On 16 December 2017, Selvita announced that the FDA had lifted the clinical hold on the Phase I/II clinical trial with the company’s lead drug candidate SEL24 (dual PIM/FLT3 kinase inhibitor) for refractory/relapsed acute myeloid leukaemia (r/r AML). The asset is now out-licensed to Menarini Group, therefore the two companies worked together with the FDA to resolve the issues. The trial can now be restarted with some modifications to the design. While only few details have been disclosed, Selvita (WA:SLVP) mentioned that the dose-finding scheme will be revised to the usual “3+3” design and the trial will resume.
Modification to dose escalation Part 1
As a reminder, the clinical hold was announced on 7 October 2017 after a fatal venous haemorrhagic stroke post thrombosis in one patient enrolled in the cohort 5 in Part 1 of the study. The stroke was classified as possibly related to the study treatment, which prompted the FDA to issue the clinical hold. The fatal stroke was associated with the treatment mainly because of the timing (the patient received four doses of SEL24); however, to actually prove it or disprove it is not straightforward, in our view, as AML patients already can have thrombosis risk factors. According to the original clinical trial design, the dose-finding Part 1 of the study had an accelerated dose escalation design, which will now be switched to the more comprehensive standard “3+3”, and restarted with a lower dose. According to Selvita, this could delay the study by around six months, which in oncology R&D is not very substantial, in our view. As previously stated, Menarini should take over the development as the study resumes. The study is expected to be completed by around end-2018.
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