Pasithea Therapeutics Gets Positive Response From FDA Meeting for Rare Cancer Treatment

By Chris Wack

Pasithea Therapeutics received positive written responses to questions submitted for a meeting with the U.S. Food and Drug Administration regarding the clinical development plan for PAS-004, a potential treatment for rare tumors.

The FDA's positive feedback and guidance include a recommendation to begin dosing in patients who will benefit from treatment rather than in healthy volunteers.

PAS-004 was granted orphan drug designation for the treatment of neurofibromatosis type 1 in November 2020.

Pasithea said it is on track to submit an application for studying PAS-004 in clinical trials in the current quarter.

After FDA acceptance of the application, the biotechnology company plans to begin testing PAS-004 in a first-in-human Phase 1 dose escalation trial in advanced solid tumor patients with RAS, RAF and NF1 mutations including KRAS, NRAS, BRAF and NF1 mutations as early as the first quarter of 2024.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

11-29-23 0854ET