SEATTLE, July 18, 2018 /PRNewswire/ — CTI BioPharma Corp. (NASDAQ:CTIC) today announced that it recently conducted a Type B meeting with the U.S. Food and Drug Administration (FDA) for its lead product candidate pacritinib. The purpose of the meeting was to discuss the regulatory pathway for pacritinib. Based on FDA feedback, the Company plans to conduct a randomized …
Tag Archives: cti biopharma
July, 2018
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10 July
CTI BioPharma’s Pixurvi Fails to Meet Primary Endpoint in Phase 3 Non-Hodgkin Lymphoma Trial
PARIS–(BUSINESS WIRE)–CTI BioPharma Corp. and Servier today announced that the pivotal Phase III study (PIX306) evaluating PIXUVRI® (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of improvement of progression-free survival (PFS). “We are …
January, 2017
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6 January
FDA Removes Full Clinical Hold On CTI BioPharma’s Pacritinib for Myelofibrosis
SEATTLE, Jan. 5, 2017 /PRNewswire/ — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced that the full clinical hold (February 2016) implemented by the U.S. Food and Drug Administration (FDA) on all clinical trials conducted under the Investigational New Drug (IND) application for pacritinib has now been removed. …
August, 2016
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29 August
CTI BioPharma’s Late-Stage Study of Lead Candidate Shows Mixed Results in Advanced Myelofibrosis
SEATTLE, Aug. 29, 2016 /PRNewswire/ — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced top-line results from PERSIST-2, a randomized, controlled Phase 3 clinical trial comparing pacritinib, an investigational oral multikinase inhibitor, with physician-specified best available therapy (BAT), including ruxolitinib, for the treatment of patients with myelofibrosis …
February, 2016
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10 February
CTI Biopharma’s Myelofibrosis Study Placed on Full Clinical Hold, Following Patient Deaths
SEATTLE, Feb. 9, 2016 /PRNewswire/ — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today provided an update regarding the clinical studies being conducted under the Company’s Investigational New Drug (“IND”) application for pacritinib. Following the issuance of the Company’s February 8, 2016, press release describing the partial clinical …
March, 2015
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9 March
CTI BioPharma and Baxter’s Myelofibrosis Drug Meets Primary Endpoint in Late-Stage Trial
Baxter International and CTI BioPharma Corp. announced that its experimental blood cancer drug met its primary endpoint in a late-stage study. The companies announced top-line results for the primary endpoint from PERSIST-1, a Phase III registration clinical trial evaluating pacritinib, an oral JAK2/FLT3 multikinase inhibitor, for the treatment of patients …
February, 2015
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3 February
Committee Recommends Continuation of CTI BioPharma’s Ovarian Cancer Study
Today, CTI Biopharma Corp. announced that an independent committee has recommended that the company continue its ovarian cancer study. The company said that the Gynecologic Oncology Group, now part of NRG Oncology, informed CTI that an independent Data Monitoring Committee (DMC) recommended continuation of the Phase III GOG-0212 clinical study, …