Pacritinib: Phase III started

Cell Therapeutics began the open-label, international Phase III PERSIST-2 trial to compare 200 mg pacritinib twice daily and 400 mg pacritinib once daily vs. best available therapy, including approved JAK-2 inhibitors, in up to 300 patients with myelofibrosis whose platelet counts are <=100,000/µL. The company has an SPA from FDA for the trial. Last January, the company began the open-label, international Phase III PERSIST-1 trial comparing 400 mg oral pacritinib once daily vs. best available therapy, excluding JAK inhibitors, in 270 patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis (see BioCentury, Jan. 14, 2013). Pacritinib has Orphan Drug designation in the U.S. for myeloproliferative disorders and in the EU for myelofibrosis. ...