Core Viewpoint - Pasithea Therapeutics Corp. is advancing its Phase 1 clinical trial of PAS-004, a macrocyclic MEK inhibitor, for treating neurofibromatosis type 1 (NF1) and other advanced solid tumors, following a positive safety review by an independent committee [1][2][3] Group 1: Clinical Trial Progress - The independent Safety Review Committee (SRC) has completed its safety review of the first dose cohort (2mg) and recommended escalating to the next dose level (4mg) due to the absence of dose limiting toxicities (DLTs) [2] - Enrollment and initial dosing of 3 patients in the second cohort at 4mg has been completed following the SRC's recommendation [2][3] - The Phase 1 trial is a multicenter, open-label, dose escalation study focusing on the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in patients with specific mutations or those who have failed previous treatments [3] Group 2: Company Overview - Pasithea Therapeutics is a biotechnology company dedicated to developing innovative treatments for central nervous system (CNS) disorders and RASopathies, with a focus on conditions like NF1, solid tumors, and amyotrophic lateral sclerosis (ALS) [9]
Pasithea Therapeutics Announces Completion of Enrollment and Initial Dosing of Cohort 2 following Positive Safety Review Committee (SRC) Recommendation for PAS-004 in Ongoing Phase 1 Clinical Trial