Aethlon Medical Receives Ethics Committee Approval for Hemopurifier® Cancer Trial

Core Viewpoint - Aethlon Medical has received full ethics approval for a clinical trial of its Hemopurifier® device aimed at cancer patients with solid tumors who are not responding to anti-PD-1 therapies, marking a significant milestone for the company [1][3]. Group 1: Clinical Trial Details - The Human Research Ethics Committee of the Central Adelaide Local Health Network approved the trial on June 13, 2024, which is valid for three years until June 13, 2027 [1]. - The trial will be conducted by Prof. Michael Brown at the Cancer Clinical Trials Unit, Royal Adelaide Hospital, and will focus on safety, feasibility, and dose-finding [1][3]. - The primary endpoint of the trial is safety, monitoring adverse events and lab test changes in approximately 18 patients with stable or progressive disease after a two-month run-in period of PD-1 antibody therapy [3]. Group 2: Mechanism and Rationale - Only about 30% of patients receiving pembrolizumab or nivolumab experience lasting clinical responses, with extracellular vesicles (EVs) from tumors contributing to cancer spread and resistance to therapies [2]. - The Hemopurifier is designed to bind and remove these EVs from the bloodstream, potentially improving therapeutic response rates to anti-PD-1 antibodies [2]. Group 3: Future Steps and Regulatory Path - Following the ethics approval, the company plans to submit to the Therapeutic Goods Administration and obtain approval from the CALHN Research Governance Committee [3]. - The company also intends to submit to additional Ethics Committees in Australia and India to facilitate further patient enrollment [3]. Group 4: Company Overview - Aethlon Medical focuses on developing the Hemopurifier, a clinical stage immunotherapeutic device aimed at treating cancer and life-threatening viral infections [4]. - The Hemopurifier has shown promise in removing harmful exosomes and life-threatening viruses, with FDA designations as a Breakthrough Device for advanced or metastatic cancer treatment [4].