US FDA Authorizes Blood Purification Device to Treat Acute Respiratory Failure in COVID-19 Patients

(Lakewood, CO, USA) and Marker Therapeutics AG (Zug, Switzerland) have obtained the US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) for the use of their blood purification device to treat acute respiratory failure in COVID-19 patients. Terumo BCT’s Spectra Optia Apheresis System combined with Marker Therapeutics’ D2000 Adsorption Cartridge has been authorized by the FDA for emergency use to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) who have been admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure to reduce pro-inflammatory cytokine levels.

Terumo BCT, which focuses on blood component, therapeutic apheresis and cellular technologies, has entered into a collaboration with Marker Therapeutics, which has a patented and CE marked plasma cartridge for the removal of a range of inflammatory cytokines, metabolic waste, toxins and poisons from plasma in the mediation of acute life-threatening inflammatory conditions, including cytokine storms and Severe Inflammation Response Syndrome. Terumo BCT’s Spectra Optia Apheresis System and Marker Therapeutics’ D2000 Adsorption Cartridge work together by reducing the number of cytokines and other inflammatory mediators, i.e., small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient. The proteins that are removed are typically elevated during infections and can be associated with a “cytokine storm” that occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.

“We thank the Food and Drug Administration for their expedited review, which provides another treatment option for patients in the ICU to help reduce the severity of the disease,” said Antoinette Gawin, CEO and President of Terumo BCT, and David Cohen, Chairman of Marker Therapeutics.

“The pace of this collaboration between the companies is incredible. We are leaving no stone unturned in exploring existing and new ways for our products to mitigate the impact of COVID-19,” said Gawin.

“By combining our plasma adsorption cartridge with Terumo BCT’s technology, this partnership offers the potential to develop a unique global solution for treatment of acute respiratory failure in COVID-19,” added Cohen.

Related Links:
Terumo BCT, Inc.
Marker Therapeutics AG