Aethlon Medical, Inc. (Nasdaq: AEMD) has announced the activation of the Cancer Clinical Trial Unit at Royal Adelaide Hospital on September 10, 2024, to commence screening and enrollment for its clinical trial evaluating the Hemopurifier® in patients with solid tumors. This trial focuses on individuals who have experienced stable or progressive disease despite undergoing anti-PD-1 monotherapy treatments, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab).
The AEMD-2022-06 Hemopurifier Study, led by Prof. Michael Brown and his team at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia, follows approvals from the Human Research Ethics Committee at Central Adelaide Local Health Network and the Research Governance office at Royal Adelaide Hospital, as well as notification to the Therapeutic Goods Administration (TGA).
Addressing Resistance to Anti-PD-1 Therapies
Currently, only about 30% of patients treated with pembrolizumab or nivolumab exhibit lasting clinical responses. Research suggests that extracellular vesicles (EVs) produced by tumors contribute to cancer spread and resistance to anti-PD-1 therapies. The Hemopurifier is designed to bind and remove these EVs from the bloodstream, potentially enhancing the effectiveness of anti-PD-1 antibodies. Preclinical studies have indicated that the Hemopurifier can reduce the number of exosomes in plasma samples from cancer patients.
Trial Design and Endpoints
The trial is designed as a safety, feasibility, and dose-finding study involving approximately 18 patients. The primary endpoint is the incidence of adverse events and clinically significant changes in safety lab tests in Hemopurifier-treated patients with solid tumors showing stable or progressive disease. This assessment will occur after a two-month run-in period of PD-1 antibody monotherapy with Keytruda® or Opdivo®. Patients who do not respond to the initial therapy will be eligible for the Hemopurifier phase of the study. Sequential cohorts will receive one, two, or three Hemopurifier treatments within a one-week period.
In addition to safety monitoring, the study aims to determine the number of Hemopurifier treatments required to decrease EV concentration and whether these changes improve the body's ability to attack tumor cells. These exploratory analyses are expected to inform the design of a subsequent efficacy and safety study for Premarket Approval (PMA) required by regulatory agencies.
Aethlon's Hemopurifier Technology
Aethlon Medical is focused on developing the Hemopurifier, an immunotherapeutic device in clinical stages, designed to combat cancer and life-threatening viral infections, and for potential use in organ transplantation. The Hemopurifier has demonstrated the removal of life-threatening viruses in human studies and harmful exosomes from biological fluids in preclinical studies, utilizing its proprietary lectin-based technology. The Hemopurifier holds FDA Breakthrough Device designation for advanced or metastatic cancer patients unresponsive to standard care and for cancer types where exosomes contribute to disease development or severity. It also has Breakthrough Device designation and an open Investigational Device Exemption (IDE) application for treating life-threatening viruses without approved therapies.
"The activation of the investigative site at the Royal Adelaide Hospital marks a significant milestone for Aethlon, allowing the site to screen and enroll patients in this important clinical trial," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We look forward to working closely with Prof. Brown and his staff, and with our Contract Research Organizations (CROs), NAMSA and ReSQ Clinical Research, to begin enrollment and data collection. Going forward, we plan to activate a second site in Australia and also expect to receive an Ethics Committee approval for a clinical site in India."
