/2752) in non-RVR patients. While the incidence of undetectable HCV RNA at day-7 is not reported in the IDEAL study, the study did reveal that just 4.3% (n=131/3070) of patients achieved undetectable HCV RNA at day-14, which equated to a 91% (n=118/131) SVR rate.