AEMD: Initial Virus Capture Data
Brian Marckx, CFA
In a press release this morning (4/24) Aethlon Medical (AEMD) announced preliminary data related to the capture of HCV virus in the Hemopurifier cartridge. As a reminder, in a July 2011 meeting with the FDA to discuss what the agency might be looking for in an eventual Investigational Device Exemption (IDE) application, the agency inquired about the ability of the Hemopurifier to measure the quantity of HCV virus captured. Based on the FDA's comments, Aethlon decided to include this data point into the study protocol for the Extract-1 study - which, assuming positive results, will be used as additional support for an eventual IDE application for approval for U.S. trials.
This morning's press release notes that data from three cartridges has been analyzed for amount of HCV virus captured after a single six-hour treatment. Also noted was that two of the three cartridges were cracked prior to being evaluated. The cartridge that remained fully intact showed virus capture of 3 billion copies of HVC. The two cracked cartridges, in which the integrity of the virus capture data may have been compromised, showed capture of 145 million and 353 million copies of HCV.
While its difficult to judge the clinical significance of this data, it does clearly show that the Hemopurifier is capturing the HCV virus.
Extract-1 Preliminary Results (see our March 13, 2012 report for our discussion of the data)
Aethlon had previously (February 1) announced preliminary results from the first three patients of Extract-1. The patients received three, 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. The Hemopurifier treatment was well tolerated without any device-related adverse events. Results of each clinical endpoint from these three patients were;
Day 3: Baseline HCV RNA fell: in patient 1 from 5,800,000 IU/ml to 1,840 IU/ml equal to 3.49 logs, in patient 2 from 199,500 IU/ml to 31,550 IU/ml equal to 0.80 logs, and in patient 3 from 1,340,000 IU/ml to 54,900 IU/ml equal to 1.38 logs
Day 7: One of the three patients achieved IVR. Baseline HCV RNA fell: in patient 1 from 5,800,000 IU/ml to 234 IU/ml equal to 4.39 logs, in patient 2 from 199,500 IU/ml to 17,300 IU/ml equal to 1.06 logs, and in patient 3 from 1,340,000 IU/ml to 24,400 IU/ml equal to 1.74 logs
Day 30: Two of the three patients achieved RVR, with the third almost achieving RVR. RVR is typically achieved in only about 10% of HCV patients treated with only peginterferon/ribavarin. Baseline HCV RNA fell: in patient 1 from 5,800,000 IU/ml to undetectable (<15 IU/ml) equal to 5.58 logs, in patient 2 from 199,500 IU/ml to 40 IU/ml (i.e. - virtually undetectable) equal to 3.69 logs, and in patient 3 from 1,340,000 IU/ml to undetectable equal to 4.95 logs
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