On June 13, 2024 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other indications, reported that an independent Safety Review Committee (SRC) has completed its safety review of data from the first dose cohort (2mg) treated in the ongoing Phase 1 clinical trial (NCT06299839) 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 (Press release, Pasithea Therapeutics, JUN 13, 2024, View Source [SID1234644304]).
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Based on these findings, 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 (DLT’s) 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.
Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea stated, "We are pleased to have rapidly enrolled and completed first dosing of the participants in the second cohort following the SRC’s positive recommendation to advance to 4mg of PAS-004. We look forward to continuing to develop PAS-004 as a potential treatment for solid tumors as well as cutaneous and plexiform neurofibromas in NF1 patients. We remain on track to present our initial safety and pharmacokinetic (PK) data in the third quarter of 2024."
The Phase 1 trial is a multicenter, open-label, dose escalation study evaluating the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) 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 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 (efficacy) of PAS-004 and defining the preliminary recommended Phase 2 dose(s).