Aethlon Medical has received independent internal review board (IRB) approval to start human clinical studies of Hemopurifier therapy at DaVita MedCenter Dialysis in Houston, Texas, US.
Hemopurifier is a first-in-class therapeutic device that targets the rapid elimination of circulating viruses and tumour-secreted exosomes that suppress the immune system of cancer patients.
The US Food and Drug Administration (FDA) had previously approved an investigational device exemption (IDE) that would allow for the start of Hemopurifier feasibility studies in the US.
As a result of the independent IRB approval, Aethlon is now permitted to begin the IDE approved trial.
Patients who meet the trial inclusion/exclusion criteria are expected to be enrolled in the coming weeks.
Upon receipt of IDE approval, the company started discussions with various clinical partner candidates.
In May, the company completed a definitive agreement with DaVita Clinical Research (DCR), a specialty contract research organisation (CRO) with experience in conducting more than 300 early phase clinical trials.
As a subsidiary of DaVita Healthcare Partners, DCR has access to one third of the total US end-stage renal disease (ESRD) patient population and maintains a network that exceeds 150 investigative physicians' practices at more than 250 clinical sites.
As part of the feasibility study protocol, the company will enrol ten ESRD patients who are infected with the Hepatitis C virus (HCV) to show the safety of Hemopurifier therapy in an infectious disease model.
Following completion of the feasibility study, the company intends to conduct pivotal efficacy studies required for market clearance to treat HCV and other chronic viral indications.
Previous clinical trials of Hemopurifier therapy have been carried out in HIV and HCV-infected persons at India-based hospitals including Apollo Hospital, Fortis Hospital, Sigma New Life Hospital and the Medanta Medicity Institute.
Feasibility study of the company will also contribute safety data to advance the Hemopurifier as a broad-spectrum countermeasure against high-risk bioterror and pandemic threats.