Pasithea Therapeutics Corp. (NASDAQ: KTTA) had a notable increase in its share price today, rising 34.13% to $2.79 as of the most recent check. This increase comes after the business said that an independent committee monitoring its current Phase 1 clinical study for PAS-004, an experimental therapy for advanced cancer, had given it a positive safety evaluation.
Regulatory Approval to Advance PAS-004 Trial
Pasithea Therapeutics revealed that its external Safety Review Committee has endorsed the progression of the PAS-004 trial to cohort 5, involving a 22mg capsule, without any modifications. This decision was based on a thorough evaluation of safety data from three patients in cohort 4A who received a 15mg dosage.
Notably, no dose-limiting toxicities (DLTs) were identified, and none of the 14 patients treated thus far—12 receiving capsules and two administered tablets—exhibited rash, a common adverse effect associated with competitor MEK inhibitors that often leads to high discontinuation rates in clinical practice.
Potential for a Transformative Treatment
Pasithea is still hopeful about PAS-004’s ongoing safety profile as its unique pharmacokinetic properties make it a potentially game-changer for patients with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas. The company has documented significant exposure levels of the drug.
As a highly specific macrocyclic MEK inhibitor with a half-life exceeding 60 hours, PAS-004 could offer an improved therapeutic alternative in these conditions. Pasithea has further announced plans to present updated pharmacokinetic (PK) and pharmacodynamic (PD) data during the first quarter of 2025.
Expansion of Clinical Trials in Eastern Europe
To support the ongoing Phase 1 trial, KTTA has expanded its clinical research footprint by opening three trial sites in Eastern Europe, located in Romania and Bulgaria. These sites are actively enrolling patients alongside four existing U.S. trial locations.
Pasithea (KTTA) is collaborating with Arensia Exploratory Medicine at multiple institutions, including the Institute of Oncology Bucharest, the Institute of Oncology Cluj-Napoca, and the Multiprofile Hospital for Active Treatment Sveta Sofia-EOOD. At the time of reporting, the company had completed initial dosing for three patients in Cohort 4A and was continuing recruitment for Cohort 4B.