On December 16, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, reported that the first patient has been treated in the Company’s first-in-human Early Feasibility Study (EFS) evaluating the HEMOPURIFIER in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (Press release, Aethlon Medical, DEC 16, 2020, View Source [SID1234572958]). The study is enrolling patients at UPMC Hillman Cancer Center in Pittsburgh, PA. (Hemopurifier Plus Pembrolizumab in Head and Neck Cancer – Full Text View – ClinicalTrials.gov).

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The EFS, which is the device equivalent of a Phase 1 clinical trial for a drug or biologic, is a single center, open label trial in 10 to 12 subjects. The study is evaluating the HEMOPURIFIER for reducing cancer-associated exosomes prior to the administration of standard-of-care pembrolizumab (KEYTRUDA), which is a first-line therapy for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The primary endpoint for the study is safety of the HEMOPURIFIER in a clinical setting. Secondary endpoints include efficacy based on response rates, progression-free and overall survival, and changes in exosome concentration after HEMOPURIFIER treatment.

In cancer, exosomes have been shown to participate in the development and advancement of disease. Exosomes derived from tumor cells may promote immune suppression and seed the spread of metastasis. These tumor derived exosomes may also inhibit the activity of immuno-oncology drugs such as KEYTRUDA. Tumor derived exosomes are not currently addressed with any approved therapy.

Dan Zandberg, M.D., Medical Oncologist and Hematologist at UPMC Hillman Cancer Center, Associate Professor of Medicine at the University of Pittsburgh School of Medicine and Principal Investigator of the study, stated, "We are excited to have treated the first head and neck cancer patient with the HEMOPURIFIER. While KEYTRUDA can markedly improve outcome in some head and neck cancer patients, the majority of patients still do not respond. If clearance of exosomes with the HEMOPURIFIER prior to treatment with KEYTRUDA can increase the number of patients who are able to respond to KEYTRUDA, it could represent an important advance in the treatment of this disease. This trial represents the first step in this evaluation."

Charles J. Fisher, Jr., M.D., Chief Executive Officer of Aethlon, stated, "We are delighted to be working with Dr. Zandberg and his colleagues at the University of Pittsburgh and UPMC Hillman to treat the first head and neck cancer patient with the HEMOPURIFIER. By reducing the presence of immune suppressive exosomes from the circulatory system of head and neck cancer patients prior to treatment with KEYTRUDA, we believe the HEMOPURIFIER could have the potential to improve patient outcomes in this disease. The initiation of this first-in-human study addressing cancer-associated exosomes is a significant step towards evaluating the HEMOPURIFIER for potentially improving the efficacy of KEYTRUDA in head and neck cancer."