Aethlon Medical Completes Human Safety Study of Hemopurifier
Posted on: Wednesday, 15 October 2008, 03:00 CDT
Aethlon Medical, a developmental-stage medical device company, has completed a human safety study conducted at the Fortis Hospital in Delhi, India. The primary objective of the study was to evaluate the safety of the Aethlon Hemopurifier in health compromised end-stage renal disease patients that require kidney dialysis.
In the study, six end-stage renal disease (ESRD) patients received a series of three, four-hour Hemopurifier treatments every other day during the course of one week. The treatment regimen mirrored the patient's normal kidney dialysis schedule, which allowed for the inclusion of the Hemopurifier without disrupting dialysis treatment.
Blood chemistry and general health of the patients were monitored throughout the study, and at the conclusion of the study, the sole reported adverse event was hemolysis, which was observed in a total of four treatments, three of which occurred in the same patient.
The physicians administering the study reported that the incidence of hemolysis did not cause any follow-on health concerns. No other adverse events have been reported in a total of 42 Hemopurifier treatments administered in human studies.
The Hemopurifier is a first-in-class medical device that assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins, said Aethlon. In addition to demonstrating safety, the study provided the opportunity to observe changes in viral load in ESRD patients infected with hepatitis-C virus (HCV).
James Joyce, chairman and CEO of Aethlon, said: "With the Fortis study complete, we will update our investigational device exemption on file with the FDA and request permission to initiate human studies in the US. Additionally, we are preparing to launch a four-week HCV treatment case study that could trigger early commercialization in India, and we have initiated discussions with potential partners to evaluate the clinical opportunity for our Hemopurifier in the EU."
Source: Datamonitor
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