On September 16, 2020 Menarini Ricerche, the R&D division of the Menarini Group, reported that a first patient in Europe has been treated in the cohort expansion phase of the DIAMOND clinical trial -01 (CLI24-001; NCT03008187), investigating SEL24 / MEN1703, a first-in-class dual oral PIM / FLT3 inhibitor, as a monotherapy agent in acute myeloid leukemia (AML) (Press release, Menarini, SEP 16, 2020, View Source [SID1234565260]). The patient has received the assigned treatment in the expansion phase of the cohort, which has been initiated after the end of the dose escalation phase of the trial, the results of which have been presented at the 25th annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper). The aforementioned cohort expansion phase began previously in the United States, with a first patient treated on July 21, 2020.

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DIAMOND-01 is a phase I-II trial, first administration to humans, in a dose escalation and cohort expansion design, to evaluate SEL24 / MEN1703,, in patients with recurrent or refractory AML, as well as patients who do not have been previously treated because they are not candidates for standard chemotherapy The expansion of the cohort, which has been implemented in various centers of excellence in oncology in the United States and Europe (Italy, Spain and Poland), will recruit patients with recurrent AML or refractory, and will evaluate the monotherapy activity and the safety profile of SEL24 / MEN1703 at the recommended dose, determined according to the results of the dose escalation phase.