subslover
2 days ago
Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer
SRC recommended that the trial escalate to the next dose level of 22mg capsule
No dose-limiting toxicities (DLTβs) or rash observed to date in either capsule or tablet formulations
MIAMI, Feb. 05, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (βPasitheaβ or the βCompanyβ), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced that the external Safety Review Committee recommended that the Companyβs Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to cohort 5, 22mg capsule, without modification. This recommendation was based on the review of the safety data from three patients in cohort 4A (15mg capsule) and the absence of any dose limiting toxicities (DLTβs). In addition, no rash has been observed to date in any of the first 14 patients who have been dosed with PAS-004 in either capsule (12 patients) or tablet (2 patients) formulation. Rash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the high discontinuation rate in real world practice.
βAs we are observing substantial exposure levels of PAS-004, we remain encouraged by the safety profile PAS-004 continues to exhibit,β stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. βWith 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.β
The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).
About Pasithea Therapeutics Corp.
PennyStockTrader2
4 months ago
Absolutely fantastic, timingwise my buyback was excellent, pricewise it was ok, bought back more than I had started with which I definitely hadnt planned for at the time, now have sold some in the pre-market, lets see where this goes, it could completely or partially retreat, trust me on that, hence why you must, I repeat must take some profits, how much profits and at what price is very very difficult to determine, but I use percentage move, 52 week hi/low, news or anticipation of future news, how much cash I need for other purchases etc. I try very hard not to use by lifetime average (profit or loss), its hard not to consider it, but I really try to distance myself from that - the market doesnt care what I paid for any shares and neither should I but still its hard. Look at price and where yu think price is going based on factors mentioned, etc. Where would I be out of the stock completely, possibly in the 9s somewhere, I would have to see how it moves, volume, etc. But let me say this for the Nth time - these biotech stocks retreat and usually there is no more news coming for months to support the price. If you can trade them at the lower end of their price history with any kind of success, you can effectively lower your average to the point that all the shares you have are free or very very cheap.
tw0122
4 months ago
Not bad up 50% now.. We are encouraged that this patient has been treated continuously into the 6th 28-day dosing cycle with no toxicities or AEs observed. While still early in clinical development, we believe PAS-004 is showing early signs of differentiation, indicating PAS-004 has the potential to outperform current MEK inhibitors in terms of safety, reduced administration frequency, and potentially efficacy. Our goal is to provide a once-daily or less frequent dosing treatment with broader application, not only for NF1 but also for other indications.β
Interim Phase 1 Results
Interim Phase 1 Results
Pharmacokinetics (PK)
Plasma exposure increased with an increase in dose and linear PK is observed
Long half-life of approximately 70 hours will allow for once daily dosing or longer intervals
Prolonged systemic exposure with minimal fluctuation in PAS-004 plasma concentration at steady state (Cmax/Cmin ratio of 1.2) indicates a potential to achieve constant target inhibition
PK plasma curve
At steady-state, drug levels peaked at about 5 hours with a geometric mean maximum concentration (Cmax) of 16.2 and 61.3 ng/mL for the 2 mg and 4 mg dose groups, respectively. The mean elimination half-life was 67.9 hours supporting once-daily or less frequent oral dosing.
βPAS-004 has demonstrated distinct properties that we believe are significant advantages for an oral MEK inhibitor. PAS-004 has a significantly longer half-life compared to early-generation MEK inhibitors, particularly those used for the treatment of NF1, which have half-lives of less than 8 hours. The ability to achieve prolonged plasma exposures, as reflected in stable plasma concentrations at steady state, may potentially allow PAS-004 to achieve efficacious doses with a favorable safety profile,β stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea.
Safety & Tolerability
No treatment-related adverse events (TRAEs) or dose limiting toxicities (DLTs) observed to date
In the first 2 dosing cohorts (n=6), PAS-004 was shown to be well-tolerated with a favorable safety profile with no drug-related dose interruptions, reductions or discontinuations. There were no drug-related serious AEs (SAE) in any dose arm and no protocol-defined stopping criteria were met. Importantly, at the 2 and 4 mg dose levels no rash or skin toxicity, gastro-intestinal (GI) toxicity, or ocular toxicity have been observed to date.
The study independent Safety Review Committee has completed its safety review of data from the second dose cohort of 4 mg and the Company has initiated cohort 3 dosing at an increased dose of 8 mg in capsules and has filed a protocol amendment to increase dosing schedule.
PAS-004 Demonstrates a Differentiated MEK Inhibitor Profile
Unlike first-generation MEK inhibitors for the treatment of NF1 that require twice-daily dosing (BID) and exhibit short half-lives (
boywonder1
6 months ago
Dena Greeves, I was never any SPZI. What a liar. Also, I do not know Andrew. Now, go pound the table somewhere else you egoistical moron! I despise your rhetoric as your deception is known in the OTC. The Truth, as no one listens to Dina,anymore. Get your facts straight, and your your hate speech. Dena would be a wonderful drag name, just saying! 98% of OTC markets are scams but there are players like you! STFU, and get on your knees you lippy fool.
dinogreeves
6 months ago
You want to talk about deception I see? You are seating on another scam, two names on that ticker that didn't settle with me, one name works for toxic funders in lieu of shares, are you also one of them? Are you working with Sterling too, I got your pump scam SPZ*I, what else did I expose idiot. Get your facts straight, you know nothing.
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