Medical device company Aethlon Medical Inc (Nasdaq:AEMD) stated on Monday that it has received the approval from the FDA for its Investigational Device Exemption (IDE) application to commence an Early Feasibility Study (EFS) of its proprietary Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda).

Under the EFS, the company will enroll 10-12 subjects with advanced head and neck cancer who cannot be treated with surgery or radiation at a single centre. In this patient population, pembrolizumab was approved for initial first line treatment. The primary endpoint will be safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates.

In conjunction, the non-clinical studies conducted by the company'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.

However in cancer, the Hemopurifier depletes the presence of circulating tumor-derived exosomes that promote immune suppression. These tumor derived exosomes also seed the spread of metastases and inhibit the benefit of leading cancer therapies.

The IDE approval is subject to FDA approval of Informed Consent documents from the trial site, concluded the company.