bluebird bio initiates treatment in Northstar-2, the Phase III study of LentiGlobin in patients with transfusion-dependent beta-thalassemia .
Treatment has begun of the first patient in Northstar-2, the Phase III study of the LentiGlobin drug product from bluebird bio in patients with transfusion-dependent beta-thalassemia (TDT) and non-?0/?0 genotypes. This study will use LentiGlobin drug product manufactured with the addition of transduction enhancers intended to increase the drug product vector copy number and percent of cells transduced. The study�s primary endpoint is the proportion of treated subjects who meet the definition of "transfusion independence," defined as total hemoglobin levels of at least 9g/dL without any RBC transfusions for a continuous period of at least 12 months at any time during the study.
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