Pasithea Therapeutics Corp (KTTA), a clinical-stage biotechnology company, on Tuesday, announced the opening of three new clinical trial sites in Eastern Europe, say Romania and Bulgaria, for its ongoing Phase 1 trial of PAS-004. PAS-004, a next-generation macrocyclic MEK inhibitor, is being developed for the treatment of patients with neurofibromatosis type 1 or NF1 and other cancer indications.
In Eastern Europe, the company is partnering with Arensia Exploratory Medicine, Institute of Oncology Bucharest, Arensia Exploratory Medicine, Institute of Oncology Cluj-Napoca, and Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia- EOOD.
Pasithea has also completed the initial dosing of three patients in Cohort 4A or 15mg capsule and is progressing with patient recruitment for Cohort 4B or 4mg tablet.
Interim safety and pharmacokinetic or PK data from these cohorts are expected in Q1 2025.
The Phase 1 study is designed to evaluate the safety, tolerability, and preliminary efficacy of PAS-004 in patients with MAPK pathway-driven advanced solid tumors and mutations in RAS, NF1, or RAF, or those who have failed prior treatments with BRAF/MEK inhibitors.
Dr. Tiago Reis Marques, CEO of Pasithea, stated, "We are excited to expand our clinical trial into Eastern Europe and continue advancing PAS-004. The addition of these sites enhances our ability to test PAS-004 in a broader patient population, particularly those with tumors that are more sensitive to single-agent MEK treatment or who have failed previous therapies."
The company had cash, cash equivalents, and marketable securities of $9.4 million as of September 30, 2024.
KTTA closed Monday's (Jan. 13, 2025) trading at $2.62. In premarket trading, the stock is down 16.4% at $ 2.18.
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