By Chris Wack
Pasithea Therapeutics shares were up 67% to $3.46 in premarket trading after the company said that an external safety review committee recommended that its Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to cohort 5, 22mg capsule, without modification.
The biotechnology company said that this recommendation was based on the review of the safety data from three patients in cohort 4A, 15mg capsule, and the absence of any dose limiting toxicities.
The Miami company also said that no rash had been observed to date in any of the first 14 patients who have been dosed with PAS-004 in either capsule or tablet formulation. Rash is a common adverse event that is observed at low doses with competitor inhibitors and may lead to the high discontinuation rate in real world practice.
The continuing Phase 1 clinical trial is a multicenter, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy of PAS-004 in patients with advanced solid tumors.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
February 05, 2025 09:04 ET (14:04 GMT)
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