US-based therapeutic devices developer Aethlon Medical has entered an investigator-initiated cancer clinical trial agreement with the University of California (UCI), Irvine, US.
As part of the deal, a clinical study protocol entitled ‘Plasma Exosome Concentration in Cancer Patients Undergoing Treatment’ will enroll 45 patients, five individuals in each of nine defined tumour types.
The tumour types include breast adenocarcinoma, colorectal cancer, gastric and gastroesophageal cancer, pancreatic cancer, cholangiocarcinoma, non-small cell lung cancer (NSCLC), head and neck cancer (SCC), melanoma and ovarian adenocarcinoma.
University of California Division of Hematology and Oncology chief Edward Nelson will be principal investigator of the trial.
The company said endpoints of the trial include establishing baseline exosome levels and monitoring changes in circulating exosome concentration associated with tumour treatment, and the association of longitudinal changes in circulating exosome concentrations with response to treatment.
The trial will also provide data to help direct future clinical investigations of the Aethlon Hemopurifier as a therapeutic candidate to reduce the presence of circulating tumour-derived exosomes.
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According to the company, the Hemopurifier is a first-in-class bio-filtration device that targets the single-use removal of viruses and tumour-derived exosomes from the circulatory system.
Tumour-derived exosomes are known to suppress the immune system of cancer patients and contribute to the spread of metastasis.
In the trial, patient enrolment will be done using internal and outside referrals to the UCI Medical Center (UCIMC).
The UCI Institutional Review Board (IRB) Human Subjects Review Committee will be responsible for conducting review and approval of this human protocol.
In February, the company announced the first patient enrolled in its clinical feasibility trial completed the full Hemopurifier treatment protocol, without any device-related adverse events.
The feasibility trial is being conducted at DaVita Med Center Dialysis under an investigational device exemption (IDE) approved by US Food and Drug Administration (FDA).
During the trial, ten chronic dialysis patients infected with hepatitis C virus (HCV) will receive a six treatment protocol of Hemopurifier therapy.
Safety data from the trial will help in advancing Hemopurifier as a candidate therapy to address chronic conditions such as HIV and HCV, as well as acute bioterror and pandemic threats that are not addressed with proven drug or vaccine therapies.
Image: Aethlon Hemopurifier. Photo: courtesy of Aethlon Medical Inc.