CTI BioPharma announced the completion of full enrollment of 150 patients in the PAC203 Phase 2 study of pacritinib. The company expects to report the determination of the optimal dose of pacritinib in mid-2019 following a meeting with the U.S. Food and Drug Administration (FDA). Topline efficacy and safety data are expected in the third quarter of 2019, with the new Phase 3 study targeted to commence enrollment in the third quarter of 2019.
As previously announced, the company has received input from the FDA on key elements of the design of a new randomized Phase 3 study of pacritinib in adult patients with myelofibrosis (primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis) and who have severe thrombocytopenia (as defined by patients with platelet counts of less than 50,000 per microliter), an indication that has been recognized by the medical community as an important unmet medical need. A planned interim safety review by an Independent Data Monitoring Committee (IDMC) is scheduled to occur in the first quarter of 2019.
The PAC203 study is evaluating the safety and efficacy of three dosing schedules (100 mg once daily, 100 mg twice daily and 200 mg twice daily) over 24 weeks in patients with myelofibrosis previously treated with ruxolitinib.
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