초록

＋연구내용 및 결과
경구제의 개발은 임상 1상을 완료하고 이후 연구를 검토중이며, 적응증 확대를 위해 위암세포주에서 CKD-602와 반응관련 유전자 연구를 수행하였다. 소세포폐암에서 병용요법으로 임상 2상까지 완료하였고 주 1회 투여 요법의 임상 1상을 완료하였다. 각각의 임상 연구에 필요한 시험약의 원활한 공급과 합성 공정개선의 성과도 있었다.

Abstract ▼

I. The aim and necessity of the study
CKD research in stitute developed camptothecin anti-cancer drug CKD-602 with support from MIHWAF and cooperative research with the main hospitals in the country. CKD-602 has been sold in market since March 2nd , 2004 . In this study, the effect of injection m

I. The aim and necessity of the study
CKD research in stitute developed camptothecin anti-cancer drug CKD-602 with support from MIHWAF and cooperative research with the main hospitals in the country. CKD-602 has been sold in market since March 2nd , 2004 . In this study, the effect of injection mono- therapy and combination treatment of the drug on various tumor types have been clinically tested . After finalizing the clinical study, CKD-602 is expected to be released as an oral agent with extended applications on other tumor types.
II . Research accomplishment
1. Clinical research - Oral medication clinical study: In the schedule of Camtobell casule, which made the patients administered once a day for 7 days (total 7 time s) then had two weeks of rest period, the MTD was 19.6 mg/m2 (2.8 mg/m2/day X 7 times in 1 cycle). DLT was confirmed as the status of 3 grade diarrhea and ANC < 500 mm3 lasting over 4 days. In efficacy estimation, SD was confirmed in 10 subjects, and not confirmed in 2 subjects.
- Injection medication clinical study: Once a week administration direction phase 1 clinical study In weekly bolus sched ule which administered [Camtobell injection] total 3 times, the maximum tolerated doses(MTD) was determined as 9.75 mg/m2 (3 .25 mg/m2/day x 3 times, lcycle) and the maximum recommended doses(MRD) was determined as 9.0 mg/m2 (3.0 mg/m2/ day x 3 times, 1 cycle). Consequently, weekly bolus schedule is thought to be relatively safe to apply. Based on the determined MTD, RD in this study, further research which can confirm the effectiveness and safety by carrying out therapeutic search clinical study is anticipated.
: Phase 2 combin ation clinical study of Camtobell inj. with cisplatin in patients with small cell lung cancer
When intravenously administered for 4 days (30 min, 21-day cyc le) with cisplatin (60 mg/m2/day) into patients with progressive-disease small cell lung cancer, Catobel l inj . showed 70% response ratio. And there was no significant adverse drug response except hematological adverse response which was reversible and controlable.
2. Clinical sample supply and process improvement
2-1. Production of clinical sample
2-1-1 . Sample synthesis part
Sample synthesis was completed in BGMP in order to supply clinical test sample of oral and combination direction.
2-1-2 . Process improvement research
A. Synthesis yield improvement study of CKD-602 : From (S)-Camptothecin as an initial material, CKD-602 was synthesized by methylation and Mannich reaction. Consequently, reaction yield of two process was 30% in creased in average(17.8 % -> 23.1 %) , and cost(6,OOO,OOO won) and production time were saved by synthesis process improvement reducing impurities.
B. CKD- 602 table timprovement study: There has been effort to develop purification method using open silica column which is more easy to scale up. And , through basic research, purification method composed of open column separation and slurry purification phase was established.
2-2. Total synthesis process improvement of CKD- 602
- Total synthesis of CKD- 602 is possible through total 19 phase. In this study, there was effort to improve it economically. However, there was no remarkable result.
- There was no remarkable improvement and good result to be commercialized.
3. CKD-602 gene search
- CKD-602 response related gene search
Among the transcriptome of CKD- 602 sensitive stomach cancer cell line, DNA replication or DNA repair related gene expression was significantly different from other stomach cancer cell line.
- CKD- 602 drug target search study
III. Application plan of research development result
Enlargement of application area, improvement of cure ratio by combination therapy study of CKD-602 with previous anti-cancer drug would make the sales increase anticipated. By the development of oral medication development. medication adaptable to CKD- 602's therapeutic mechanism would be established.

목차 Contents

• 표지 ... 1
• 제출문 ... 2
• 목차 ... 3
• 보고서 요약서 ... 4
• 요약문 ... 5
• SUMMARY ... 7
• 연구 성과 실적 및 향후 계획 ... 9
• 총괄연구개발과제의 연구성과 실적 및 향후 계획 ... 9
• 연구성과유형별 세부 내역 ... 10
• 참여연구원 현황표 ... 17
• II. 총괄연구과제 연구결과 ... 19
• 1. 연구개발과제의 배경 및 필요성 ... 20
• 2. 국내외 기술개발 현황 ... 21
• 3. 연구개발과제의 추진체계 ... 25
• 4. 연구개발수행 내용 및 결과 ... 25
• 5. 목표달성도 및 관련분야 기여도 ... 37
• 6. 향후 연구 성과 추진 계획 ... 38
• 7. 연구개발결과의 파급효과 ... 38
• 8. 연구개발결과의 활용계획 ... 40
• 9. 연구개발과정에서 수집한 해외과학기술정보 ... 41
• 10. 참고문헌 ... 42
• III. 첨부서류 ... 43
• 끝페이지 ... 46