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Preliminary late-stage data on bluebird's LentiGlobin underwhelms investors; shares off 11%

Jun. 23, 2017 9:44 AM ETbluebird bio, Inc. (BLUE) StockBy: Douglas W. House, SA News Editor1 Comment
  • Gene therapy developer bluebird bio (NASDAQ:BLUE -11.1%) slumps out the blocks as investors head for exits after the company released preliminary data from the Phase 3 Northstar-2 study assessing its LentiGlobin drug product in patients with transfusion-dependent beta thalassemia and non-β0genotypes. The results will be presented at the European Hematology Association Annual Meeting in Madrid.
  • The primary endpoint of the 15-subject trial is the proportion of patients who achieve transfusion independence as defined by total hemoglobin levels of at least 9 g/dL without any red blood cell transfusions for a continuous period of at least 12 months at any time during the study.
  • As of June 2, LentiGlobin had been manufactured for six patients using an improved process aimed at increasing vector copy number (VCN) and the percentage of cells successfully transduced.
  • Data are presented on the first three patients, but the hemoglobin value is only presented for patient #1 (13.3) at month 6. Follow-up of the other two patients was not sufficient to be clinically relevant.
  • According to ClinicalTrials.gov, the primary completion date of the study is January 2020.
  • Previously: Dosing underway in bluebird's late-stage study of LentiGlobin in beta thalassemia (Dec. 14, 2016)

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