Pasithea Therapeutics opens enrollment in the U.S. for Phase 1 trial of PAS-004

Pasithea Therapeutics announced the activation of four clinical trial sites in the United States. These U.S. clinical trial sites in Texas and Virginia are now open and actively enrolling patients. This announcement follows the approval from the U.S. Food and Drug Administration of the Investigational New Drug application for PAS-004, and FDA review of the protocol for the Company’s Phase 1 multicenter, open-label trial 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 objective of the Phase 1 study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of PAS-004 as well as to evaluate the preliminary anticancer activity of PAS-004 and to define the preliminary recommended Phase 2 dose. The Company’s clinical development plan for PAS-004 following the Phase 1 study is to begin a Phase 2 clinical trial in NF1 pediatric and adult patients as soon as safety and PK are established. Pasithea has selected Novotech as the clinical research organization for the Phase 1 trial and will be collaborating in the U.S. with NEXT Oncology, led by Dr. Anthony Tolcher M.D., along with Dr. Ildefonso Rodriguez M.D., acting as principal investigator for the San Antonio, TX site. There are also three other clinical trial sites in Eastern Europe that are expected to open in the coming months.