SAN DIEGO, Dec. 12, 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, announced today that a compassionate-use clinical program 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 center for medical tourism in India. Additional details about the Medicity can be found online at www.medanta.org. Under the compassionate-use program, the Medicity is offering Hemopurifier® therapy to HCV-infected individuals that reside in India or travel from other regions and meet the inclusion/exclusion criteria that have been established for participation. The Treatment Protocol 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.