SAN DIEGO: Aethlon Medical, Inc. announced today that the Institutional Review Board (IRB) of the University of California, Irvine (UCI) has approved a multi-indication clinical study entitled, "Plasma Exosome Concentration in Cancer Patients Undergoing Treatment."
Aethlon previously disclosed that it had entered into investigator-initiated clinical trial agreement with UCI, which was pending IRB approval. Under the approved clinical protocol, the study will seek to enroll five individuals in each of nine defined tumor types for a total study population of up to 45 subjects. The tumor types include the following forms of cancer; Breast adenocarcinoma, Colorectal, Gastric & Gastroesophageal, Pancreatic, Cholangiocarcinoma, Lung (NSCLC), Head & Neck (SCC), Melanoma and Ovarian adenocarcinoma. The principal investigator of the study is Edward Nelson, M.D.
The study endpoints include establishing baseline exosome levels and monitoring changes in circulating exosome concentration associated with tumor treatment and the association of longitudinal changes in circulating exosome concentrations with response to treatment. Recruitment of participants in the study will be through the use of internal and outside referrals to the University of California, Irvine Medical Center (UCIMC).
The clinical study will also provide data to help direct future clinical investigations of the Aethlon Hemopurifier® as a therapeutic candidate to reduce the presence of circulating tumor-derived exosomes, which are known to suppress the immune system of cancer patients and contribute to the spread of metastasis. The Hemopurifier® is a first-in-class biofiltration device that targets the single-use removal of viruses and tumor-derived exosomes from the circulatory system.