Pasithea Therapeutics Announces Opening of European Clinical Trial Sites and Completes Initial Dosing of Cohort 4

On January 14, 2025 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 cancer indications, reported it has opened three clinical trial sites in Eastern Europe (Press release, Pasithea Therapeutics, JAN 14, 2025, View Source [SID1234649712]). These sites in Romania and Bulgaria are actively recruiting patients along with the four open sites in the United States, for Pasithea’s PAS-004 Phase 1 trial.

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In Eastern Europe, Pasithea is working with Arensia Exploratory Medicine, Institute of Oncology Bucharest, Arensia Exploratory Medicine, Institute of Oncology Cluj-Napoca, and Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia- EOOD.

In addition, Pasithea has completed initial dosing of three patients in Cohort 4A (15mg capsule). Patient recruitment for Cohort 4B is ongoing (4mg tablet). The Company plans to present interim safety and pharmacokinetic (PK) data from Cohorts 4A and 4B in Q1 2025.

Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea stated, "We are pleased to be working with Arensia in Eastern Europe, allowing PAS-004 to be tested in patients with tumor types more sensitive to single agent MEK treatment or patients who have previously failed first-generation MEK inhibitors."

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose-escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy 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 (NCT06299839).