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Cell Therapeutics Inc Announces Agreement With FDA On Special Protocol Assessment For Planned Pivotal Phase 3 Trial Of Pacritinib In Myelofibrosis


Monday, 7 Oct 2013 01:30am EDT 

Cell Therapeutics Inc announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the planned pivotal Phase 3 clinical trial, known as the PERSIST-2 trial, evaluating pacritinib compared to best available therapy, including approved JAK2 inhibitors such as ruxolitinib, in patients with myelofibrosis whose platelet counts are <100,000/uL. The SPA is a written agreement between CTI and the FDA regarding the design, endpoints and planned statistical analysis approach of the trial to be used in support of a potential New Drug Application (NDA) submission. The PERSIST-2 trial is the second of two planned Phase 3 clinical trials in patients with myelofibrosis. CTI expects to initiate the PERSIST-2 clinical trial in the fourth quarter of 2013. Based on pacritinib's efficacy and tolerability profile demonstrated to date, CTI is pursuing a broad approach to advancing this therapy for myelofibrosis patients by conducting two Phase 3 clinical trials: one in a broad set of patients without limitations on blood platelet counts, the PERSIST-1 trial, and the other in patients with low platelet counts, the PERSIST-2 trial, as described above, which is expected to begin in the fourth quarter of 2013. 

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26 Dec 2014