Aethlon Medical’s independent Data Safety Monitoring Board completed its scheduled review of cohort two data in the AEMD-2022-06 trial and recommended progression to the third cohort after finding no serious adverse events or dose-limiting toxicities related to the Hemopurifier device or procedure.

In cohort three, enrollment is now open at three sites in Australia for nine to eighteen patients with stable or progressive solid tumors receiving Pembrolizumab or Nivolumab; participants will undergo three Hemopurifier treatments over a one-week period to evaluate safety, feasibility and optimal dosing parameters, including incidence of adverse events and changes in safety laboratory tests.

The investigational Hemopurifier device combines plasma separation, size exclusion and affinity binding to remove tumor-derived extracellular vesicles and enveloped viruses from circulation; findings on EV reduction will inform the design of a future efficacy and safety Premarket Approval study required by regulatory authorities.