04.15.15
San Diego, Calif.-based Aethlon Medical Inc., which makes targeted therapeutic device to address infectious diseases and cancer, has begun an investigator-initiated clinical trial agreement with the University of California, Irvine in California. Under the agreement, a clinical study protocol entitled “Plasma Exosome Concentration in Cancer Patients Undergoing Treatment” 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 breast adenocarcinoma, colorectal, gastric and gastroesophageal, pancreatic, cholangiocarcinoma, lung, head and neck, 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.
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. According to Aethlon Medical, it is a first-in-class bio-filtration device that targets the single-use removal of viruses and tumor-derived exosomes from the circulatory system.
Recruitment of participants in the study will be through the use of internal and outside referrals to the University of California, Irvine Medical Center. Review and approval of this human protocol will be conducted by the UCI Institutional Review Board Human Subjects Review Committee.
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.
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. According to Aethlon Medical, it is a first-in-class bio-filtration device that targets the single-use removal of viruses and tumor-derived exosomes from the circulatory system.
Recruitment of participants in the study will be through the use of internal and outside referrals to the University of California, Irvine Medical Center. Review and approval of this human protocol will be conducted by the UCI Institutional Review Board Human Subjects Review Committee.