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BRIEF-Seattle Genetics announces clinical hold on several phase 1 trials of Vadastuximab Talirine
December 27, 2016 / 1:15 PM / 7 months ago

BRIEF-Seattle Genetics announces clinical hold on several phase 1 trials of Vadastuximab Talirine

2 Min Read

Dec 27 (Reuters) - Seattle Genetics Inc

* Seattle Genetics announces clinical hold on several phase 1 trials of Vadastuximab Talirine (SGN-CD33A)

* Enrollment continues on phase 3 cascade trial in acute myeloid leukemia and phase 1/2 trial in myelodysplastic syndrome

* Clinical holds were initiated to evaluate potential risk of hepatotoxicity in patients who were treated with SGN-CD33A

* Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events

* Two phase 1 trials have been placed on partial clinical hold

* Clinical holds initiated to evaluate risk of hepatotoxicity in patients who got allogeneic stem cell transplant before or after treatment

* Phase 1/2 trial of SGN-CD33A monotherapy in pre- and post-allogeneic transplant aml patients has been placed on full clinical hold

* No new studies will be initiated until clinical holds are lifted

* Seattle genetics announces clinical hold on several phase 1 trials of Vadastuximab Talirine (SGN-CD33A) Source text for Eikon: Further company coverage:

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