Positive Updates on Pasithea's Phase 1 Clinical Trial Progress

Positive Safety Review Committee Recommendation for PAS-004

Pasithea Therapeutics Corp. (NASDAQ: KTTA), a pioneering biotech firm, recently received an enthusiastic recommendation from its external Safety Review Committee (SRC) regarding the ongoing Phase 1 clinical trial of PAS-004, a promising treatment targeting advanced cancer. The SRC concluded that the trial can advance to the next dose level of 22mg capsules, highlighting the drug's well-tolerated safety profile.

What the SRC Review Means

The SRC's decision comes after an extensive analysis of safety data collected from three patients in cohort 4A, who were administered a 15mg capsule. Notably, there were no instances of dose-limiting toxicities (DLTs) or rash observed among the first 14 patients treated, a significant win in the face of many competitor MEK inhibitors that often come with serious side effects. The absence of rash – a common adverse event at lower doses – indicates a well-tolerated drug, boosting the potential for its continued development.

Insights from Pasithea's Leadership

Dr. Tiago Reis Marques, the Chief Executive Officer of Pasithea, expressed confidence regarding the trial outcomes. He emphasized that the ongoing results affirm the safety profile of PAS-004, despite the anticipation of complex clinical trials. "As we witness substantial exposure levels of PAS-004, we remain encouraged by its safety profile," commented Dr. Marques. He further noted that PAS-004's specific characteristics, including its half-life of over 60 hours, show promise in redefining treatment methodologies for conditions such as Neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas.

Clinical Trial Design and Expectations

The ongoing Phase 1 clinical trial employs a multi-center, open-label, dose escalation 3+3 study design. This innovative approach aims to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with advanced solid tumors. These patients must exhibit documented mutations in MAPK pathway genes such as RAS, NF1, or RAF, or have previously failed BRAF/MEK treatments.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics focuses on developing innovative solutions for central nervous system (CNS) disorders and RASopathies. With a diverse team of experts specializing in neuroscience and drug development, the company is on a quest to create new molecular entities that address various neurological conditions, including NF1 and Amyotrophic Lateral Sclerosis (ALS). Their vision reflects a commitment to improving the lives of patients grappling with these challenging maladies.

What’s Next for PAS-004?

Looking ahead, Pasithea plans to share updated pharmacokinetic and pharmacodynamic data in the near future. This commitment to transparency and continual data sharing reflects the company’s dedication to providing stakeholders with critical information about their drug development process.

Frequently Asked Questions

What is the main finding from the recent SRC recommendation?

The SRC recommended advancing the trial to the next dose level of 22mg capsules based on positive safety data.

What does the absence of DLTs indicate?

The absence of dose-limiting toxicities suggests that PAS-004 is well-tolerated among patients, increasing confidence in its safety profile.

What is PAS-004 used to treat?

PAS-004 is being developed as a treatment for advanced cancer and neurofibromatosis type 1 (NF1).

Who is leading Pasithea Therapeutics?

Dr. Tiago Reis Marques is the Chief Executive Officer of Pasithea Therapeutics.

What future data is Pasithea planning to release?

Pasithea aims to present updated pharmacokinetic and pharmacodynamic data in the near future, enhancing the understanding of PAS-004's performance.

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