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 --
— 臨床前數據繼續表明，與美國食品藥品管理局批准的 MEK 抑制劑相比，PAS-004 具有潛在的優越特性 —
-- Once daily dose of PAS-004 delivers anti-tumor efficacy in in vivo NRAS mutation cancer models --
— 每日劑量的 PAS-004 一旦在體內 NRAS 突變癌症模型中發揮抗腫瘤功效 —
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.
加利福尼亞州南舊金山和邁阿密，2023 年 12 月 11 日（GLOBE NEWSWIRE）——專注於發現、研究和開發中樞神經系統（CNS）創新療法的生物技術公司 Pasithea Therapeutics Corp.（納斯達克股票代碼：KTTA）（“Pasithea” 或 “公司”）今天宣佈了兩項評估 PAS-004 在 NNS 抗腫瘤療效的體內研究的積極臨床前結果 RAS 突變癌異種移植模型。
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.
在第一項研究中，PAS-004 在肺癌 NCI-H1299 細胞系衍生異種移植模型中表現出劑量依賴性的抗腫瘤功效。與車輛控制相比，劑量水平爲 10 mg/kg 和 5 mg/kg 的 PAS-004 每天一次，可顯著抑制腫瘤的生長。事實證明，當以同等劑量服用時，PAS-004 的抗腫瘤療效優於比尼美替尼和塞盧美替尼。
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.
在第二項研究中，PAS-004 在肝癌 xHepG2 細胞系衍生異種移植模型中表現出劑量依賴性的抗腫瘤功效。與車輛控制相比，劑量水平爲 10 mg/kg 和 5 mg/kg 的 PAS-004 每天一次，可產生顯著的抗腫瘤活性。事實證明，當以同等劑量服用時，PAS-004 的抗腫瘤功效與比尼美替尼相似，優於塞魯美替尼。
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.
開展這些研究是爲了進一步支持 PAS-004，此前該公司計劃在人體內首次進行開放標籤劑量遞增試驗，該試驗的對象是 MAPK 路徑驅動的、包含 RAS、RAF 或 NF1 突變的晚期實體瘤患者或 BRAF/MEK 抑制失敗的患者。I期研究預計最早將於2024年第一季度開始，此前該公司的研究性新藥申請（IND）已被美國食品藥品管理局接受。
"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首席開發官Graeme Currie博士評論說：“PAS-004 憑藉其大環化學結構，在幾種臨床前癌症、LMNA心肌病和1型神經纖維瘤病（NF1）模型中表現出最佳的藥物樣特性和體內劑量依賴性反應。”“持續抑制細胞外信號調節激酶（perK）對於提高癌症和其他 rasoPathies（例如1型神經纖維瘤病）的療效是必要的。我們目前的模型表明，與現有的 MEK 抑制劑相比，我們在人體中的半衰期將更長，再加上我們的臨床前特徵，我們相信 PAS-004 的給藥方案有可能實現每天一次或更少頻率的給藥方案，與現有療法相比，我們希望這將提高依從性，並改善與其他癌症藥物的組合性，” 柯里博士總結道。