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幹細胞驅動新藥 布利沙福(Burixafor)

開發階段

已完成美國IND一期臨床實驗及以自體造血幹細胞移植為適應症的二期臨床試驗(招收12個病人)規劃進行其他延伸性之相關臨床試驗。

已獲准在台灣及中國進行血癌病人化療增敏適應症之臨床試驗。


研發成果

1.已獲得21項專利權,專利行使範圍包括美國、歐亞、南非、新加坡以及菲律賓。堅強的結構式全球專利,可以保護到西元2028年

2.榮獲2008年國家新創獎-企業組/研發技術類

3.榮獲2008年中國化學學會技術獎章

4.獲科專補助1,834萬元進行臨床前開發計畫

5.獲科專補助2,097萬元進行一期臨床試驗

6.獲科專補助1,138萬元進行二期臨床試驗


業務發展

1.已完成美國IND一期臨床實驗及以自體造血幹細胞移植為適應症的二期臨床試驗,共招收12名病患;規劃進行其他延伸性之相關臨床試驗。

2.已獲准在台灣及中國進行血癌病人化療增敏適應症之臨床試驗。

3.洽談布利沙福歐、美、日地區對外授權。


Presentations

2009 ASH

TG-0054, a Novel and Potent Stem Cell Mobilizer, Displays Excellent PK/PD and Safety Profile in Phase I Trial David T Chung, Li-Wen Chang, Ying-Huey Huang, Cheng-Yuan Tsai, Ching-Hung Hsu, Chi-Hsin R. King, Judy H. Yuan, Chi-Feng Yen, Yu-Mai Chen, Yi Chin Lu and Ming-Chu Hsu

Rapid Mobilization of Murine Hematopoietic Stem and Progenitor Cells with TG-0054, a Novel CXCR4 Antagonist Ying-Huey Huang, Yi-Chun Liu, Chi-Feng Yen, Hua-Chien Chen, Shu-Jen Chen, Chi-Hsin R. King, and Ming-Chu Hsu


2013 ASH

Rapid Mobilization Of CD34+ Progenitor Cells With TG0054-03, a novelCXC Chemokine Receptor 4 (CXCR4) Antagonist Michael W. Schuster, Nabil Hagog, Bita Jalilizeinali, Sharon Funkhauser, Mary Sophy Yohannan, Jennifer Sadler, Sylvia Wood, Stacy Carey, Karen Kelleher, Chen-En Tsai, Ming-Chu Hsu, Li-Weng Chang and Zora Hsu


2015 ASH

A Phase II, Open-Label Pilot Study to Evaluate the Hematopoietic Stem Cell Mobilization of TG-0054 Combined with G-CSF in 12 Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Lymphoma - an Interim Analysis Gayatri Setia , Nabil Hagog , Bita Jalilizeinali, Sharon

Funkhouser, Loretta Pierzchanowski, Fengshuo Lan, Theodore G. Gabig, Bonnie Kiner-Strachan, Karen Kelleher , Ming-Chu Hsu, Li-Wen Chang and Michael W. Schuster.