Pasithea Therapeutics Receives Positive SRC Recommendation for its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer
DENVER, Colo., Feb 05, 2025 (247marketnews.com)- Pasithea Therapeutics (NASDAQ:KTTA) reported that its Phase 1 clinical trial of PAS-004 in advanced cancer received a recommendation from the external Safety Review Committee (SRC) to escalate to the next dose level, a 22mg capsule, without any modifications. This recommendation follows the review of safety data from three patients in cohort 4A (15mg capsule), where no dose-limiting toxicities (DLTs) or rash were observed. Additionally, no rash, a common side effect with other MEK inhibitors, was seen in any of the 14 patients dosed with PAS-004 in either capsule or tablet formulations.
The trial, which targets patients with advanced solid tumors driven by MAPK pathway mutations (RAS, NF1, or RAF), aims to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004.
Dr. Tiago Reis Marques, Pasithea’s CEO, commented, “As we are observing substantial exposure levels of PAS-004, we remain encouraged by the safety profile PAS-004 continues to exhibit. With the differentiated profile of PAS-004, we believe it is possible that this highly specific macrocyclic MEK inhibitor with a half life of greater than 60 hours may change the treatment paradigm for patients with NF1 and inoperable plexiform neurofibromas. We are looking forward to presenting updated pharmakokinetic (PK) and pharmacodynamic (PD) data during Q1 2025.”
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