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.
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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.”
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By GlobalDataThe 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.
