Aethlon Medical Inc (AEMD)

[philife]

Abstract from Conference today

[F-PO1484] Safety & Efficacy of Hemopurifier Treatment for HCV Positive Dialysis Patients

Vijay K. Kher, Puneet Sodhi, S. Pokhariyal, M. Singhal, Richard Tullis, Harold Handley, R. Paul Duffin Nephrology, Fortis Hospital, New Delhi, India; Aethlon Medical Inc., San Diego, CA

Methods
An ERB approved safety and efficacy study of the use of Hemopurifier was undertaken in 10 HCV positive MHD patients not receiving IFN treatment. The trial consisted of 1 week of control period (HD thrice a week for 4 hrs each), 1 to 2 weeks of treatment (Hemopurifier in series with hemodialyzer thrice a week for 4 hrs) and 1 week of follow up period (thrice a week HD 4 hrs each). A physical examination, hematology, clinical chemistry, and HCV quantitation using qRT-PCR were performed pre and post dialysis to monitor safety and efficacy. HCV capture inside the Hemopurifier cartridge was measured randomly in 5 cartridges. 1 patient underwent an additional 30 day Hemopurifier treatment (4 hr thrice a week for four weeks) to study the effect of prolonged treatment on safety and HCV viral load.
Results
Hemopurifier treatment resulted in an average net viral load reduction of 41% per 4 hrs treatment (2.11 x 107 iu/ml post treatment vs 3.58 x 107 iu/ml pretreatment). In 5 Extracted cartridges HCV capture averaged 8.9 x 108 copies/cartridge (30% of the initial viral burden of HCV). In the one week studies, an 85% viral load reduction was observed at the end of the last treatment. After one week of follow-up viral load remained 75% reduced while a sustained reduction of 8% was seen beyond the Hemopurifier treatment in the 30 day treated patient. Physical examination, hematological and chemical parameters monitored pre and post sessions did not reveal any significant changes relative to controls. 4 episodes of minor hemolysis in 2 patients were noticed related to the device. This was controlled by reduction of blood flow to 250 ml/min. One patient had severe nausea and shivering during one session. Eleven additional adverse events not related to the device were observed, primarily shivering and nausea. No GNA leaching was observed.
Conclusions
Hemopurifier treatment with HD was safe when performed at flow rates of 250 ml/min. Hemopurifier treatment results in 41% HCV Viral load reduction after 4 hr treatment and progressive HCV viral load reduction after longer duration of treatment.

Friday, October 30, 2009 10:00 AM

Poster Session: Dialysis: Epidemiology, Outcomes, and Clinical Trials: Non-Cardiovascular II (10:00 AM-12:00 PM) Poster Board Number: F-PO1484

Location: Exhibit Halls A/B/C

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