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Aethlon Medical Reports Immediate and Rapid Virologic Responses in Hepatitis C (HCV) Patients Receiving Hemopurifier® Treatment Protocol
Date:2/1/2012

device-related adverse events during the Hemopurifier® + PR treatment period.  At present, the reported data of the Extract-1 study is not statistically significant and should be considered preliminary.  Changes in HCV RNA levels are measured with the Roche Cobas TaqMan assay, which has a quantification limit of 15 IU per milliliter (iu/ml).  In addition to measuring changes in HCV RNA, the Extract-1 study protocol will quantify the amount of HCV captured within Hemopurifier® treatment cartridges.  The goal of PR treatment is to establish a sustained virologic response (SVR), defined as undetectable HCV RNA 24 weeks after completion of therapy.  Primary clinical endpoints of the Extract-1 study measure the impact of Hemopurifier® therapy during the initial phase of PR therapy.  Each clinical endpoint is based on changes in HCV RNA from baseline viral load measurements taken prior to Hemopurifier® + PR therapy initiation.  These endpoints include:

Day Three (3):  the change in HCV RNA from baseline to the end of the Hemopurifier® + PR treatment phase;

Day Seven (7): the change in HCV RNA 7 days from initial baseline.  A drop of HCV RNA greater than 2 logs at day 7 is known as an Immediate Virologic Response (IVR). Based on the landmark IDEAL Study of 3,070 HCV genotype-1 patients receiving PR therapy, IVR achievement correlates with 90+% SVR rates, yet is observed in less than 5% of patients;

Day 30: the change in HCV RNA 30 days from initial baseline. Undetectable HCV RNA at day 30 is known as a Rapid Virologic Response (RVR). Based on the IDEAL Study, RVR achievement correlates with an SVR likelihood of 86.2%, which is observed in only 10.35% of patients.

Day 3 Results

Patient E-1.03: Baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840 IU/ml when measured on day 3, representing a 3.49 log reduction.  HCV RNA reduction during the 3-day Hemopurifier®
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SOURCE Aethlon Medical, Inc.
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