Pasithea Therapeutics progresses with cancer drug trial

MIAMI - Pasithea Therapeutics Corp. (NASDAQ: KTTA), a biotech firm focused on central nervous system disorders and cancer with a current market capitalization of approximately $3 million, has received a nod from its external Safety Review Committee to advance its Phase 1 clinical trial of PAS-004 to the next dosage level. According to InvestingPro analysis, the company appears undervalued based on its Fair Value estimates. This decision, announced today, allows the trial to proceed to a 30mg capsule dosage without any changes to the protocol.

The recommendation came after reviewing safety data from three patients in the preceding cohort and finding no dose-limiting toxicities or instances of rash, a common side effect associated with similar medications. To date, no rashes have occurred in the first 19 patients, spanning both capsule and tablet formulations of PAS-004. While the clinical progress is promising, InvestingPro data shows the company is quickly burning through cash, with a negative free cash flow yield, though it maintains a strong current ratio of 6.58x.

Pasithea's CEO, Dr. Tiago Reis Marques, highlighted the strong enrollment demand and the company's anticipation of providing additional safety, pharmacokinetic, and pharmacodynamic data in the coming weeks. Marques also noted the high discontinuation rates due to rash with approved MEK inhibitors for neurofibromatosis type 1 (NF1), exceeding 80%, a side effect not observed with PAS-004 thus far.

The ongoing trial is a multi-center, open-label study designed to assess the safety, tolerability, and preliminary efficacy of PAS-004 in patients with advanced solid tumors driven by MAPK pathway mutations or those who have not responded to BRAF/MEK inhibition.

Pasithea Therapeutics is developing treatments for neurological disorders, including NF1, solid tumors, and Amyotrophic Lateral Sclerosis (ALS), with a team of neuroscience, translational medicine, and drug development experts.

The information in this article is based on a press release statement. Pasithea has made forward-looking statements regarding the trial's future outcomes, but these are subject to numerous conditions and risks, as outlined in their filings with the U.S. Securities and Exchange Commission. InvestingPro subscribers have access to 10 additional key insights about KTTA's financial health and market position, along with real-time updates on its financial metrics and valuation. Pasithea cautions against placing undue reliance on these forward-looking statements, which are based on current estimates and assumptions and may differ materially from future results.

In other recent news, Pasithea Therapeutics Corp. announced the advancement of its Phase 1 clinical trial for PAS-004, a treatment targeting advanced cancers with MAPK pathway mutations. The trial will now proceed to a higher dose level following a favorable safety review. The Safety Review Committee noted no dose-limiting toxicities among the first 14 patients, and importantly, no incidences of rash were reported, a common side effect seen with competitor MEK inhibitors. This development suggests a promising safety profile for PAS-004, which is a macrocyclic MEK inhibitor with a half-life exceeding 60 hours. The ongoing study is a multi-center, open-label trial designed to evaluate the safety and efficacy of PAS-004 in patients with advanced solid tumors. Pasithea plans to present updated pharmacokinetic and pharmacodynamic data in the first quarter of 2025. These recent developments reflect Pasithea's progress in cancer treatment research.

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