Pasithea Therapeutics (KTTA) amended the protocol for its phase 1/1b trial of PAS-004 in neurofibromatosis type 1 patients with symptomatic inoperable, incompletely resected or recurrent plexiform neurofibromas, the company said Tuesday.
The amended protocol adds higher dose levels of 24 mg and 32 mg, allows evaluation of intermediate doses and extends treatment in the dose-escalation portion of the study to up to 18 months, Pasithea Therapeutics said.
The company has completed enrollment and multi-cycle dosing in the 4 mg, 8 mg, 12 mg and 18 mg cohorts and has enrolled patients in the 15 mg and 24 mg cohorts, it said.
Pasithea Therapeutics said it remains on track to provide an interim update from the trial in Q4.
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