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종근당, 대장암 대상 CKD-516 "국내 임상3상 승인" - 바이오스펙테이터

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종근당, 대장암 대상 CKD-516 "국내 임상3상 승인"

입력 2019-10-07 09:39 수정 2019-10-07 09:39

바이오스펙테이터 김성민 기자

진행성/전이성 대장암 환자 248명 대상 CKD-516+이리노테칸 병용요법과 스티바가 단독요법의 유효성, 안전성 비교

종근당이 대장암 치료제 후보물질인 CKD-516의 국내 임상3상을 시작할 예정이다.

식품의약품안전처는 대장암 환자에게 CKD-516와 이리노테칸(irinotecan)을 병용투여와 스티바가(regorafenib) 단독요법의 유효성과 안전성을 비교평가하기 위한 다기관, 무작위배정 임상3상을 지난 2일 승인했다.

이번 임상은 이전 치료받은 진행성 또는 전이성 대장암(또는 결직장암) 환자 248명을 대상으로 연세대학교의과대학 세브란스병원에서 진행하게 된다.

CKD-516은 미세소관 중합반응(microtubule polymerization)을 억제하는 약물로, 종양혈관을 선택적으로 타깃하는 경구형 혈관 저해제(vascular disrupting agent, VDA)다. CKD-516은 종양혈관의 비성숙한(immature) 혈관내피세포에 작용해 모양이 변하면서 혈액이 흐르지 못하고 닫히는 것을 조직상에서 확인한 바 있다. 반면 정상 혈관내세포는 구조상 약물의 영향을 받지 않는다는 설명이다.

종근당은 대장암 환자에게 CKD-516과 이리노테칸(irinotecan)을 병용투여 임상1/2상을 진행한 바 있다(NCT03076957). 이리노테칸은 5일 경구 복용한(5, 10, 20, 25mg/일) 다음 2일 쉬는 프로토콜 투여했다.

종근당은 올해 CKD-516과 PD-1 항체 병용투여 임상도 계획하고 있다. 종근당은 지난 4월 열린 미국암학회(AACR) 2019에서 CKD-516와 면역항암제를 병용투여하는 메커니즘과 전임상 데이터를 발표한 바 있다.

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