Aethlon Medical (NASDAQ:AEMD), has announced that the Medanta Institutional Ethics Committee (MIEC) has granted full ethics approval for a safety, feasibility, and dose finding study of its Hemopurifier in cancer patients with solid tumors not responding to anti-PD-1 antibodies.
The approval is valid for one year, followed by annual reviews. Aethlon has also received a No Objection Certificate from the Indian regulatory authority, DCGI, for the proposed oncology trial.
“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,” said Steven LaRosa, M.D., CMO of Aethlon Medical.
Dr. LaRosa added, “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.”
