Aethlon Medical, Inc. has announced that the Medanta Institutional Ethics Committee (MIEC) granted full ethics approval on September 9, 2024, for its clinical trial evaluating the Hemopurifier in cancer patients with solid tumors. The trial will focus on patients who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as with pembrolizumab (Keytruda) or nivolumab (Opdivo).
The AEMD-2022-06 Hemopurifier Study is designed as a safety, feasibility, and dose-finding trial. It has already been reviewed by the Institutional Review Board at Medanta and has received a No Objection Certificate (NOC) from the Drugs Controller General of India (DCGI).
Trial Details and Objectives
The clinical trial will be conducted at Medanta Medicity Hospital in Gurugram, India, by Dr. Ashok K. Vaid and his team from the Department of Medical Oncology and Hematology. Dr. Puneet Sodhi from the Department of Nephrology, who has extensive experience with Hemopurifier treatments, will administer the Hemopurifier.
"The approval from the MIEC...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.
The trial's primary endpoint is safety, with secondary objectives including assessing the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles (EVs) and evaluating whether these changes improve the body's ability to attack tumor cells. The study will involve approximately nine to 18 patients, monitoring adverse events and changes in lab tests after a two-month run-in period with PD-1 antibody monotherapy. Patients will then receive one, two, or three Hemopurifier treatments over a week.
Hemopurifier's Mechanism and Rationale
Currently, only about 30% of cancer patients with solid tumors experience lasting clinical responses to pembrolizumab or nivolumab. Tumor-produced extracellular vesicles (EVs) have been implicated in resistance to anti-PD-1 therapies and the spread of cancers. The Hemopurifier is designed to bind and remove these EVs from the bloodstream, potentially improving therapeutic response rates to anti-PD-1 antibodies. Preclinical studies have demonstrated the Hemopurifier's ability to reduce the number of EVs in cancer patient plasma samples.
Implications for Immunotherapy
This trial is part of a broader effort to enhance immunotherapy outcomes in cancer treatment. Other companies, such as Immuneering Corporation and Iovance Biotherapeutics, are also advancing immunotherapy treatments with promising results. Immuneering's IMM-1-104, combined with chemotherapy, has shown encouraging initial response data in pancreatic cancer, while Iovance's lifileucel has received FDA approval as the first TIL therapy for solid tumors.
Aethlon's Hemopurifier: A Breakthrough Device
Aethlon Medical is focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. The Hemopurifier has received FDA Breakthrough Device designation for advanced or metastatic cancer patients unresponsive to standard care and for cancer types where exosomes contribute to disease development. It also holds a Breakthrough Device designation and an open Investigational Device Exemption (IDE) application for treating life-threatening viruses.
