EPI-506 was generally well-tolerated with a favorable safety profile across all doses up to 2400 mg. At a dose of 3600 mg, gastrointestinal adverse events (nausea, vomiting, abdominal pain) were observed in two patients: one patient in the once-daily ("QD") dosing cohort and one patient in the 1800 mg twice-daily dosing cohort, leading to study discontinuation and dose-limiting toxicity ("DLT") due to >25% missed doses in the 28-day safety reporting period. A separate patient in the 3600 mg QD cohort experienced a transient Grade 3 increase in liver enzymes (AST/ALT), which also constitutes a DLT, so enrollment was concluded in that cohort.
The unuasually high doses mentioned in prior posts on this board were telling.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”