16 Sep 2020
Menarini Ricerche Announces Initiation of Cohort Expansion for the Clinical Study of SEL24/MEN1703 in Acute Myeloid Leukemia
First patient treated in Europe into the expansion cohort of Phase I/II DIAMOND-01 trial
Pomezia, Italy, September 16th, 2020 – Menarini Ricerche, the R&D division of the Menarini Group, announced today that it has treated the first patient in Europe for the cohort expansion part of DIAMOND-01 clinical trial (CLI24-001; NCT03008187) investigating SEL24/MEN1703, a first-in-class, oral dual PIM/FLT3 inhibitor, as the single agent in Acute Myeloid Leukemia (AML). The patient has been dosed into the expansion cohort after the completion of the dose escalation part of the trial, the results of which have been presented at the most recent 25th Annual Meeting of the European Hematology Association (EHA). The above cohort expansion had already started in the US, with the first patient being treated as of 21 July 2020.
DIAMOND-01 is a first-in-Human, Phase I/II dose escalation and cohort expansion trial of SEL24/MEN1703 in AML – relapsed or refractory as well as previously untreated patients unsuitable for chemotherapy. The expansion cohort, which will be run in major oncology centers both in the US and in Europe (Italy, Spain and Poland) and will enroll patients with relapsed or refractory AML, will further evaluate the single agent activity and the safety profile of SEL24/MEN1703 at the recommended dose as determined in the dose escalation part of the study.