CTI Biopharma Announces Initiation of Phase 3 PRE-VENT Study Evaluating Pacritinib in Hospitalized Patients with Severe COVID-19
CTI Biopharma Announces Initiation of Phase 3 PRE-VENT Study Evaluating Pacritinib in Hospitalized Patients with Severe COVID-19 - Study to Determine Whether Pacritinib Can Prevent Progression to Acute Respiratory Distress Syndrome and Mechanical Ventilation - |
[27-April-2020] |
SEATTLE, April 27, 2020 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced the initiation of PRE-VENT, a Phase 3 study evaluating pacritinib in hospitalized patients with severe COVID-19. PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care (SOC) 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. "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," said John Mascarenhas, M.D., Associate Professor, Medicine, Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York and Chief Investigator of the PRE-VENT Study. "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." "Given the unprecedented medical need to improve outcomes for patients with COVID-19, we have made a commitment to test pacritinib, a JAK2/IRAK-1/CSF-1R inhibitor, in hospitalized patients with severe COVID-19, with the goal of preventing progression to acute respiratory distress syndrome and mechanical ventilation," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "Emerging evidence suggests that the attenuation of the cytokine storm associated with COVID-19 could be a potential treatment approach for this devastating disease, and it is hypothesized that pacritinib may have a role in treating these patients. We would like to thank the FDA for their expedited review of the PRE-VENT protocol. Enrollment is expected to commence in the coming weeks. With ample supply of pacritinib available, we continue to recruit patients on the pivotal Phase 3 PACIFICA trial of pacrtitnib in myelofibrosis patients with severe thrombocytopenia." Cytokine storm is a pathological immune reaction that can be triggered by viral infection and can lead to serious complications, including acute respiratory distress syndrome (ARDS). Multiple inflammatory cytokines are upregulated in patients with severe COVID-19, including IL-1 and IL-6, and some patients have evidence of over-active macrophage activation. As a JAK2/IRAK-1 inhibitor, pacritinib may ameliorate the effects of cytokine storm via inhibition of IL-6 and IL-1 signaling. Furthermore, as a CSF-1R inhibitor, pacritinib may mitigate effects of macrophage activation syndrome. Of particular importance in this indication, pacritinib has not been associated with increased risk in infections in prior randomized studies, likely because it does not have inhibitory effects on JAK1. About PRE-VENT The primary endpoint is the effect of treatment on the proportion of patients who require invasive mechanical ventilation and/or extracorporeal membrane oxygenation, or die by Day 28. An interim analysis will be conducted for futility after 154 patients have been 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. About Pacritinib About CTI BioPharma Corp. Forward-Looking Statements "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner. CTI BioPharma Investor Contacts:
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