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Pasithea Therapeutics Says Interim Phase 1 Data for PAS-004 Show Durable Clinical Activity

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Pasithea Therapeutics (KTTA) said interim data from an ongoing Phase 1 trial of PAS-004 showed a favorable safety profile and durable clinical activity in patients with MAPK pathway-driven advanced solid tumors.

The company said the interim results were based on 34 patients enrolled and dosed through May 22.

The company said all treatment-related adverse events were Grade 1 or 2, with no dose-limiting toxicities, no treatment discontinuations due to treatment-related adverse events, and no treatment-related cardiac or retinal toxicities.

Several patients, including some previously treated with MEK/BRAF inhibitors, remained on therapy for more than six months, with two treated for more than one year, Pasithea Therapeutics said.

Pasithea Therapeutics also amended the trial protocol to continue dose escalation using a tablet formulation at doses of up to 52 mg, and initiated an optional pilot food-effect assessment, the company said.

Shares of the company were up 1.1% in Tuesday premarket trading.

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