Pasithea Therapeutics Gets FDA Acceptance for PAS-004 IND Application
03 January 2024 - 1:17AM
Dow Jones News
By Chris Wack
Pasithea Therapeutics said it has received Investigational New
Drug Application clearance to proceed by the Federal Drug
Administration to evaluate PAS-004 in cancer patients.
Pasithea stock was halted at $7.40 in premarket trading on the
news.
PAS-004 is a macrocyclic MEK inhibitor for patients with
advanced solid tumors with a documented mutation or patients who
have failed BRAF/MEK inhibition.
Pasithea expects to dose the first patient in the first quarter
of 2024.
The objectives of the dose escalation study are to evaluate the
safety, tolerability, pharmacokinetics, and pharmacodynamics as
well as anti-tumor responses of PAS-004 as monotherapy in up to 36
advanced cancer patients, with preliminary early data expected as
early as the third quarter of 2024.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 02, 2024 09:02 ET (14:02 GMT)
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