Pasithea Therapeutics Drug Shows Tumor Reduction In Pancreatic Cancer, Strong Early Trial Results

Core Viewpoint - Pasithea Therapeutics Corp. has released promising interim pharmacodynamic data from its ongoing Phase 1 trial of PAS-004 in advanced cancer patients, leading to a significant increase in stock price during premarket trading [1][7]. Group 1: Clinical Trial Data - The Phase 1 trial evaluated different dosages of PAS-004, including 8mg, 15mg capsules, and 4mg tablets, with a focus on pharmacodynamic (PD) activity [1][4]. - Strong target engagement was demonstrated, with pERK levels showing reductions of up to 91% at the 8mg dose, indicating substantial target engagement in patients [2][4]. - Encouraging preliminary clinical observations were noted, with several patients achieving stable disease and tumor shrinkage while on PAS-004 treatment [4]. Group 2: Patient Outcomes - A notable case involved a patient with stage 4 KRAS G12R-mutated pancreatic cancer who experienced a tumor volume reduction of -9.8% over 5 months of treatment with the 15mg capsule [5]. - The external Safety Review Committee recommended proceeding to Cohort 6 (30mg capsule) based on safety data from previous cohorts, with no dose-limiting toxicities reported [6]. Group 3: Market Reaction - Following the release of the trial data, KTTA stock rose by 62.7%, reaching $2.33 during the premarket session [7].