08:01 AM EDT, 08/18/2025 (MT Newswires) -- Aptose Biosciences ( APTOF ) on Monday said the latest data update from the Phase 1/2 Tuscany trial in newly diagnosed acute myeloid leukemia (AML) patients show no significant safety concerns with different dose levels of the company's lead candidate, tuspetinib.
The trial was initiated last December. Data from 10 patients across all three dose cohorts, 40 mg, 80 mg or 120 mg, support the use of tuspetinib with the usual standard of care treatment across all AML populations, including those carrying mutations that are the most difficult to treat, a statement said.
At the 120 mg tuspetinib dose level in combination with venetoclax and azacitidine, no significant safety concerns or dose limiting toxicities were observed. Nine out of 10 dosed patients remain in the study across all dose cohorts and enrollment is being advanced to the 160 mg tuspetinib dose level following the Cohort Safety Review Committee meeting.
"We already have data from three different TUS dose levels in the TUSCANY trial, and the data continue to strengthen at higher doses of TUS and over time. We are building a strong case for TUS+VEN+AZA as a triplet frontline therapy of choice to address a broad AML population, including subgroups with the most adverse of mutations," said William Rice, chief executive officer of Aptose.