Promising Results for Pasithea's PAS-004 in Advanced Cancer Trials
Pasithea Therapeutics Reports Positive Developments in PAS-004 Trials
In a recent announcement, Pasithea Therapeutics Corp. (NASDAQ: KTTA) shared impressive data from its ongoing Phase 1 clinical trial of PAS-004, a cutting-edge macrocyclic MEK inhibitor targeting advanced cancer treatment. This clinical trial investigates the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of PAS-004 in patients suffering from solid tumors driven by the MAPK pathway with notable mutations.
Trial Overview
The trials are being conducted at several clinical locations across the United States as part of an open-label, multi-center, dose-escalation study. Participants in the trial have advanced solid tumors linked to specific mutations in RAS, NF1, or RAF pathways, or have previously failed treatments with BRAF/MEK inhibitors.
Safety and Tolerability Insights
Pasithea's latest report reveals encouraging safety outcomes with no treatment-related adverse events (TRAEs) or dose-limiting toxicities (DLTs) reported in the initial dosing groups. Patients have generally tolerated PAS-004 well, with no serious adverse events noted at either the 2mg or 4mg dosing levels. The absence of typical side effects associated with MEK inhibitors, such as skin rashes or gastrointestinal issues, is particularly promising.
Pharmacokinetics and Efficacy
A significant feature of PAS-004 is its long half-life of approximately 70 hours. This trait supports less frequent oral dosing, potentially paving the way for a more manageable treatment regimen. Initial pharmacokinetic data indicates a stable drug concentration in the plasma, allowing for consistent target inhibition with minimal fluctuation.
Early Efficacy Indicators
Remarkably, one patient in the 2mg cohort, suffering from stage 3 colon cancer and having undergone four previous therapeutic lines, has reached a prolonged period of stable disease while continuing on PAS-004 into the sixth dosing cycle. This preliminary data suggests that despite the harsh nature of the patient's illness and previous treatments, PAS-004 has provided noteworthy stabilization, an essential indicator of potential efficacy in advanced cancer care.
PAS-004: Different from Other MEK Inhibitors
Unlike first-generation MEK inhibitors that require twice-daily administration and exhibit shorter half-lives, the pharmacological profile of PAS-004 may offer unique advantages. The ability to maintain a steady plasma concentration at lower risk for peak-related toxicities suggests that PAS-004 could address safety concerns that plague other therapeutics in this category.
Company's Vision and Future Steps
The leadership at Pasithea, including CEO Dr. Tiago Reis Marques, has expressed excitement about the future potential of PAS-004. The upcoming Phase 1 results will allow them to further explore how PAS-004 can be employed not just in neurofibromatosis type 1 (NF1) treatment but also across a wider spectrum of cancer-related conditions.
About Pasithea Therapeutics Corp.
Pasithea is dedicated to the research and development of innovative therapies for disorders affecting the central nervous system (CNS) and RASopathies. Their portfolio reflects a commitment to addressing unmet medical needs, particularly in the domains of neuroscience and oncology. The experienced team behind Pasithea stands ready to leverage PAS-004’s promising profile toward advancing treatment opportunities.
Frequently Asked Questions
What is PAS-004 used for?
PAS-004 is a next-generation MEK inhibitor designed for treating advanced cancers and conditions like neurofibromatosis type 1 (NF1).
How was the safety and tolerability of PAS-004 assessed?
The safety of PAS-004 was assessed during a multi-center Phase 1 clinical trial, showcasing no significant adverse events reported to date.
What are the results from the latest Phase 1 clinical trial?
The recent trial results indicate that PAS-004 has demonstrated a favorable safety profile, effective pharmacokinetics, and early signs of efficacy in patients.
What differentiates PAS-004 from earlier MEK inhibitors?
PAS-004 features a significantly longer half-life, supporting once-daily dosing and reducing the risk of peak plasma toxicities commonly associated with earlier MEK inhibitors.
How can one get in touch with Pasithea Therapeutics?
For inquiries, you can contact Patrick Gaynes, Corporate Communications, via email at pgaynes@pasithea.com.
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