On November 11, 2024 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported enrollment of the first patient in its Australian safety, feasibility and dose-finding clinical trial of the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda (pembrolizumab) or Opdivo (nivolumab) (AEMD-2022-06 Hemopurifier Study) (Press release, Aethlon Medical, NOV 11, 2024, View Source [SID1234648087]). The patient was enrolled on October 29, 2024, by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia.
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The first patient completed screening activities confirming their eligibility on November 8, 2024, and has now entered a two-month run-in period, receiving anti-PD-1 therapy. During this time, concentrations of Extracellular vesicles (EVs) and anti-tumor T cell activity will be measured. If imaging after this two-month run-in period reveals no improvement in the patient’s tumor, they will be treated with the Hemopurifier, followed by monitoring to identify decreases in EV concentrations and improvements in T cell anti-tumor activity.
"Enrollment of the first patient represents the achievement of a critical milestone for Aethlon Medical in the clinical development of the Hemopurifier in Oncology," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We are thrilled with the pre-screening activity being done to identify patients at Royal Adelaide, as well as the second site, Pindara Private Hospital in the Gold Coast. We are grateful to the patient for consenting to be part of this study. This trial is our initial step in determining if the Hemopurifier treatment can improve upon the 30-40% response rates to anti-PD-1 therapies such as Opdivo and Keytruda."
Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. EVs produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of exosomes from the plasma of cancer patient samples.
The primary endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial is the incidence of adverse events and clinically significant changes in safety lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda or Opdivo monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.