10th Patient Treated in Extract-1 Study
Brian Marckx, CFA
This morning Aethlon Medical (AEMD) reported that ten patients have been treated to-date in their Extract-1 study. 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 company's 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 is expected to 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.
Clinical endpoints of Extract-1 include;
- at day 3, the change in HCV RNA from baseline (day 3 is the end of the Hemopurifier plus peginterferon/ribavarin treatment)
- at day 7, the change in HCV RNA from baseline. HCV RNA decrease of more than 2 logs at day seven is called an Immediate Virologic Response (IVR) - large HCV studies have shown that 90% or more patients that reach IVR will achieve Sustained Virologic Response (i.e. - clinical cure). IVR is typically achieved in only about 5% of patients treated with only peginterferon/ribavarin (we note, however, that many people that fail to achieve IVR do achieve SVR. SVR is typically achieved in approximately 40% of HCV patients treated with peginterferon/ribavarin)
- at day 30, the change in HCV RNA from initial baseline. Undetectable HCV RNA at day 30 is called a Rapid Virologic Response (RVR) - large HCV studies have shown that over 85% of patients that reach RVR will achieve Sustained Virologic Response (:SVR). RVR is typically achieved in only about 10% of patients treated with only peginterferon/ribavarin (again, we note that failure to hit these early response milestones does not necessarily predict eventual failure to achieve clinical cure as SVR is typically achieved in approximately 40% of HCV patients treated with peginterferon/ribavarin)
In February Aethlon reported data on the first three patients treated, indicating effectiveness in reducing HCV load through the 3-day Hemopurifier treatment phase. IVR (undetectable viral load at 7 days) was achieved in 1 of the 3 patients and RVR (undetectable viral load at 30 days) was achieved in 2 of the 3 patients, with the third almost achieving RVR.
Then in May Aethlon reported that nine patients (six of which were infected with genotype-1 HCV) had been treated, seven of which had been followed for 90 days or more (including three for 48 weeks) and had undetectable viral load. Specifics on the trial endpoints (change in HCV RNA from baseline to days 3, 7, and 30) were not offered.
This morning's press release notes that ten patients (six of which were infected with genotype-1 HCV) have now been treated, the two most recent of which achieved IVR. Aggregate results of all ten patients on the three efficacy endpoints was not offered although Aethlon does note that four of the six (67%) genotype-1 patients have achieved RVR (undetectable viral load at 30 days). Relative to data from large HCV studies (as referenced above), this RVR rate indicates that Hemopurifier may be having a positive effect on reducing HCV load.
Earlier in the year Aethlon submitted a request to the Medicity IRB for 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. A response is pending. Aethlon is also looking to open up treatment to individuals outside of India. The company also notes that they are preparing to resubmit an IDE which will incorporate this Medicity data, seeking approval to initiate U.S. clinical trials.
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