By M. Marin
NASDAQ:AEMD
READ THE FULL AEMD RESEARCH REPORT
Cohort 2 participants being treated, with queue building for patient participation in trial
Aethlon Medical (NASDAQ:AEMD) announced FY 3Q (quarter ended December 31, 2025) results and provided a business update last week. The company’s primary focus is on researching lead asset, the Hemopurifier® therapeutic blood filtration system, as a potential treatment in oncology. The Hemopurifier is an investigational extracorporeal device designed to bind and remove harmful extracellular vesicles (EVs), nanoparticles 50-500nm in diameter, from the blood through a combination of plasma separation, size exclusion, and binding to a proprietary affinity resin. The device has received FDA Breakthrough Device designation for the treatment of people with advanced or metastatic cancer who are either unresponsive to or cannot tolerate standard of care therapy, and with cancer types in which exosomes are indicated in the development or severity of the disease, and also for life-threatening viruses that are not addressed with approved therapies.
AEMD is conducting a basket oncology trial to study the impact of the Hemopurifier as a potential treatment in patients with various solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, and is advancing the trial. Unfortunately, only about 30% of cancer patients who receive pembrolizumab (Keytruda®) or nivolumab (Opdivo®) treatment for solid tumors have lasting clinical responses. The company’s hypothesis is that using the Hemopurifier in conjunction with treatment of checkpoint inhibitors and/or combination therapy can increase the percentage of patients who can benefit, and early data looks promising. The trial is intended to assess the Hemopurifier's safety, feasibility, and optimal dosing.
Cohort 2 recruitment facilitated by engagement of Trialfacts
Following treatment of the first three patients (Cohort 1), who completed a single 4-hour Hemopurifier treatment without device deficiencies or immediate complications, the study design is for Cohort 2 participants to receive two Hemopurifier treatments over one week to help determine whether there is a dose response with additional Hemopurifier treatments.
To accelerate enrollment, AEMD is working with clinical trial facilitator Trialfacts to perform clinical trial advertising, online prescreenings, and refer potential participants to the three sites in Australia participating in the trial. AEMD attributes the queue of oncology patients interested in participating in the trial to Trialfacts’ efforts. In addition, Cohort 2 recruitment and treatment are being conducted under an amended protocol that allows patients receiving combination therapies with pembrolizumab or nivolumab to participate in the AEMD trial.
Expect Cohort 2 early data, Safety Board determination by late March/early April
All Cohort 1 participants also completed a 7-day safety follow-up. No serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported to date. The company expects to report early data from Cohort 2 and receive Safety Board determination about progressing to Cohort 3 (or potentially treating additional Cohort 2 patients) by late March/early April.
AEMD recently reported early preliminary data from Cohort 1 and is recruiting participants for Cohort 2. Data from Cohort 2, as well as Cohort 3, subsequently, as the study progresses, will help determine whether the positive observations from Cohort 1 (see below) can be reproduced and also whether additional Hemopurifier treatments produce a dose response in terms of the magnitude and duration of changes. In other words, the study is designed to examine whether an increased number of Hemopurifier treatments can help extend positive patient responses. The company’s goal is to build its database supporting development of the Hemopurifier as an oncology treatment, and this data appears to support that goal.
Evaluating potential of using the Hemopurifier with a simplified blood treatment system to support broader potential clinical application
Currently, Hemopurifier treatment requires a dialysis catheter and dialysis machine, and nephrologists and dialysis nurses to supervise and administer the treatment. Importantly, to potentially make it easier for medical centers and patients down the road if the Hemopurifier gains adoption, AEMD has started to evaluate the potential of using the Hemopurifier with a simplified blood treatment system that could replace the use of dialysis infrastructure.
This research potentially could lead to a simplified system for performing Hemopurifier treatments in oncology units in the future using a PICC (peripherally inserted central catheter) line. A PICC catheter is less invasive compared to a larger dialysis catheter, so this potential change could make it easier for the patient by eliminating the need to go to dialysis equipment generally located in a different area than the oncology team and inserting a smaller, less invasive line to connect the patient to the device. If the company can move to this delivery system of Hemopurifier treatment, it could prove to be transformational for the ease of using the device as an oncology treatment, we believe.
Cost-efficient measures to study Hemopurifier as a potential treatment in other indications & raise awareness in the scientific community
While AEMD’s primary focus is on researching the Hemopurifier as a potential treatment in oncology, the company believes the Hemopurifier could have significantly broader applications. AEMD is developing a pipeline of indications for the device in a highly cost-efficient way. AEMD has submitted research papers to peer-reviewed journals, presented a poster at a recent medical conference, and increased its attendance at medical meetings when appropriate, among other measures to raise awareness of the device and its potential benefits in the scientific community.
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