Pasithea Therapeutics (KTTA) said Thursday that the external Safety Review Committee recommended that the company's phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor, in advanced cancer should proceed to cohort 6, 30mg capsules, without any modification.
The recommendation was based on the review of the safety data from three patients from cohort 5 and the absence of any dose limiting toxicities, or DLT, the biotechnology company said.
During the DLT period, no rash was observed to date in any of the first 19 patients in either capsule or tablet formulation of PAS-004. Rash is a common adverse event that is observed at low doses with competitor MEK inhibitors, Pasithea said.
Shares were up 50% in early Thursday trading.
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