Pasithea Therapeutics Announces Positive In Vivo Preclinical Efficacy Data for PAS-004 From NRAS Mutation Cancer Xenograft Models
Pasithea Therapeutics Announces Positive In Vivo Preclinical Efficacy Data for PAS-004 From NRAS Mutation Cancer Xenograft Models
-- Preclinical data continues to demonstrate PAS-004's potentially superior properties as compared to FDA approved MEK inhibitors --
— 临床前数据继续表明，与美国食品药品管理局批准的 MEK 抑制剂相比，PAS-004 具有潜在的优越特性 —
-- Once daily dose of PAS-004 delivers anti-tumor efficacy in in vivo NRAS mutation cancer models --
— 每日剂量的 PAS-004 一旦在体内 NRAS 突变癌症模型中发挥抗肿瘤功效 —
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.
加利福尼亚州南旧金山和迈阿密，2023 年 12 月 11 日（GLOBE NEWSWIRE）——专注于发现、研究和开发中枢神经系统（CNS）创新疗法的生物技术公司 Pasithea Therapeutics Corp.（纳斯达克股票代码：KTTA）（“Pasithea” 或 “公司”）今天宣布了两项评估 PAS-004 在 NNS 抗肿瘤疗效的体内研究的积极临床前结果 RAS 突变癌异种移植模型。
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.
在第一项研究中，PAS-004 在肺癌 NCI-H1299 细胞系衍生异种移植模型中表现出剂量依赖性的抗肿瘤功效。与车辆控制相比，剂量水平为 10 mg/kg 和 5 mg/kg 的 PAS-004 每天一次，可显著抑制肿瘤的生长。事实证明，当以同等剂量服用时，PAS-004 的抗肿瘤疗效优于比尼美替尼和塞卢美替尼。
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.
在第二项研究中，PAS-004 在肝癌 xHepG2 细胞系衍生异种移植模型中表现出剂量依赖性的抗肿瘤功效。与车辆控制相比，剂量水平为 10 mg/kg 和 5 mg/kg 的 PAS-004 每天一次，可产生显著的抗肿瘤活性。事实证明，当以同等剂量服用时，PAS-004 的抗肿瘤功效与比尼美替尼相似，优于塞鲁美替尼。
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.
开展这些研究是为了进一步支持 PAS-004，此前该公司计划在人体内首次进行开放标签剂量递增试验，该试验的对象是 MAPK 路径驱动的、包含 RAS、RAF 或 NF1 突变的晚期实体瘤患者或 BRAF/MEK 抑制失败的患者。I期研究预计最早将于2024年第一季度开始，此前该公司的研究性新药申请（IND）已被美国食品药品管理局接受。
"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.
Pasithea首席开发官Graeme Currie博士评论说：“PAS-004 凭借其大环化学结构，在几种临床前癌症、LMNA心肌病和1型神经纤维瘤病（NF1）模型中表现出最佳的药物样特性和体内剂量依赖性反应。”“持续抑制细胞外信号调节激酶（perK）对于提高癌症和其他 rasoPathies（例如1型神经纤维瘤病）的疗效是必要的。我们目前的模型表明，与现有的 MEK 抑制剂相比，我们在人体中的半衰期将更长，再加上我们的临床前特征，我们相信 PAS-004 的给药方案有可能实现每天一次或更少频率的给药方案，与现有疗法相比，我们希望这将提高依从性，并改善与其他癌症药物的组合性，” 柯里博士总结道。