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March 3, 2014
05:25 EDTCTICCell Therapeutics opens enrollment for PERSIST-2 Phase 3 trial of pacritinib
Cell Therapeutics announced the initiation of a Phase 3 clinical trial, known as PERSIST-2, which will evaluate pacritinib, a novel, investigational JAK2/FLT3 inhibitor, in patients with myelofibrosis whose platelet counts are less than or equal to 100,000 per microliter. The trial is expected to enroll up to 300 patients in North America, Europe, Australia and New Zealand within 12 to 14 months. In October 2013, CTI reached agreement with the FDA on a Special Protocol Assessment for the PERSIST-2 trial, which is a written agreement between CTI and the FDA regarding the planned design, endpoints and statistical analysis approach of the trial to be used in support of a potential New Drug Application, or NDA, submission. PERSIST-2 is the second of two planned Phase 3 trials in the pacritinib development program for myelofibrosis.
News For CTIC From The Last 14 Days
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November 24, 2015
05:32 EDTCTICCTI BioPharma announces advancement of tosedostat LI-1 trial
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November 23, 2015
09:18 EDTCTICOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Tyson Foods (TSN), up 2.4%... Mallinckrodt (MNK), up 7.4%. ALSO HIGHER: Novocure (NVCR), up 16.8% after announcing new Phase 3 data from Optune study... CTI BioPharma (CTIC), up 12.7% after the initiation of its rolling new drug application to the FDA for pacritinib... Peabody Energy (BTU), up 14.8% after announcing an asset sale... Sarepta Therapeutics (SRPT), up 5.2% following a positive mention in Barron's. DOWN AFTER EARNINGS: Trina Solar (TSL), down 5.6%. ALSO LOWER: Par Pacific (PARR), down 13.2% after pricing its 3.4M registered direct offering at $22.00... Lions Gate (LGF), down 2.9% after the "Hunger Games" finale opens below the series average.
05:39 EDTCTICCTI BioPharma initiates rolling submission of U.S. NDA for pacritinib
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