SAN DIEGO--(BUSINESS WIRE)--Feb. 18, 2009--
Aethlon Medical, Inc. (OTCBB:AEMD) announced today that it has completed
a 30-day treatment case study to further evaluate the safety and
efficacy of the Aethlon Hemopurifier® as a candidate treatment for
Hepatitis-C Virus (HCV) infection. The Hemopurifier® is a first-in-class
medical device that assists the immune response in combating infectious
disease through real-time therapeutic filtration of infectious viruses
and immunosuppressive proteins. As in previous studies, which
demonstrated robust viral load reductions resulting from three
Hemopurifier® treatments administered in a one-week trial, the study
enrolled an HCV patient suffering from end-stage renal disease (ESRD)
requiring regular kidney dialysis treatment. The study goal was to
further demonstrate the Aethlon Hemopurifier® inhibits the progression
of HCV in infected ESRD patients. The study protocol provided for 12
Hemopurifier(R) treatments to be administered during the patient’s
normally scheduled dialysis treatment. As a result, a 4-hour
Hemopurifier® treatment was administered thrice weekly over a period of
30 days. There were no observed adverse events were reported in any of
the treatments. The study was conducted at the Fortis Hospital in Delhi,
India. Aethlon will disclose viral load and associated data upon receipt
from testing laboratories. The insight obtained from the study will help
define future clinical protocols and early commercialization strategies.
The study data may also be utilized to expand the scope of an IDE
submission to the FDA to include the potential use of the Hemopurifier®
in the United States as a device designed for the single-use removal of
HCV from blood. At present, the focus of Aethlon’s IDE submission has
been directed towards high risk bioterror and emerging pandemic threats.
It is estimated that up to 20% of the 1.6 million global ESRD population
is infected with HCV. Beyond the treatment of infected ESRD patients,
the overall opportunity for the Hemopurifier® is HCV care is
significant, as approximately 180 million people worldwide (3% of the
world's population) are HCV infected. According to the World Health
Organization (WHO), only 30-50% of infected patients will beneficially
respond to the 48-week pegylated interferon-ribavirin treatment standard.
“While we still have much work ahead, I am proud that our research and
clinical programs allow us the opportunity to expand the therapeutic
filtration industry beyond kidney dialysis and into the much larger
infectious disease and cancer markets,” stated Aethlon Chairman and CEO,
Jim Joyce. “The continued demonstration of Hemopurifier® safety and
effectiveness increases the likelihood that our technology will be
available to extend and improve the lives of those suffering from these
horrific conditions,” concluded Joyce.
In a previous studies conducted the Fortis Hospital, six ESRD patients
received a series of three, 4-hour Hemopurifier® treatments every other
day during the course of one week. The treatment regimen also mirrored
the patient's normal kidney dialysis schedule, allowing for the
inclusion of the Hemopurifier® without disrupting dialysis treatment.
Robust viral load reductions were observed in three HCV patients who
completed the three-treatment protocol. Patient #1 had a 95% reduction
three days post treatment and 89% reduction seven days post treatment.
Patient #2 had a 85% reduction three days post treatment and 50%
reduction seven days post treatment, and patient #3 had a 60% reduction
three days post treatment and 83% reduction seven days post treatment.
Aethlon additionally disclosed that it soon expects the receipt of viral
load and blood chemistry data resulting from a recently completed 30-day
HIV treatment case study. The Hemopurifier® is the first medical device
to target the treatment of both HIV and HCV, as well as a broad-spectrum
of other infectious viral pathogens.
