Aethlon Medical has achieved a significant milestone in its Australian clinical trial by successfully treating a second patient with its investigational Hemopurifier device on June 11, 2025, at Royal North Shore Hospital/University of Sydney. The safety, feasibility, and dose-finding trial targets patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment with Keytruda (pembrolizumab) or Opdivo (nivolumab).
Trial Progress and Safety Profile
Both patients in the first cohort have now completed their 4-hour Hemopurifier treatments without device deficiencies or immediate complications. The first participant was treated at Royal Adelaide Hospital on January 29, 2025, while the second received treatment at Royal North Shore/University of Sydney on June 2, 2025. As of June 10, 2025, both patients completed the pre-specified 7-day safety follow-up period.
"We are pleased that both patients treated with the Hemopurifier thus far have tolerated the 4-hour treatment without immediate complications. We look forward to enrolling the third participant to trigger a safety review of the first cohort by the DSMB," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical.
The independent Data Safety Monitoring Board (DSMB) will review safety data following treatment of a third patient in the cohort and provide recommendations about advancing to the second treatment cohort, where three participants will receive two Hemopurifier treatments during a one-week period.
Addressing Immunotherapy Resistance
The trial addresses a significant clinical challenge: currently, only approximately 30-40% of patients who receive pembrolizumab or nivolumab achieve lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in cancer spread and resistance to anti-PD-1 therapies.
The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, potentially improving therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier demonstrated the ability to reduce the number of exosomes from plasma of cancer patient samples.
Trial Design and Endpoints
The approximately 18-patient trial's primary endpoint is the incidence of adverse events and clinically significant changes in safety lab tests of Hemopurifier-treated patients with solid tumors showing stable or progressive disease at different treatment intervals. Patients undergo a two-month run-in period of PD-1 antibody monotherapy before becoming eligible for the Hemopurifier treatment phase.
Sequential cohorts will receive 1, 2, or 3 Hemopurifier treatments during a one-week period. Beyond safety monitoring, the study examines the number of treatments needed to decrease EV concentrations and whether these changes improve the body's natural ability to attack tumor cells. Data on extracellular removal and effects on anti-tumor T cell activity are expected approximately three months following enrollment of the third patient.
Device Technology and Regulatory Status
The Hemopurifier is an extracorporeal device used with a blood pump that incorporates plasma separation, size exclusion, and affinity binding to an affinity resin containing plant lectin. Mannose on the surface of enveloped viruses and extracellular vesicles binds to the plant lectin within the device.
The device holds U.S. Food and Drug Administration Breakthrough Device designation for treating individuals with advanced or metastatic cancer who are unresponsive to or intolerant of standard-of-care therapy. It also maintains an open Investigational Device Exemption (IDE) application for treating life-threatening viruses not addressed with approved therapies.
The exploratory analyses from this trial are expected to inform the design of a subsequent efficacy and safety Premarket Approval (PMA) study required by regulatory agencies. Professor Stephen Clarke serves as Principal Investigator, with Dr. Emma O'Lone supervising the Hemopurifier sessions.
