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바이젠셀, 'NK/T세포 림프종 치료제' 희귀약 지정 - 바이오스펙테이터

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바이젠셀, 'NK/T세포 림프종 치료제' 희귀약 지정

입력 2019-11-04 09:52 수정 2019-11-04 09:52

바이오스펙테이터 장종원 기자

식약처 '개발단계 희귀의약품' 대상 선정..2상 종료 후 신속 허가신청 가능

보령제약 관계사 바이젠셀이 개발 중인 면역항암제 엡스타인 바 바이러스(Epstein Barr-virus, EBV) 특이적인 세포독성 T세포(Cytotoxic T lymphocytes, CTLs) 'VT-EBV-N'가 식품의약품안전처 개발단계 희귀의약품으로 지정됐다고 4일 밝혔다.

이번 개발단계 희귀의약품 지정으로 바이젠셀은 현재 진행중인 'VT-EBV-201’의 임상 2상이 끝나는 대로 신속 허가신청을 할 수 있게 됐다.

'VT-EBV-201'은 희귀 난치성 질환이자 혈액암의 일종인 EBV양성 NK/T세포 림프종 환자 중 관해 후 재발 고위험군 환자를 대상으로 완전 치유를 목적으로 미세잔존암을 제거하기 위한 치료제로 개발되고 있으며, 2017년 임상시험계획(IND)을 승인 받고 현재 임상 2상이 진행 중이다.

'VT-EBV-201’는 연구자주도임상 결과가 국제학술지에 소개되면서 주목을 받은 바 있다. 2015년 5월 미국 유전자세포치료학회 공식저널 몰레큘러 테라피(Molecular Therapy)지에 발표한 논문에 따르면, 항암치료 및 자가이식을 받은 NK/T세포 림프종 환자 11명에게 'VT-EBV-201를 투여한 결과 11명의 환자가 모두 생존해 전체 생존율 100%, 5년 무병 생존률이 90 %에 달하는 것으로 나타났다. 이는 모든 환자를 5년 이상 장기추적조사(long-term follow up)한 결과다.

일반적으로 EBV는 동양인의 경우, 인구의 약 90%가 감염돼 있으며, 정상인에서는 암을 유발하지 않지만 면역체계가 손상되어 있을 경우 잠복하던 바이러스가 활성화해 암을 유발한다. EBV와 같은 바이러스에 감염된 종양세포의 완전사멸을 위해서는 CTLs 반응이 필수적이다.

EBV 연관 종양인 NK/T세포 림프종은 한국인 비호지킨 림프종의 약 6.3 %에 해당하며 아시아권에서 많이 발생하는 질병으로 완치 후 2년 이내 재발율이 75 %에 이르고 재발 이후에는 별다른 치료법이 없어 상당수가 사망하는 예후가 좋지 않은 질병이다.

바이젠셀 관계자는 "VT-EBV-201이 상용화될 경우, 재발 가능성이 높은 환자에게 치료의 기회를 제공할 뿐 아니라, 더 나아가 완치까지 가능 할 수 있을 것으로 기대된다"고 말했다.

바이젠셀은 'VT-EBV-201' 다음 파이프라인으로 급성골수성백혈병 치료제 'VT-Tri-A'를 준비하고 있으며, 연내 식약처에 임상시험계획(IND)을 승인받고 상업화 임상에 진입하는 것을 목표로 하고 있다.

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