Aethlon Medical, Inc., the pioneer in developing selective therapeutic filtration devices, has announced a compassionate-use clinical programme that provides HCV-infected individuals with access to the Hemopurifier therapy, has been expanded to include individuals who experience a viral breakthrough during standard-of-care drug therapy.

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, dosing, duration and tolerability of drug therapies. A virologic breakthrough occurs when infected individuals achieve undetectable HCV levels after drug therapy initiation, but then experience a rebound in HCV levels prior to completion of therapy.  Researchers often attribute viral breakthroughs to the development of drug resistance or the emergence of HCV subtypes that are less sensitive to drug therapy.

"It is immensely disheartening when HCV-infected individuals initially respond but are then forced to discontinue their drug therapy as the result of a viral breakthrough," stated Aethlon Chairman and CEO, Jim Joyce.  "Whether it be interferon-based or future all-antiviral drug strategies, there is an enduring opportunity for our Hemopurifier to help individuals salvage benefit from their HCV drug regimen."

Aethlon previously disclosed that the compassionate-use program, which was approved by the Institutional Review Board at the Medanta Medicity Institute (Medicity), would allow individuals who previously failed or subsequently relapsed standard-of-care drug regimens with treatment access to the Aethlon Hemopurifier.  Individuals who fail drug therapy maintain detectable HCV levels throughout the course of drug therapy, whereas a treatment relapse is defined when HCV levels decrease and remain undetectable during treatment, but become detectable after cessation of therapy. The Medicity is a $360 million multi-specialty medical institute established to be a premier centre for medical tourism in India.

The Medicity is offering compassionate-use access to Hemopurifier therapy on a minimum three-day treatment regimen with the option for patients to extend treatment to a maximum period of seven consecutive days. During each treatment day, Hemopurifier therapy is administered for a duration of up to six-hours. In HCV-infected individuals who previously failed or subsequently relapsed drug therapy, the goal of Hemopurifier therapy is to accelerate the early viral kinetic response to drug therapy without adding drug toxicity or interaction risks.  More specifically, Hemopurifier therapy targets to increase immediate and rapid virologic response rates, which correlate with high clinical cure rates. In viral breakthrough patients, the goal of Hemopurifier therapy is to reset viral load to undetectable levels as a strategy to salvage the continuance and benefit of drug therapy.

Aethlon has previously reported data from a clinical programme at the Medicity that is evaluating the capability of the Aethlon Hemopurifier to accelerate HCV RNA depletion at the outset of standard of care peginterferon+ribavirin (PR) therapy.  In this study, HCV-infected individuals are enrolled to receive up to three, six-hour Hemopurifier treatments during the first three days of PR drug therapy.  Aethlon recently reported that two HCV-infected patients who received Hemopurifier therapy in combination with PR drug therapy achieved undetectable viral load at day-7, which is rarely reported in drug therapy alone.

The primary clinical endpoint of this study 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 only10.35% (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.

Aethlon expects to report updated results, including new patient data from this study in the near future.  The company also disclosed it is presently incorporating new patient data within investigational device exemption (IDE) that is expected to be submitted to FDA by year-end in an effort to gain approval to initiate HCV clinical programmes in the United States.