Aethlon Medical is making traction in the move to extend the Hemopurifier’s reach in the oncology market. On Monday, FDA granted the San Diego-based company’s Hemopurifier an IDE to initiate an early feasibility study of the Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (KeyTruda).

Aethlon’s early feasibility study will enroll 10 to 12 patients at a single center. The primary endpoint for the study 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. The company said 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" Timothy Rodell, MD, Aethlon's CEO, said in a release. "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 FDA and clearly demonstrates the value of the Breakthrough program."

Aethlon’s Hemopurifier has been designated as a breakthrough device for the treatment of glycosylated life-threatening viruses including Ebola and other hemorrhagic fever viruses.

In November of 2018, the device was given a second breakthrough device designation by FDA for the treatment of cancer specifically advanced and metastatic cancers that are unresponsive to or intolerant of a standard of care therapy.