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Pasithea Therapeutics Signs CMC Development And Manufacturing Agreement For The Production Of PAS-004
Pasithea Therapeutics Signs CMC Development And Manufacturing Agreement For The Production Of PAS-004
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 its contract with WuXi STA, a subsidiary of WuXi AppTec, to manufacture the active pharmaceutical ingredient ("API") for Pasithea's macrocyclic, next-generation MEK Inhibitor, PAS-004 (formerly CIP-137401).
After the completion of the pre-clinical testing and animal toxicology studies, GMP manufacturing is our final major requirement to support the Company's Investigational New Drug ("IND") application with the U.S. Federal Drug Association ("FDA"), which is expected in the second half of 2023.
WuXi STA is recognized as an industry leader in "end-to-end" chemistry, manufacturing, and controls (CMC) services, for both API and finished dosage forms, with extensive expertise and track record for meeting global quality standards.
"We are delighted to be working with WuXi STA, one of the largest and most well-respected Contract, Development, and Manufacturing Organizations (CDMOs) in the world. We remain on track with PAS-004 development and look forward to our IND submission followed by the initiation of our Phase 1 clinical trial," commented Pasithea CEO, Dr. Tiago Reis Marques.
"WuXi STA has a proven track record of manufacturing success to FDA standards and we believe that their high-quality capabilities will support progression of our drug candidate into the clinic. PAS-004 has already received orphan drug designation from the FDA for neurofibromatosis 1, and we plan to start our phase 1 clinical trial in the second half of 2023," stated Dr. Graeme Currie, Chief Development Officer of Pasithea.
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 its contract with WuXi STA, a subsidiary of WuXi AppTec, to manufacture the active pharmaceutical ingredient ("API") for Pasithea's macrocyclic, next-generation MEK Inhibitor, PAS-004 (formerly CIP-137401).
专注于发现、研究和开发中枢神经系统(CNS)疾病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”)今天宣布与药明康德的子公司无锡STA签订合同,为Pasithea的下一代大环MEK抑制剂生产活性药物成分(“API”),PAS-004(以前是 CIP-137401)。
After the completion of the pre-clinical testing and animal toxicology studies, GMP manufacturing is our final major requirement to support the Company's Investigational New Drug ("IND") application with the U.S. Federal Drug Association ("FDA"), which is expected in the second half of 2023.
完成临床前测试和动物毒理学研究后,GMP 生产是我们支持公司向美国联邦药品协会 (“FDA”) 申请的最终主要要求,该申请预计将于 2023 年下半年完成。
WuXi STA is recognized as an industry leader in "end-to-end" chemistry, manufacturing, and controls (CMC) services, for both API and finished dosage forms, with extensive expertise and track record for meeting global quality standards.
MaXi STA被公认为原料药和成品剂型 “端到端” 化学、制造和控制(CMC)服务的行业领导者,在满足全球质量标准方面拥有丰富的专业知识和往绩。
"We are delighted to be working with WuXi STA, one of the largest and most well-respected Contract, Development, and Manufacturing Organizations (CDMOs) in the world. We remain on track with PAS-004 development and look forward to our IND submission followed by the initiation of our Phase 1 clinical trial," commented Pasithea CEO, Dr. Tiago Reis Marques.
“我们很高兴能与世界上最大、最受尊敬的合同、开发和制造组织 (CDMO) 之一无锡STA合作。Pasithea 首席执行官 Tiago Reis Marques 博士评论道,我们仍步入正轨 PAS-004 的开发,并期待着我们的 IND 提交随后我们的 1 期临床试验的启动。
"WuXi STA has a proven track record of manufacturing success to FDA standards and we believe that their high-quality capabilities will support progression of our drug candidate into the clinic. PAS-004 has already received orphan drug designation from the FDA for neurofibromatosis 1, and we plan to start our phase 1 clinical trial in the second half of 2023," stated Dr. Graeme Currie, Chief Development Officer of Pasithea.
“paXi STA在成功生产符合美国食品药品管理局标准方面有着良好的记录,我们相信他们的高质量能力将支持我们的候选药物进入临床。PAS-004 已经获得美国食品药品管理局颁发的治疗1型神经纤维瘤病的孤儿药称号,我们计划在2023年下半年开始我们的1期临床试验。” Pasithea首席开发官Graeme Currie博士说。
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