FDA lifts partial hold on Curis' TakeAim leukemia study

The US Food and Drug Administration (FDA) has removed the partial clinical hold on the TakeAim Leukemia Phase I/II study of emavusertib for the treatment of hematologic malignancies, conducted by US biotech Curis (Nasdaq: CRIS), whose shares closed up 4.5% at $0.86 following the news.

Furthermore, the recommended Phase II dose (RP2D) for emavusertib as a monotherapy has been established at 300mg BID in patients with acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS).

"We are pleased to announce that FDA has removed the partial clinical hold on the TakeAim Leukemia study and that we are proceeding with 300mg BID as our RP2D. We are working with our clinical sites to enroll targeted patients with AML (patients with a FLT3 or spliceosome mutation who have received ≤ 2 prior lines of treatment). We also plan to initiate a front-line combination study of emavusertib with azacitidine and venetoclax. We believe emavusertib has the potential to be the cornerstone agent in the treatment of hematological malignancies," said James Dentzer, president and chief executive of Curis.