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news.Cerus announced submission of a clinical protocol to the U.S. Food and Drug Administration (FDA) to make the INTERCEPT Blood System for plasma available under a Compassionate Use Investigational Device Exemption (IDE) for treatment of convalescent plasma collected from Ebola disease survivors for passive immune therapy.
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A Compassionate Use IDE allows access to an unapproved product for U.S. patients with serious or life-threatening conditions for whom the treating physician believes the treatment may provide a benefit.
Transfusion of blood or plasma from recovered Ebola virus patients has demonstrated benefit in patients with acute Ebola virus infections. However, recovered patients may carry undetected pathogens due to prior exposure.
"Convalescent plasma is one of the few therapies available for patients with Ebola virus disease. We believe that INTERCEPT pathogen inactivation can provide a critical risk mitigation strategy to the treatment process by inactivating potentially harmful organisms like malaria or HIV, without impacting the anti-Ebola antibodies that the patient needs," said Laurence Corash, Cerus’ chief medical officer.
"We are prepared to request an expedited review of our Compassionate Use IDE protocol should a new patient require treatment during the FDA review of the IDE."
Plasma collected from individuals who have recovered from Ebola virus disease contains antibodies against the virus — antibodies that can help fight Ebola infection in the recipient of the transfused plasma. Blood from recovered patients was first used as an Ebola treatment in 1995, during the Ebola outbreak in Kikwit, Democratic Republic of Congo.
The World Health Organization recently identified convalescent plasma as a potentially promising experimental approach to Ebola virus disease therapy, issuing interim guidance suggesting how the plasma should be sourced and supplied. Passive immune therapy using convalescent plasma has become the standard of care for treatment of other hemorrhagic viral infections.
The INTERCEPT plasma system license application is under FDA review, with an approval decision expected in 2015. The INTERCEPT system has been approved for use in Europe for eight years and is used in over 100 blood centers outside the US.