Two 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, representing 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.
Approximately 4 million Americans and 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is the leading cause of liver transplant in the U.S. Aethlon Medical is a pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions.
The Aethlon study is being conducted at the Medanta Medicity Institute (Medicity), a $360 million 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, Jim Joyce. “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.
In the Medicity study, Aethlon reported that Hemopurifier® therapy has been well tolerated and without device-related adverse events in ten treated patients. Of these ten patients, seven patients were infected with HCV genotype-1; two patients were infected with HCV genotype-3; and one patient was infected with HCV genotype-5. At present, undetectable HCV RNA is reported in eight of the 10 treated patients. Of the two patients with detectable HCV RNA, one discontinued PR therapy as a result of a diabetes related condition.
HCV RNA is undetectable in all patients (n=4) that have been monitored for 48 weeks since receiving Hemopurifier® therapy. Among the 10 treated patients, Aethlon reported that six genotype-1 patients received the three treatment Hemopurifier® protocol, which resulted in four (67%) patients achieving a RVR. The IDEAL study predicts it would normally require approximately 40 PR treated patients to achieve 4 RVR outcomes. Both patients who achieved undetectable HCV RNA at day-7 also achieved a RVR. Beyond the high likelihood of a SVR, genotype-1 patients that achieve a RVR also have the opportunity to reduce the duration of PR drug therapy from 48 weeks to 24 weeks.
As a result of Hemopurifier® + PR therapy outcomes, Aethlon is seeking to establish clinical sites that will provide non-Indian citizens with access to Hemopurifier® therapy. A response from the Medicity internal review board (IRB) related to Aethlon’s request to expand clinical programs at the Medicity is currently pending. Aethlon also disclosed that it is preparing to resubmit an investigational device exemption (IDE) to the FDA, which will incorporate the Medicity data, in an effort to gain approval to initiate HCV clinical programs in the United States
Approximately 100 Hemopurifier® treatments have been administered in human studies. Previously, studies of the Hemopurifier® have been conducted at the Apollo, Fortis, and Sigma New Life hospitals in India. These studies demonstrated that Hemopurifier® therapy could safely reduce viral load in both HIV and HCV-infected dialysis patients without the administration of antiviral drug therapies. The Medicity study represents the first Hemopurifier® study in non-dialysis patients. In vitro studies have further validated the ability of the Hemopurifier® to capture a broad-spectrum of viral pathogens classified as bioterror or pandemic threats.