Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases, today announced that, on September 9, 2024, the Medanta Institutional Ethics Committee (MIEC) granted full ethics approval for Aethlon’s safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer 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).
The approval is valid for one year, followed by annual reviews. This trial has previously been reviewed by the Institutional Review Board at Medanta. Additionally, the company previously received a No Objection Certificate (NOC) from DCGI (the Indian Regulatory Authority) for the proposed oncology trial. The trial will be conducted by Dr. Ashok K. Vaid and his staff at the Department of Medical Oncology and Hematology at Medanta Medicity Hospital in Gurugram, India. The Hemopurifier treatments will be performed by Dr. Puneet Sodhi from the Department of Nephrology, who has conducted more Hemopurifier treatments than anyone else in the world.
“The approval from the MIEC, coming closely on the heels of our two ethics committee approvals in Australia, to conduct this early feasibility study, is another important step in our plan to evaluate use of the Hemopurifier as a treatment option in multiple tumor types, where cancer associated exosomes may promote immune suppression and metastasis,” stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. “We are very pleased that the MIEC accepted our study protocol and look forward to working, again, with Medanta Hospital with the expectation of recruiting patients in the fourth calendar quarter of this year. We believe that the planned safety, feasibility and dose finding trial, taking place in both India and Australia, in solid tumors in patients failing treatment with anti-PD-1 antibodies, will help inform future oncology efficacy trails.”
At present, only approximately 30% of cancer patients who receive pembrolizumab or nivolumab treatment for solid tumors will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in resistance to anti-PD-1 therapies as well as the spread of cancers. 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 EVs in cancer patient plasma samples.
The primary endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial is safety. The trial will monitor any adverse events and clinically significant changes in 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 PD-1 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.