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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