Pasithea Therapeutics Announces Completion of Enrollment and Initial Dosing of Cohort 2 following Positive Safety Review Committee (SRC) Recommendation for PAS-004 in Ongoing Phase 1 Clinical Trial
13 Juin 2024 - 12:59PM
Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the
“Company”), a clinical-stage biotechnology company developing
PAS-004, a next-generation macrocyclic MEK inhibitor, for the
treatment of neurofibromatosis type 1 (NF1) and other indications,
announced today that an independent Safety Review Committee (SRC)
has completed its safety review of data from the first dose cohort
(2mg) treated in the ongoing Phase 1 clinical trial (NCT06299839)
of PAS-004 in patients with MAPK pathway driven advanced solid
tumors with a documented RAS, NF1 or RAF mutation or patients who
have failed BRAF/MEK inhibition.
Based on these findings, the SRC recommended
that the trial escalate to the next dose level (4mg) without
modifications. This recommendation was based on the absence of any
dose limiting toxicities (DLT’s) or clinically relevant
treatment-emergent adverse events in the initial cohort of 3
patients. The Company has now completed enrollment and initial
dosing of 3 patients in the second cohort.
Dr. Tiago Reis Marques, Chief Executive Officer
of Pasithea stated, "We are pleased to have rapidly enrolled and
completed first dosing of the participants in the second cohort
following the SRC's positive recommendation to advance to 4mg of
PAS-004. We look forward to continuing to develop PAS-004 as a
potential treatment for solid tumors as well as cutaneous and
plexiform neurofibromas in NF1 patients. We remain on track to
present our initial safety and pharmacokinetic (PK) data in the
third quarter of 2024."
The Phase 1 trial is a multicenter, open-label,
dose escalation study evaluating the safety, tolerability, and
pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004 in
patients with MAPK pathway driven advanced solid tumors with a
documented RAS, NF1 or RAF mutation or patients who have failed
BRAF/MEK inhibition. The primary objective of the study is to
assess the safety and tolerability of PAS-004, with secondary
objectives including PK and PD parameters, an evaluation of the
preliminary anticancer activity (efficacy) of PAS-004 and defining
the preliminary recommended Phase 2 dose(s).
About Pasithea Therapeutics
Corp.
Pasithea is a biotechnology company focused on
the discovery, research and development of innovative treatments
for central nervous system (CNS) disorders and RASopathies. With an
experienced team of experts in the fields of neuroscience,
translational medicine, and drug development, Pasithea is
developing new molecular entities for the treatment of neurological
disorders, including Neurofibromatosis type 1 (NF1), Solid Tumors,
and Amyotrophic Lateral Sclerosis (ALS).
Forward Looking Statements
This press release contains statements that
constitute “forward-looking statements” made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements include all statements,
other than statements of historical fact, regarding the Company’s
current views and assumptions with respect to future events
regarding its business, as well as other statements with respect to
the Company’s plans, assumptions, expectations, beliefs and
objectives, the success of the Company’s current and future
business strategies, product development, preclinical studies and
clinical trials, clinical and regulatory timelines, market
opportunity, competitive position, potential growth opportunities
and other statements that are predictive in nature. Forward-looking
statements are subject to numerous conditions, many of which are
beyond the control of the Company. While the Company believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to the Company on the date of this
release. These forward-looking statements are based upon current
estimates and assumptions and are subject to various risks and
uncertainties, including factors set forth in the Company’s most
recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q
and other filings made with the U.S. Securities and Exchange
Commission (SEC). Thus, actual results could be materially
different. The Company undertakes no obligation to update these
statements whether as a result of new information, future events or
otherwise, after the date of this release, except as required by
law.
Contact
Patrick GaynesCorporate Communicationspgaynes@pasithea.com
Pasithea Therapeutics (NASDAQ:KTTAW)
Graphique Historique de l'Action
De Juil 2024 à Août 2024
Pasithea Therapeutics (NASDAQ:KTTAW)
Graphique Historique de l'Action
De Août 2023 à Août 2024