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Cell Therapeutics Reaches Agreement with FDA on SPA for Planned Pivotal Phase 3 Trial of Pacritinib in Myelofibrosis


Cell Therapeutics (NASDAQ: CTIC) today announced that the company 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.

"The FDA worked closely with us to achieve SPA agreement during first cycle review of the PERSIST-2 trial protocol for pacritinib," stated James A. Bianco, M.D., CTI's President and CEO.  "As a result of the SPA, which established agreement on trial design to support regulatory approval, we expect that we will

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