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Tag: Pasithea Therapeutics Stock

  • Pasithea (KTTA) Stock Spikes On Its Latest Clinical Trial Milestone

    Pasithea (KTTA) Stock Spikes On Its Latest Clinical Trial Milestone

    Pasithea Therapeutics Corp. (NASDAQ: KTTA) had a notable increase in its share price today, rising 34.13% to $2.79 as of the most recent check. This increase comes after the business said that an independent committee monitoring its current Phase 1 clinical study for PAS-004, an experimental therapy for advanced cancer, had given it a positive safety evaluation.

    Regulatory Approval to Advance PAS-004 Trial

    Pasithea Therapeutics revealed that its external Safety Review Committee has endorsed the progression of the PAS-004 trial to cohort 5, involving a 22mg capsule, without any modifications. This decision was based on a thorough evaluation of safety data from three patients in cohort 4A who received a 15mg dosage.

    Notably, no dose-limiting toxicities (DLTs) were identified, and none of the 14 patients treated thus far—12 receiving capsules and two administered tablets—exhibited rash, a common adverse effect associated with competitor MEK inhibitors that often leads to high discontinuation rates in clinical practice.

    Potential for a Transformative Treatment

    Pasithea is still hopeful about PAS-004’s ongoing safety profile as its unique pharmacokinetic properties make it a potentially game-changer for patients with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas. The company has documented significant exposure levels of the drug.

    As a highly specific macrocyclic MEK inhibitor with a half-life exceeding 60 hours, PAS-004 could offer an improved therapeutic alternative in these conditions. Pasithea has further announced plans to present updated pharmacokinetic (PK) and pharmacodynamic (PD) data during the first quarter of 2025.

    Expansion of Clinical Trials in Eastern Europe

    To support the ongoing Phase 1 trial, KTTA has expanded its clinical research footprint by opening three trial sites in Eastern Europe, located in Romania and Bulgaria. These sites are actively enrolling patients alongside four existing U.S. trial locations.

    Pasithea (KTTA) is collaborating with Arensia Exploratory Medicine at multiple institutions, including the Institute of Oncology Bucharest, the Institute of Oncology Cluj-Napoca, and the Multiprofile Hospital for Active Treatment Sveta Sofia-EOOD. At the time of reporting, the company had completed initial dosing for three patients in Cohort 4A and was continuing recruitment for Cohort 4B.

  • Pasithea Therapeutics (KTTA) Sees Strong Pre-Market Gains

    Pasithea Therapeutics (KTTA) Sees Strong Pre-Market Gains

    Pasithea Therapeutics Corp. (NASDAQ: KTTA) shares are gaining significantly traction in the pre-market session today, following the release of promising interim data from its ongoing clinical trials. As of the latest check, KTTA stock saw a remarkable rise, trading at $6.11, representing a 58.91% increase from its previous close on US stock charts.

    Pasithea Shared Encouraging Clinical-Trial Results

    Pasithea (KTTA) published data from the first phase of clinical trials for PAS-004, which covered pharmacokinetics (PK), safety, and tolerability. PAS-004, a potential treatment for advanced solid tumors triggered by the MAPK pathway, is being investigated in this experiment at four US clinical sites.

    These malignancies include those in which BRAF/MEK treatments have been ineffective and those with confirmed mutations in RAS, NF1, or RAF. Preliminary efficacy assessment of PAS-004, safety, tolerability, PK, and pharmacodynamics (PD) are the main areas of emphasis of this open-label, multi-center trial.

    PAS-004: A Potential Next-Generation MEK Inhibitor

    The clinical data has shown that PAS-004 exhibits a unique PK and safety profile, positioning it as a next-generation MEK inhibitor. Unlike typical MEK inhibitors, which often cause adverse side effects like rash or gastrointestinal toxicity even at low doses, PAS-004 has demonstrated a favorable safety profile. Notably, no such side effects have been observed, and the drug has maintained high exposure levels, further enhancing its potential in treatment.

    With a half-life of approximately 70 hours, PAS-004 provides a steady inhibition of target pathways, avoiding the peak plasma toxicities that are common among other MEK inhibitors. This characteristic makes it particularly suitable for treating conditions like Neurofibromatosis type 1 (NF1).

    KTTA Observed Early Signs of Efficacy and Future Potential

    Additionally, Pasithea reported encouraging early efficacy signs, including a colorectal cancer patient with a BRAF K601E mutation showing prolonged stable disease after receiving continuous treatment through the 6th 28-day dosing cycle. This patient’s response highlights PAS-004’s potential to outperform current MEK inhibitors in both safety and effectiveness.

    Pasithea aims to develop PAS-004 as a less frequent dosing option, potentially applicable beyond NF1 to other conditions.