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[KSMRM 학회 공식 파트너사 소개] 미토이뮨 신약 'MIT-001', 美 FTA, IND 승인
작성일 2021-04-08조회수 465



안녕하십니까 대한미토콘드리아 연구의학회 회원 여러분,


대한미토콘드리아 연구의학회 공식 파트너사 미토이뮨의 소식을 전합니다.


미토이뮨사의 신약 'MIT-001', FDA IND 승인


SEOUL, South KoreaApril 6, 2021 /PRNewswire/ -- MitoImmune Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for MIT-001, an innovative new drug candidate for the treatment of oral mucositis.


중략


In addition to phase 2 clinical trial for the patients with HNSCC in the United States and Korea, Mitoimune has recently received the IND approval from the Ministry of Food and Drug Safety (MFDS) in Korea for a phase 2 clinical trial, to verify the safety and efficacy for OM in the lymphoma/ multiple myeloma patients with chemotherapy (CT) undergoing hematopoietic stem cell transplantation (HSCT). The first HSCT patient administration is planned for the 2nd quarter of this year.


자세한 소식은 아래의 링크를 참조 부탁드립니다.


https://www.prnewswire.com/news-releases/mitoimmune-received-fda-clearance-of-ind-application-for-mit-001-a-novel-anti-inflammatoryanti-necrotic-therapy-for-oral-mucositis-in-ccrt-patients-with-head-and-neck-cancer-301262718.html


대한미토콘드리아연구의학회 사무국 드림.



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