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CTI BioPharma Enrolls First Patient In COVID-19 PRE-VENT Phase 3 Trial Of Pacritinib

CTI BioPharma Corp. (CTIC) said Monday it has enrolled the first patient in the Phase 3 PRE-VENT trial (NCT04404361) of pacritinib in hospitalized patients with severe COVID-19. The company expects to report topline data from the trial by the end of 2020.

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

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1 and CSF1R.

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 BioPharma said an interim analysis will be conducted for futility after 154 patients are enrolled.

Safety will be assessed through 30 days of follow-up after the last dose of study treatment and assessed by the cumulative incidence, severity and seriousness of treatment-emergent AEs, drug discontinuations, laboratory values, and clinical assessments.

"Initiation of patient enrollment in the PRE-VENT Phase 3 trial is an important step for CTI as we work towards providing a new therapeutic option for patients with severe COVID-19. As a multi-kinase inhibitor, pactrinib has the potential to reduce the effects of the cytokine storm that occurs with the novel coronavirus infection, an inflammatory response that frequently leads to respiratory failure and need for mechanical ventilation," said Adam Craig, President and Chief Executive Officer of CTI BioPharma.

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