Clinical Trial Progress - Pasithea Therapeutics has opened three new clinical trial sites in Eastern Europe, specifically in Romania and Bulgaria, in addition to the four existing sites in the United States for the PAS-004 Phase 1 trial [1] - The company has completed initial dosing of three patients in Cohort 4A (15mg capsule) and is actively recruiting patients for Cohort 4B (4mg tablet) [3] - Interim safety and pharmacokinetic (PK) data from Cohorts 4A and 4B are expected to be presented in Q1 2025 [3] Partnerships and Collaborations - Pasithea is collaborating with Arensia Exploratory Medicine and several oncology institutes in Eastern Europe, including the Institute of Oncology Bucharest, Institute of Oncology Cluj-Napoca, and Multiprofile Hospital for Active Treatment Sveta Sofia- EOOD [2] Trial Design and Objectives - The ongoing Phase 1 clinical trial is a multi-center, open-label, dose-escalation 3+3 study designed to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 [4] - The trial focuses on patients with MAPK pathway-driven advanced solid tumors with documented RAS, NF1, or RAF mutations, or those who have failed BRAF/MEK inhibition [4] Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications [1] - The company is focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders and RASopathies, including NF1, solid tumors, and Amyotrophic Lateral Sclerosis (ALS) [5]
Pasithea Therapeutics Announces Opening of European Clinical Trial Sites and Completes Initial Dosing of Cohort 4