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News Breaks
February 12, 2013
16:13 EDTSGENSeattle Genetics reports Q4 EPS (9c), consensus (11c)
Reports Q4 revenue $63.9M, consensus $57.21M.
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December 18, 2014
09:03 EDTSGENSeattle Genetics initiates Phase 1b trial of SGN-CD33A
Seattle Genetics announced initiation of a phase 1b clinical trial of SGN-CD33A in combination with standard of care chemotherapy, including cytarabine and daunorubicin, for patients with newly diagnosed acute myeloid leukemia. The trial will also evaluate SGN-CD33A in the consolidation setting for AML, both in combination with cytarabine and as a single-agent maintenance regimen. SGN-CD33A is a novel antibody-drug conjugate targeted to CD33 utilizing Seattle Genetics’ newest technology. CD33 is expressed on most AML cells regardless of subtype, cytogenetic abnormality or underlying mutational heterogeneity. SGN-CD33A is also under evaluation in an ongoing phase 1 dose escalation trial as a single-agent or in combination with hypomethylating agents for the treatment of patients who have relapsed AML or have declined intensive frontline therapy. The study is a phase 1b, open-label, multi-center, dose-escalation clinical trial designed to evaluate SGN-CD33A administered in combination with frontline standard of care regimens for induction (cytarabine and daunorubicin) and/or consolidation. In addition, the study will evaluate single-agent SGN-CD33A as a maintenance regimen. The primary endpoints are determination of the maximum tolerated dose and safety profile of SGN-CD33A in these settings. In addition, the trial will evaluate anti-leukemic activity, pharmacokinetics, progression-free survival and overall survival. The phase 1b trial will enroll approximately 90 patients at multiple centers in the United States.

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