Promising Interim Results for PAS-004 in Cancer Treatment

Promising Interim Results for PAS-004 in Cancer Treatment

Pasithea Therapeutics Corp. (NASDAQ: KTTA) has recently shared compelling data regarding its drug candidate, PAS-004, during a poster presentation at the prestigious American Society of Clinical Oncology (ASCO) Annual Meeting 2025. This next-generation macrocyclic MEK inhibitor shows promise as a treatment for advanced solid tumors, particularly for patients who have undergone extensive previous therapies.

Initial Observations of PAS-004

The results demonstrate encouraging preliminary clinical activity indicating that PAS-004 may be effective as a standalone treatment for heavily pre-treated patients with refractory solid tumors. Among those treated, significant milestones have been achieved, especially in cohort 4A, where a patient with stage 4 BRAF-mutated melanoma exhibited over five months of stable disease, showcasing a tumor volume reduction of -14.9%. This patient's journey underscores the potential impact PAS-004 could have on those battling aggressive cancer forms.

Dose Escalation Study Overview

The ongoing Phase 1 study, designed as a multi-center, open-label trial, examines the safety and efficacy of PAS-004. As it progresses, researchers are particularly focused on the drug's pharmacokinetic (PK) and pharmacodynamic (PD) profiles. As of the latest update, 21 patients have been enrolled across various dosage levels, which have included capsules ranging from 2mg to 22mg, and 4mg tablets. Notably, pancreatic and colorectal cancers are the most common diagnoses among participants.

Safety Profile of PAS-004

PAS-004 has maintained a favorable safety profile throughout the study, with all treatment-related adverse events reported as either grade 1 or grade 2. Importantly, no severe dose-limiting toxicities (DLTs) have been encountered, allowing for ongoing dose escalation. The absence of known MEK inhibitor class-related adverse events, such as ocular or skin toxicities, further emphasizes its potential as a well-tolerated treatment option.

Clinical Efficacy and Advancements

Analyzing the pharmacokinetics of PAS-004, preliminary data suggests a linear PK profile, with an estimated half-life exceeding 60 hours. This indicates a promising engagement with targeted pathways, potentially greater than previously observed in earlier cohorts. Early evaluations also reveal stable disease metrics, with some patients enjoying progression-free survival for periods extending up to 159 days and overall survival rates reaching 253 days.

Exciting Developments in the FIELD

Dr. Tiago Reis Marques, the Chief Executive Officer of Pasithea, highlighted the transformative potential of MEK inhibitors, including PAS-004. He noted the growing momentum within the field, with over 15 data sets related to MEK inhibitors presented at ASCO 2025 alone. The recent approval of additional MEK inhibitors indicates the innovative shifts occurring within cancer treatment landscapes.

Implications for Future Therapies

As a macrocyclic compound, PAS-004 represents a significant advancement, offering high selectivity and sustained pathway suppression while retaining good tolerability. This characteristic positions PAS-004 as a potential game-changer for both monotherapy and combination therapies for patients who have not responded to previous treatments. The excitement surrounding PAS-004 reflects not only its immediate applications but also its broader implications for future oncology treatments.

Availability of More Information

For those interested in the detailed findings from the ASCO presentation, Pasithea will make the poster available on its official website, providing further insights into this important research.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics is a dedicated clinical-stage biotechnology company focusing on the innovative research and development of PAS-004 and other MEK inhibitors aimed at treating RASopathies and MAPK pathway-driven tumors. Currently, the company is advancing PAS-004 through Phase 1 clinical trials in advanced cancer patients and those suffering from neurofibromatosis type 1.

Frequently Asked Questions

What is PAS-004?

PAS-004 is a macrocyclic MEK inhibitor developed by Pasithea Therapeutics intended to treat advanced solid tumors and RASopathies.

How is the Phase 1 study structured?

The trial is a multi-center, open-label, dose escalation study aimed at evaluating the safety and efficacy of PAS-004 in cancer patients.

What were the outcomes presented at ASCO 2025?

The data revealed promising stability and tumor reduction in patients using PAS-004, with no significant adverse events reported.

Who is the key leader at Pasithea Therapeutics?

Dr. Tiago Reis Marques serves as the CEO and has been vocal about the potential of PAS-004 in transforming cancer treatment.

Where can I find more information?

Detailed findings from the ASCO presentation will be available on Pasithea's official website.

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