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CTI Starts Pacritinib Trial In Hospitalized Patients With Severe COVID-19

CTI BioPharma Corp. (CTIC) announced Monday the initiation of PRE-VENT, a Phase 3 study evaluating pacritinib in hospitalized patients with severe COVID-19.

The study aims to determine whether Pacritinib, a JAK2/IRAK-1/CSF-1R inhibitor, can prevent progression to acute respiratory distress syndrome and mechanical ventilation.

PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care versus placebo plus standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer.

The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or die by Day 28.

CTI expects to commence enrollment of PRE-VENT in May at sites in the United States and in Europe with data expected by the end of 2020.

John Mascarenhas, Chief Investigator of the PRE-VENT Study, said, "Patients with severe COVID-19, particularly those with cancer, are at high risk for serious complications from the disease stemming from cytokine storm, an inflammatory response that causes white blood cells to not only fight the viral infection, but also damage tissue, primarily in the lungs. Because pacritinib inhibits JAK2, IRAK-1 and CSF1R, there is real potential for pacritinib to prevent patients from developing an inflammatory response to the coronavirus infection and subsequent pulmonary failure, therefore reducing the need for a ventilator."

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