Pasithea Therapeutics begins dosing cohort 2 in Phase 1 trial of PAS-004

Pasithea Therapeutics announced that an independent Safety Review Committee has completed its safety review of data from the first dose cohort treated in the ongoing Phase 1 clinical trial of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition. The SRC recommended that the trial escalate to the next dose level – 4mg – without modifications. This recommendation was based on the absence of any dose limiting toxicities or clinically relevant treatment-emergent adverse events in the initial cohort of 3 patients. The company has now completed enrollment and initial dosing of 3 patients in the second cohort. The company expects to present initial safety and pharmacokinetic data in Q3. The primary objective of the study is to assess the safety and tolerability of PAS-004, with secondary objectives including PK and PD parameters, an evaluation of the preliminary anticancer activity of PAS-004 and defining the preliminary recommended Phase 2 dose.