Aethlon Medical, Inc. Announces Positive Data Safety Monitoring Board Review and Recommendation to Advance to Next Clinical Trial Cohort

Core Viewpoint - Aethlon Medical, Inc. has received a positive recommendation from the independent Data Safety Monitoring Board (DSMB) to advance its clinical trial of the Aethlon Hemopurifier without modifications, indicating a favorable safety profile for the device in oncology applications [1][3][4]. Group 1: Clinical Trial Details - The ongoing trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab," aims to evaluate the safety, feasibility, and optimal dosing of the Hemopurifier [2]. - The DSMB reviewed data from the initial cohort of three participants, each receiving a single 4-hour treatment, and found no safety concerns, confirming the Hemopurifier's favorable safety and tolerability profile [3]. - Enrollment for the second cohort is now open, where participants will receive two Hemopurifier treatments over a one-week period, with the trial aiming to enroll approximately 9 to 18 patients [4]. Group 2: Study Objectives and Endpoints - The primary endpoint of the trial is to monitor the incidence of adverse events and clinically significant changes in safety laboratory tests among Hemopurifier-treated patients [5]. - The study will also examine the number of Hemopurifier treatments needed to decrease the concentration of tumor-derived extracellular vesicles (EVs) and assess if these changes improve the body's ability to attack tumor cells [5]. Group 3: Device Information - The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation, utilizing a combination of plasma separation, size exclusion, and affinity binding [7]. - The device has received U.S. Food and Drug Administration Breakthrough Device designation and is being developed under an open Investigational Device Exemption for its oncology and infectious disease indications [8]. Group 4: Company Commitment - Aethlon Medical remains committed to advancing the Hemopurifier for oncology applications and will continue to provide updates as the clinical trial progresses [6].