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Dec. 3, 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, today announced the initiation of a compassionate-use clinical program to treat individuals infected with Hepatitis C virus (HCV). The compassionate-use program, which has been approved by the Institutional Review Board at the Medanta Medicity Institute (Medicity), will provide individuals who previously failed or subsequently relapsed standard-of-care drug regimens with treatment access to the Aethlon Hemopurifier®. The 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.
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
It is estimated that approximately 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is a leading cause of liver transplantation. The opportunity to address infected individuals who fail or subsequently relapse drug therapy is significant as retreatment prognosis with drug therapy alone is often poor. 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.
"We are grateful to the Medicity for providing us the opportunity to improve Hepatitis C treatment outcomes," stated Aethlon Chairman and CEO,
Jim Joyce. "While we plan to be cautious in our initial ramp-up, we do look forward to augmenting our established contract revenue stream with Hemopurifier® product sales."
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 up to six-hours. In HCV, the goal of therapy is to accelerate the early viral kinetic response to standard-of-care 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.