Aethlon Medical, Inc. (Nasdaq: AEMD), closed down -11.16% to $2.07 at the last close, after a clinical medical product and technology organization concentrating on unmet needs of infectious diseases, oncology and inflammation, confirmed that the first patient had been treated in the Company’s first-in-human Early Feasibility Study (EFS) applying the HEMOPURIFIER to patients with recurrent and metastatic squamous cell carcinoma of the neck. The study is enrolling patients at UPMC Hillman Cancer Center in Pittsburgh, PA.
EFS is an open-label, and a single-center trial is equivalent to Phase 1 clinical trials for drugs or biologics. The study evaluates the HEMOPURIFIER for reducing cancer-associated exosomes before administering standard-of-care pembrolizumab, which is first-line therapy for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The primary endpoint is the safety of the HEMOPURIFIER in a clinical setting. A secondary endpoint includes efficacy based on response rates, progression-free and overall survival, and exosome concentration changes following HEMOPURIFIER treatment.
Exosomes have been implicated in the development and progression of cancer. Exosomes derived from cancer cells may promote immune suppression and facilitate the spread of metastasis. Cancer derived exosomes could also inhibit the activity of immuno-oncology drugs such as KEYTRUDA. There is no approved therapy to address tumor-derived exosomes.