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On 7 October 2017, Selvita announced that the FDA has placed a full clinical hold on the company’s open-label, dose escalation Phase I/II clinical trial with SEL24 (dual PIM/FLT3 kinase inhibitor) in patients with relapsed/refractory acute myeloid leukemia (r/r AML). The decision was based on a fatal haemorrhagic stroke after venous thrombosis in one patient enrolled in the last cohort 5 in part 1 of the study designed to establish the recommended dose. The adverse event was classified as possibly related to the study treatment, which prompted the FDA to issue the clinical hold.

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