CTI BioPharma Provides Program Update Following Regulatory Feedback from the U.S. FDA on Pacritinib Development
CTI BioPharma Corp. (CTIC)
Last cti biopharma corp. earnings: 11/1 08:00 am
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Source: PR Newswire
SEATTLE, Dec. 18, 2018 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) announced today that it has received input from the U.S. Food and Drug Administration (FDA) at a recent Type C meeting 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. The planned Phase 3 study is designed to evaluate the effects of pacritinib as compared to physician's choice of treatment. The primary efficacy endpoint will be the proportion of patients achieving a greater than or equal to 35% spleen volume reduction (SVR) between baseline and Week 24. Secondary efficacy endpoints of the study include total symptom score re
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