The US Food and Drug Administration (FDA) has approved a supplement to Aethlon Medical’s existing investigational device exemption (IDE) for its Hemopurifier device in viral disease.
The approvals enable the testing of the Hemopurifier in patients with SARS-CoV-2/Covid-19 in a new feasibility study.
Hemopurifier is a clinical-stage device designed to fight cancer and life-threatening viral infections. It is an FDA designated breakthrough device to treat life-threatening viruses that are not addressed with approved therapies.
Aethlon Medical said the feasibility study is the device equivalent of a phase 1 trial and will enrol up to 40 subjects at approximately 20 centres in the US with established laboratory diagnosis of Covid-19.
Other criteria for subjects include being admitted to an intensive care unit and having acute lung injury and / or severe or life-threatening disease.
Aethlon Medical CEO Timothy Rodell said: “We believe that the Hemopurifier may have the potential to help severely affected patients with Covid-19. We believe that clearing circulating virus in these patients, in combination with other supportive measures, could improve outcomes in this deadly disease.”
The Hemopurifier device has earlier been tested in patients with hepatitis C virus infection and in a patient with Ebola virus infection. The device has not yet received FDA approval for any indication.
A laboratory version of the Hemopurifier has been demonstrated to clear several other viruses in Vitor, including a model version of the Middle Eastern Respiratory Syndrome (MERS) virus.
MERS virus is a coronavirus from the same family as the SARS-CoV-2 virus that causes Covid-19.