90-Day Data Looks Positive
This morning (5/8/12)
Aethlon (
AEMD
)
reported additional results from its Extract-1 study, further
supporting that Hemopurifier is having a positive effect in
reducing HCV viral load and in achieving sustained virological
response.
The goal of the study, officially titled
Use of the Aethlon Hemopurifier in Treating Chronic HCV
Infection in Combination with Standard of Care Drug Therapy,
is to show that the Hemopurifier is able to safely and effectively
accelerate viral load depletion of HCV when used during the first
three days of standard of care drug therapy
(peginterferon/ribavarin). The study will enroll up to 30
patients with HCV (of various genotypes including hard-to-treat
genotype-1) which receive six-hour applications of Hemopurifier
during the first three days of peginterferon/ribavarin
therapy. On day one peginterferon/ribavarin therapy is
initiated within one hour of first Hemopurifer therapy
completion. Hemopurifier therapy is then administered again
once daily for the next two days in combination with
peginterferon/ribavarin therapy.
Aethlon had previously (February) reported results on the first
three patients 30 days after treatment which suggested that
Hemopurifier may be having a positive effect on rapidly reducing
HCV RNA. This morning's press release cites results of all
nine patients that have been treated to date, seven of which have
been followed for 90 days. Six of the nine patients were
infected with genotype-1 HCV. All seven of the patients
monitored for 90 days have maintained undetectable viral load,
including three patients that have been monitored for 48
weeks. Sustained virological response (SVR), or clinical
cure, is defined as undetectable viral load at 24 weeks.
Safety continues to be good with no device related adverse events.
Aethlon has requested permission to increase frequency of treatment
to seven days in the Extract-1 study which the company believes
will show even more rapid viral load reduction. Aethlon is
also looking to open up treatment to individuals outside of
India.
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