Aethlon Medical Begins Hemopurifier® Cancer Trial in Australia with First Patient Enrollment

Aethlon Medical, Inc. (Nasdaq: AEMD) has enrolled the first patient in its Australian safety, feasibility, and dose-finding trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 therapy with pembrolizumab (Keytruda®) or nivolumab (Opdivo®). Conducted at the Cancer Clinical Trials Unit at CALHN, Royal Adelaide Hospital, this trial represents a critical step in evaluating the Hemopurifier’s potential to enhance the effectiveness of anti-PD-1 therapies.

Currently, only approximately 30% of patients treated with pembrolizumab or nivolumab achieve lasting clinical responses. Tumor-produced extracellular vesicles (EVs) have been implicated in cancer progression and resistance to anti-PD-1 therapies. The Aethlon Hemopurifier is designed to bind and remove these EVs from the bloodstream, potentially improving therapeutic response rates. In preclinical studies, the Hemopurifier demonstrated a capacity to reduce exosome concentrations from the plasma of cancer patients.

Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical commented, “Enrollment of the first patient represents the achievement of a critical milestone for Aethlon Medical in the clinical development of the Hemopurifier in Oncology. We are thrilled with the pre-screening activity being done to identify patients at Royal Adelaide, as well as the second site, Pindara Private Hospital in the Gold Coast . We are grateful to the patient for consenting to be part of this study. This trial is our initial step in determining if the Hemopurifier treatment can improve upon the 30-40% response rates to anti-PD-1 therapies such as Opdivo and Keytruda.”

The trial includes a two-month run-in period of continued anti-PD-1 therapy to assess baseline EV concentrations and anti-tumor T cell activity. Eligible patients will then receive Hemopurifier treatments, with safety, changes in EV concentrations, and anti-tumor immune responses monitored to evaluate the potential enhancement of immune activity against tumors.