Aethlon Medical, Inc. (announced today that the FDA has approved its Investigational Device Exemption (IDE) application to initiate an Early Feasibility Study (EFS) of the Company’s proprietary Hemopurifier® in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda).
An EFS for a medical device is similar to a phase 1 study for a drug or biologic and as such this trial will enroll a small number of patients with advanced head and neck cancer who cannot be treated with surgery or radiation. In this patient population, pembrolizumab was recently approved for initial first line treatment. Non-clinical studies conducted by Aethlon Medical’s collaborators and other investigators have suggested that a primary mechanism of resistance to pembrolizumab and other immuno-oncology drugs is the secretion by tumor cells of exosomes, which are small, sub-cellular particles that have previously been demonstrated to be cleared by the Hemopurifier. Based on this observation, in November 2018 the FDA granted the Hemopurifier® a Breakthrough Designation “…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease.”
The primary endpoint for the EFS, which will enroll 10-12 subjects at a single center, will be safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. The IDE approval is subject to FDA approval of Informed Consent documents from the trial site. More details on the trial will be disclosed in the future.
“This IDE approval is a critical first step in our plans to develop the Hemopurifier for applications in oncology” stated Timothy Rodell, M.D., Aethlon’s CEO. “We believe that the clearance of immunosuppressive tumor-derived exosomes has the potential to improve response rates to these already game-changing immuno-oncology agents. Our Breakthrough Designation has allowed us to move very quickly with rapid, frequent and helpful communication with the FDA and clearly demonstrates the value of the Breakthrough program.”