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SC-01

產品簡介

癌症在世界各先進國家的十大死因皆名列前茅,而對癌症的治療方針主要為早期診斷早期治療。目前癌症的篩檢及診斷主要仰賴以下幾種方式:電腦斷層(CT)、核磁共振(MRI)、正子斷層攝影(PET)、單光子正子攝影術合併電腦斷層(SPECT/CT)、X光攝影、超音波檢查、血液特定抗原檢查(carcinogen specific antigen)等各種檢查。許多檢查都有實際使用的限制,也造就各種檢查都有其不可取代性。臨床醫師考量準確性與價格因素下,可能需同時使用兩種以上的檢查作為輔助工具,所以各項檢查工具彼此間保持既競爭又合作的關係。SC-01是一種特定胜肽與聚醣類化合物的結合生物分子,胜肽與醣類均能夠螯合放射性核種鎝(Tc99m)的金屬離子,且於生物體內的安全性高,可自然降解及排除,副作用低。SC-01此產品結合鎝(Tc99m)開發應用於SPECT/CT檢測儀器的核子醫學癌症診斷用藥,不僅具有做為藥物載體發展的潛力,也可透過與鎝放射離子的結合,在腫瘤組織中顯像,做為核子醫學藥物在癌症領域的診斷用藥。

臨床發展

利用SC-01藥物結合鎝(Tc99m)開發應用於SPECT/CT檢測儀器的核子醫學癌症診斷用藥,第一階段將先以乳癌為主要適應症,現已完成許多乳癌藥物發展模式的測試,包括細胞試驗與動物試驗,目前已確認SC-01的安全性高,且於齧齒類動物模式中可以達到預期中乳癌顯像之檢測效果。聚天生醫目前同步進行臨床藥物開發與各項適應症的基礎研究,以測試SC-01在不同癌症的診斷功效。未來可透過結合放射治療的元素來做為患者體內放射線治療的用途、並透過這些數據作為發展藥物高分子載體的基礎,提供藥物載體開發專案中許多關於化療藥物利用SC-01載體技術於癌症組織藥物蓄積的可行性資料。SC-01的胜肽可以讓腫瘤組織主動攝入,並同步將放射線物質帶入細胞內,提供較PET攝影術更低價、且清楚的核醫影像診斷工具。目前本臨床試驗已於美國收案兩位乳癌受試者,預計將於2017年中完成一期收案以確認GP藥物的多種劑量安全性,及進行初步核子醫學癌症影像之評估。

相關學術資料

PUBLISHED ARTICLES IN REFERRED JOURNALS

  1. Wei I-Chien, Tsao Ning, Huang Y-H, Ho Y-S, Wu C-C, Yu D-F, Yang DJ. 99mTc-glycopeptide: synthesis, biodistribution and imaging in breast tumor-bearing rodents. Applied Radioan and Isotopes 2008; 66:320-331.
  2. Tsao Ning, Wang CH, Her LJ, Tzen KY, Chen JY, Yu DF, and Yang DJ. Development of 68Ga-Glycopeptide as an imaging probe for tumor angiogenesis. Journal of Biomedical and Biotechnology. 2011: 267206

ABSTRACTS

  1. Wei I-C, Tsao Ning, Huang YH, Huang CC, Yang DJ. Ho Y-S, Chanda M, Wu CC, Kurihara H, Kohanim S, Oh C-S, Kim EE. Development of GP as a cell penetrating carrier for cancer therapy. 2007 Annual Meeting of the AAPS in San Diego, CA (Nov 11-15, 2007) Pharm Res 2007 (Abstract 1082).
  2. Tsao Ning, Wei I-C, Huang YH, Yang DJ. Ho Y-S, Wu CC, Oh C-S, Kurihara H, Kohanim S, Yu D-F, Kim EE. Safety, biodistribution, dosimetry and breast tumor imaging potential of Tc-99m-glycopeptide. 2007 Annual Meeting of the AAPS in San Diego, CA (Nov 11-15, 2007) Pharm Res 2007 (Abstract 1084).
  3. Huang YH, Wei I-C, Tsao Ning, Yang DJ. Ho Y-S, Oh C-S, Wu CC, Kurihara H, Kohanim S, Yu D-F, Kim EE. Targeting tumor angiogenesis using glutamate transporter-based glycopeptide 2007 Annual Meeting of the AAPS in San Diego, CA (Nov 11-15, 2007) Pharm Res 2007 (Abstract 1085).
  4. Tsao Ning, Wei I-C, Huang YH, Yang DJ, Ho Y-S, Wu CC, Oh C-S, Kurihara H, Kohanim S, Yu D-F, Kim EE. Glycopeptide: tissue distribution and efficacy assessment of antiangiogenic therapy. 2007 Annual Meeting of the AAPS in San Diego, CA (Nov 11-15, 2007) Pharm Res 2007 (Abstract 1083).
  5. Tsao Ning, Yang DJ, Wei I-C, Huang Y-H, Huang C-C, Chanda M, Kurihara H, Kohanim S, Oh C-S, Kim EE. Biodistribution and imaging of Ga-68 and Tc-99m-glycopeptide-methotrexate (GP-MTX) in rodents. 55th Annual Meeting of the Society of Nuclear Medicine. New Orleans, LA, June 14-18, 2008. J Nucl Med 2008; 49(Supp.1):331P. (abstract 1402).
  6. Tsao Ning, Oh C, Kohanim S, Yu D-F, Chanda M, Tzen K, Yang DJ. Synthesis of 68Ga-Glycopeptide as an imagng probe for tumor angiogenesis. 2010 Annual Meeting of the AAPS in New Orleans, LA, November 13-18, 2010. Pharm Res 2010 (Abstract SA 8205).
  7. Tsao Ning, Yu DF, Yang DJ. Glutamate transporter as a target for image-guided therapy in breast cancer. 59th Annual Meeting of the Society of Nuclear Medicine. Miami, Florida, June 9-13, 2012. J Nucl Med 2012 (Oral presentation, Abstract 06).
  8. Tsao Ning, Yu DF, Yang DJ. Glycopeptide as a Tool for Tumor Theranostic Applications. 2012 Annual Meeting of the AAPS in Chicago, IL, October 14-18, 2012. Pharm Res 2012 (Abstract AM-12-00872).