-- Preclinical data continues to demonstrate PAS-004's potentially superior properties as compared to FDA approved MEK inhibitors --
-- Once daily dose of PAS-004 delivers anti-tumor efficacy in in vivo NRAS mutation cancer models --
SOUTH SAN FRANCISCO, Calif. and MIAMI, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced positive preclinical results from two in vivo studies evaluating the anti-tumor efficacy of PAS-004 in NRAS mutation cancer xenograft models.
In the first study, PAS-004 exhibited dose-dependent anti-tumor efficacy in the lung cancer NCI-H1299 cell-line-derived xenograft model. PAS-004 at dose levels of 10 mg/kg and 5 mg/kg, once daily, significantly inhibited tumor growth as compared to vehicle control. The anti-tumor efficacy of PAS-004, when taken at equivalent doses was shown to be superior to that of binimetinib and selumetinib.
In the second study, PAS-004 exhibited dose-dependent anti-tumor efficacy in the liver cancer xHepG2 cell-line-derived xenograft model. PAS-004 at dose levels of 10 mg/kg and 5 mg/kg, once daily, produced signigicant antitumor activities as compared to vehicle control. The anti-tumor efficacy of PAS-004, when taken at equivalent doses was shown to be similar to that of binimetinib and superior to that of selumetinib.
These studies were conducted to provide further support of PAS-004 ahead of the Company's planned first-in-human Phase 1 open-label dose escalation trial in patients with MAPK pathway-driven advanced solid tumors harboring RAS, RAF or NF1 mutations or patients who have failed BRAF/MEK inhibition. The Phase I study is expected to start as early as the first quarter of 2024, following acceptance of the Company's Investigational New Drug Application (IND) with the FDA.
"PAS-004, with its macrocyclic chemical structure, has demonstrated optimal drug like properties and dose-dependent response in vivo across several preclinical cancer, LMNA cardiomyopathy and neurofibromatosis type 1 (NF1) models," commented Dr. Graeme Currie, Chief Development Officer of Pasithea. "Sustained suppression of extracellular signal-regulated kinases (pERK) is necessary to drive efficacy in both cancer and other RASopathies, such as NF1. Our current modeling suggests we will have a longer half-life in humans than existing MEK inhibitors and when coupled with our preclinical profile, we believe a once-a-day or less frequent dosing regimen is likely to be achieved for PAS-004, which we hope will lead to improved compliance when compared to existing therapies, as well as better combinability with other cancer agents," concluded Dr. Currie.