Aethlon Medical Kicks Off Cancer Trial at Royal Adelaide Hospital
Aethlon Medical, Inc. (Nasdaq: AEMD) has just announced a significant milestone: the activation of the Cancer Clinical Trial Unit at Royal Adelaide Hospital. This development enables the hospital to begin screening and enrolling patients for a clinical trial focused on the Hemopurifier®, an innovative treatment aimed at patients with solid tumors who haven’t had success with anti-PD-1 antibodies.
Trial Overview
The trial is constructed as a safety, feasibility, and dose-finding study particularly targeting patients currently on anti-PD-1 monotherapy, such as Keytruda® and Opdivo®. Officially titled the AEMD-2022-06 Hemopurifier Study, it seeks to evaluate the safety and effectiveness of the Hemopurifier in individuals whose disease is either stable or progressing.
Led by Prof. Michael Brown alongside his skilled team at the Royal Adelaide Hospital, this trial offers Aethlon Medical a vital chance to collect data that could greatly enhance treatment outcomes for cancer patients.
Importance of the Activation
Activating the Royal Adelaide Hospital as a trial site came after receiving approval from the Human Research Ethics Committee at Central Adelaide Local Health Network. The required governance notifications have been completed, which facilitated a smooth setup and start to patient recruitment.
Dr. Steven LaRosa, Chief Medical Officer at Aethlon Medical, expressed excitement about reaching this milestone, highlighting the collaborative efforts with Prof. Brown and the devoted team. Furthermore, the company has plans to establish additional clinical sites, including one in India, expanding their research outreach.
Getting to Know the Hemopurifier
Only about 30% of patients treated with approved anti-PD-1 therapies experience durable responses, revealing a critical need for improved treatment options. The Hemopurifier is specifically designed to target and eliminate extracellular vesicles (EVs) that tumors release into the bloodstream, which may fuel cancer growth and treatment resistance.
Preclinical research suggests that this groundbreaking device can significantly lower the levels of exosomes found in the plasma of cancer patients, potentially boosting their responses to existing therapies. This clinical trial will focus on monitoring the occurrence of adverse events and notable changes in safety lab test results.
Trial Design and Objectives
The trial will include around 18 patients, examining the overall safety and feasibility of using the Hemopurifier in those with solid tumors. During the study, eligible patients already receiving anti-PD-1 therapy will be given the chance to enter the Hemopurifier treatment phase, where they will undergo three distinct treatment intervals.
The study also aims to clarify how the removal of EVs through the Hemopurifier can boost the body's natural ability to fight off tumor cells. Comprehensive laboratory analyses will provide essential insights that will influence the design of future efficacy and safety trials, with the ultimate goal of obtaining regulatory approval.
About Aethlon Medical
Aethlon Medical, Inc. is committed to creating cutting-edge treatments through its Hemopurifier technology. This advanced immunotherapeutic device aims not only to combat cancer but also to address life-threatening viral infections. The product is notable for its ability to eliminate harmful exosomes from the body, which can lead to immune suppression and cancer progression.
With its designation as a Breakthrough Device by the FDA, the Hemopurifier represents a significant hope for patients who do not respond to current treatments or who find standard care options intolerable.
Frequently Asked Questions
What is the purpose of Aethlon Medical's trial?
The trial aims to assess the safety and effectiveness of the Hemopurifier for patients with solid tumors who aren't responding to anti-PD-1 therapies.
Who is leading the clinical trial?
Prof. Michael Brown and his team at the Cancer Clinical Trials Unit at Royal Adelaide Hospital are overseeing the trial.
What is the function of the Hemopurifier?
The Hemopurifier is designed to capture and eliminate extracellular vesicles from the bloodstream, potentially improving responses to cancer treatments.
How many patients are expected to participate in the trial?
The clinical trial plans to enroll about 18 patients for this safety and feasibility study.
What outcomes does the trial aim to achieve?
The trial intends to evaluate safety, the occurrence of adverse events, and how effectively the Hemopurifier can enhance patient responses to existing therapies.
