Aethlon Medical, Inc. (Nasdaq: AEMD) has announced the treatment of the first patient in its Australian clinical trial evaluating the Hemopurifier device. The trial, conducted at the Cancer Clinical Trials Unit, Royal Adelaide Hospital, is a safety, feasibility, and dose-finding study in patients with solid tumors who have not responded to anti-PD-1 therapies such as pembrolizumab or nivolumab.
The first patient, enrolled on October 29, 2024, underwent a two-month run-in period on nivolumab. Following confirmation of disease progression, the patient received a four-hour Hemopurifier treatment on January 29, 2025, and tolerated the procedure without complications. Subsequent follow-up visits will monitor safety, EV levels, T cell activity, and clinical response.
Rationale for Hemopurifier Treatment
Currently, only 30-40% of patients achieve lasting clinical responses to anti-PD-1 therapies. Tumor-derived extracellular vesicles (EVs) have been implicated in cancer spread and resistance to these therapies. The Hemopurifier is designed to remove these EVs from the bloodstream, potentially enhancing the effectiveness of anti-PD-1 antibodies. Preclinical studies have demonstrated the Hemopurifier's ability to reduce exosomes in plasma from cancer patients.
Trial Design and Endpoints
The trial aims to enroll approximately 18 patients to assess the safety, feasibility, and optimal dosing of the Hemopurifier. Patients receive one, two, or three Hemopurifier treatments over a week after failing to respond to PD-1 antibody monotherapy. The primary endpoint is the incidence of adverse events and clinically significant changes in safety lab tests. Secondary endpoints include changes in EV concentrations and their impact on the body's ability to attack tumor cells. These exploratory analyses will inform the design of future efficacy and safety studies for regulatory approval.
About the Hemopurifier
The Aethlon Hemopurifier is an investigational device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation. It is an extracorporeal device used with a blood pump, incorporating plasma separation, size exclusion, and affinity binding to a plant lectin resin. The device has received FDA Breakthrough Device designation for advanced or metastatic cancer patients unresponsive to standard care and for life-threatening viruses lacking approved therapies.
Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical, stated, "Treatment of the first patient represents the achievement of a critical milestone for Aethlon Medical in the clinical development of the Hemopurifier in Oncology," and expressed excitement about receiving data from this first treatment cohort, anticipating insights into how the Hemopurifier may reduce tumour-derived extracellular vesicles and enhance T cell activity against tumours."
