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Press Release

First COVID-19 Patient Receives Therapy Targeting Cytokine Storm Under FDA EUA

System Combines Terumo BCT and Marker Therapeutics AG devices to help severely ill COVID-19 patients
  • ​First severely ill COVID-19 patient receives treatment using selective removal of inflammatory cytokines from their plasma
  • Selective removal of inflammatory cytokines may reduce the cytokine storm impact in COVID-19 ICU patients with imminent respiratory distress
  • The patient who received treatments is stable

LAKEWOOD, COLO., U.S.A. – The first patient was treated by removing an overload of inflammatory cytokines from their plasma to treat a severe case of COVID-19. Under the approved Food and Drug Administration (FDA)’s Emergency Use Authorization (EUA),1 the treatment is intended to reduce the impact of cytokine storm using Terumo BCT’s Spectra Optia® Apheresis System combined with Marker Therapeutics AG’s D2000 Adsorption Cartridge in patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. The cytokine storm that occurs in some COVID-19 patients can lead to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.​

The patient is in the intensive care unit (ICU) at a U.S. hospital with a confirmed case of COVID-19 and in respiratory distress and on mechanical ventilation.

Colorado-based Terumo BCT is a medical device company focused on blood and cell innovations. Swiss-based Marker Therapeutics AG is a diagnostics and therapeutics company. They formed this collaboration to combine their existing technologies to provide an innovative approach to help treat severe respiratory symptoms caused by COVID-19.

"Treating the first patient is an important milestone to gather data that will better help doctors treat COVID-19 cases," said Antoinette Gawin, President and Chief Executive Officer, Terumo BCT. "It is heartening to see treatment options developed that have the potential to help now."

David Cohen, Chairman, Marker Therapeutics AG, said: "We look forward to demonstrating the potential benefit of this treatment to severely ill patients in the ICU in the upcoming weeks and providing the ICU doctors at participating sites with an immediate therapy to help those COVID‑19 patients at the highest risk."

How Does the Therapy Work?
The combination of Spectra Optia and the D2000 Adsorption Cartridge is designed to reduce inflammatory cytokines in the patient's plasma that can lead to a cytokine storm. Spectra Optia separates plasma from the patient's blood, and the plasma is then passed through the D2000 Adsorption Cartridge to reduce the levels of cytokines. The treated plasma is recombined with the rest of the blood and then returned to the patient.

Based on the attending physician's discretion, the course of each treatment is expected to take between two and four hours per day performed over two to three days. According to the FDA's approval of the EUA, up to 2,000 patients' data from up to 15 clinical sites in the U.S. can be collected for a study, analyzed and published.

1About Emergency Use Authorization Status
The Spectra Optia Apheresis System with the D2000 Adsorption Cartridge has been neither cleared nor approved for the indication to treat patients with COVID-19 infection; it has been authorized by the FDA under EUA 200148 for emergency use to treat patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure to reduce pro-inflammatory cytokine levels, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

The Spectra Optia Apheresis System with the D2000 Adsorption Cartridge is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Spectra Optia Apheresis System with the D2000 Adsorption Cartridge under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Currently, there are no FDA-approved, licensed, or cleared device treatments for COVID-19. 

About Terumo BCT
Terumo BCT is a global leader in blood component, therapeutic apheresis and cell therapy technologies. We believe in the potential of blood and cells to do even more for patients than they do today. This belief inspires our innovation and strengthens our collaboration with customers. TERUMOBCT.com

About Marker
Marker Therapeutics AG is a subsidiary of Marker AG, a Swiss-based diagnostics and therapeutics company. Marker Therapeutics 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. Marker Diagnostics AG also has a patented and CE marked salivary clinical concussion diagnostic test in the rapidly emerging area of sncRNA-based diagnostics using qPCR analytical technology. markerhealth.com

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