Aethlon Medical Launches Cancer Trial at Royal Adelaide Hospital
Aethlon Medical Launches Cancer Trial at Royal Adelaide Hospital
Aethlon Medical, Inc. (Nasdaq: AEMD) recently announced the activation of the Cancer Clinical Trial Unit at Royal Adelaide Hospital. This pivotal step allows the institution to start screening and enrolling patients in a clinical trial focusing on the Hemopurifier®, an innovative therapeutic approach targeting patients with solid tumors who are not responding to anti-PD-1 antibodies.
Trial Overview
The trial is designed as a safety, feasibility, and dose-finding study, specifically aimed at patients undergoing anti-PD-1 monotherapy, like Keytruda® and Opdivo®. This study, known as the AEMD-2022-06 Hemopurifier Study, aims to analyze the safety and efficacy of the Hemopurifier in individuals with stable or progressive diseases.
Conducted by Prof. Michael Brown and his expert team at the Royal Adelaide Hospital, the trial represents a crucial opportunity for Aethlon Medical to gather data that may significantly improve treatment responses in cancer patients.
Significance of the Activation
The activation of the Royal Adelaide Hospital as a trial site follows the approval from the Human Research Ethics Committee at Central Adelaide Local Health Network. The necessary governance notifications were completed, allowing for an efficient setup and initiation of patient recruitment.
Dr. Steven LaRosa, Chief Medical Officer of Aethlon Medical, expressed enthusiasm about this milestone, emphasizing the collaborative efforts with Prof. Brown and the dedicated staff. The company is also planning to activate additional clinical sites, including one in India, further extending their research capacity.
Understanding the Hemopurifier
Currently, only about 30% of the patients treated with approved anti-PD-1 therapies manage to achieve durable responses, underscoring the need for enhanced treatment options. The Hemopurifier has been invented specifically to target and remove extracellular vesicles (EVs) that tumors release into the bloodstream, which may contribute to cancer proliferation and treatment resistance.
Preclinical studies demonstrate that this innovative device can effectively reduce the concentration of exosomes present in cancer patients' plasma, potentially enhancing their response to existing therapies. The focus of this clinical trial is to monitor the incidence of adverse events and significant changes in safety lab test results.
Trial Design and Goals
The trial incorporates approximately 18 patients, assessing the overall safety and feasibility of using the Hemopurifier in solid tumor patients. During the trial, eligible patients currently receiving anti-PD-1 therapy will have the opportunity to enter the Hemopurifier treatment phase, where they will receive three potential treatment intervals.
This study also aims to elucidate how the removal of EVs through the Hemopurifier can elevate the body's natural capacity to combat tumor cells. Central laboratory analyses will play a significant role in guiding the design of subsequent efficacy and safety studies, aiming for eventual regulatory approval.
About Aethlon Medical
Aethlon Medical, Inc. is dedicated to developing innovative treatments via its Hemopurifier technology. This advanced immunotherapeutic device not only aims to fight cancer but also tackles life-threatening viral infections. The product is distinguished by its ability to eliminate harmful exosomes from the body, which can contribute to immune suppression and the progression of cancer.
Following its designation as a Breakthrough Device by the FDA, the Hemopurifier illustrates great promise for patients who are either unresponsive to current treatments or intolerant of standard care options.
Frequently Asked Questions
What is the purpose of Aethlon Medical's trial?
The trial aims to evaluate the safety and efficacy of the Hemopurifier in patients with solid tumors not 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 conducting the trial.
What is the Hemopurifier designed to do?
The Hemopurifier is designed to bind and remove extracellular vesicles from the bloodstream, potentially improving therapeutic responses to cancer treatments.
How many patients will be involved in the trial?
The clinical trial is expected to enroll approximately 18 patients for this safety and feasibility study.
What are the expected outcomes of the trial?
The trial aims to assess safety, incidence of adverse events, and how effectively the Hemopurifier can enhance patients' responses to existing therapies.
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