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March 4, 2013
06:06 EDTCTICCell Therapeutics announces positive results from OPAL study of tosedostat
Cell Therapeutics and Chroma Therapeutics announced that Lancet Oncology has published results from the OPAL Phase 2 study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia. Tosedostat is an oral aminopeptidase inhibitor which has been shown to deprive tumor cells of the amino acid building blocks they need to make proteins necessary for tumor cell survival. The trial showed that once-daily oral tosedostat resulted in a disease control rate of 51%. Subset analyses suggested the greatest benefit occurred in the difficult-to-treat patients with prior myelodysplastic syndrome or those that had received prior hypomethylating therapy. Adverse events were mild, predictable and manageable.
News For CTIC From The Last 14 Days
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October 2, 2015
17:19 EDTCTICBiotechnology Value Fund reports 5.2% passive stake in CTI BioPharma
October 1, 2015
05:31 EDTCTICCTI BioPharma, Fred Hutchinson Cancer Research Center report research fellowship
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September 24, 2015
16:35 EDTCTICCTI BioPharma announces $15.7M registered direct offering
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September 23, 2015
09:08 EDTCTICCTI BioPharma to submmit NDA for pacrtinib in Q4
CTI BioPharma announced its plan to submit a new drug application to the FDA following a productive pre-NDA meeting for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The company expects to submit the NDA in Q4 and to request accelerated approval for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter. Submission of an NDA after a single Phase 3 trial under accelerated approval, instead of waiting to complete two Phase 3 trials, could potentially reduce time to market by up to 14 months.

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