Aethlon Medical Hemopurifier cancer trial in India approved by ethics committee

Aethlon Medical announced that, on September 9, the Medanta Institutional Ethics Committee – MIEC – granted full ethics approval for Aethlon’s safety, feasibility and dose-finding clinical trial of the Hemopurifier in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda or Opdivo. The approval is valid for one year, followed by annual reviews. This trial has previously been reviewed by the Institutional Review Board at Medanta. Additionally, the company previously received a No Objection Certificate from DCGI for the proposed oncology trial. The primary endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial is safety. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval, study required by regulatory agencies.