F*太景布利沙福再添新適應症，化療增敏臨床將收案 MoneyDJ新聞 2015-04-30 10:22:45 記者 新聞中心 報導 F*太景(4157)今(30)日表示，公司自主研發之幹細胞驅動劑布利沙福，將在自體與異體幹細胞移植之外，再開發化療增敏之新適應症(chemosentization)；將與位於大陸天津的中國醫學科學院血液病醫院合作，招募罹患難治或復發急性骨髓性白血病的病患，測試布利沙福是否能增進化療效果。F*太景表示，該院人體試驗委員會已核准此試驗，即將開始收案。F*太景指出，目前對罹患急性骨髓性白血病病患的治療是以化療藥物為主，但若是「復發或難治型」，目前仍無真正有效的治療，原因在於化療藥物對於躲藏在骨髓中的血液腫瘤細胞的毒殺效果有限，這是導致疾病復發或難治的重要原因，也是醫界急需突破的課題。因此，與天津血液病醫院合作的臨床試驗，將針對罹患「復發或難治型急性骨髓性白血病」之病患，在既有的化療之上加上布利沙福進行治療，測試其安全性以及能否達到「化療增敏」的效果。F*太景表示，布利沙福能與CXCR4結合，阻斷SDF-1/CXCR4軸參與的生理和病理過程。據研究，CXCR4/SDF-1軸可促進白血病細胞存活、增殖、轉移及耐藥，也與白血病骨髓內外復發關係密切。且布利沙福在急性骨髓性白血病的小鼠模型，已證實能將躲藏在骨髓中的白血病細胞動員到周邊血而增加化療藥物的毒殺效果，進而顯著延長小鼠的存活時間，因此布利沙福能開發白血病的化療增敏作用。此一化療增敏之臨床試驗將評估布利沙福合併化療藥物「cytarabine」及「fludarabine」，治療「復發或難治型急性骨髓性白血病」的安全性及療效。F*太景說明，首先將評估化療藥物合併布利沙福治療此類病人的最大耐受劑量 (MTD)，接著，將以此最大耐受劑量，進行第二期臨床試驗，以進一步評估布利沙福合併cytarabine及fludarabine，治療這類病人所能達到的緩解率、無疾病存活期及整體存活期，以及安全性；若試驗效果良好，太景將進行後期臨床試驗，以取得此適應症的上市許可。F*太景指出，布利沙福為具有多種潛在適應症的小分子化合物，除了化療增敏以外，布利沙福開發中的適應症包括自體幹細胞植與異體幹細胞移植，仍待開發的則有治療組織缺血性相關疾病（例如心肌梗塞）之潛力。在自體幹細胞移植部分，布利沙福的安全性與幹細胞驅動效果相當突出。根據太景美國血液醫學年會(ASH)發表的Phase I針對健康受試者與Phase IIa臨床試驗針對多發性骨髓瘤、霍奇金病及非霍奇金淋巴瘤病人的病患的臨床數據顯示其安全性與幹細胞動員效果優異。此外，在異體幹細胞移植上，F*太景表示，與德國Cellex簽署協議，將在德國德勒斯登大學附屬醫院，最多招募37位無法以G-CSF成功驅動出足夠幹細胞的捐贈者，測試布利沙福是否可以從異體造血幹細胞自願捐贈者身上驅動出足以進行移植的幹細胞。另與台大醫學院合作的迷你豬動物模型研究也發現，布利沙福具有治療組織缺血性相關疾病（例如心肌梗塞）之潛力，這也是未來太景考慮拓展之適應症。
TaiGen begins Phase I/II trial of burixafor in China to treat acute myeloid leukemia PBR Staff Writer Published 01 May 2015 TaiGen Biotechnology Company has started a Phase I/II trial of burixafor in combination with two chemotherapeutic agents fludarabine and cytarabine in adults with relapsed or refractory acute myeloid leukemia (AML) in China. Burixafor (TG-0054) is a new, potent and selective chemokine receptor antagonist discovered by TaiGen. Around 15 patients will be enrolled in this open-label trial, which is designed to determine the safety and efficacy of burixafor plus fludarabine and cytarabine. The trial will evaluate maximum tolerated dose of burixafor, as well as other efficacy endpoints such as complete response, disease free survival and overall survival. Institute of Hematology and Blood Diseases Hospital hematologist/oncologist professor Wang JianXiang will lead the trial under a clinical trial authorization for Class 1.1 new drug from China FDA. TaiGen chairman and CEO Dr Ming-Chu Hsu said: "Chemotherapy and stem cell transplantation are the mainstay of leukemia treatment. We know from our clinical study to date, burixafor can mobilized sufficient stem cells necessary for hematopoietic stem cell transplantation. "This study will give us the additional information on the utility of burixafor as a chemosensitizer in combination with chemotherapy and could greatly expand the indications and increase the market potential in hematology/oncology." The company said that burixafor have already completed one Phase I and one Phase II trial in the US, with another Phase II trial in autologous stem cell transplantation is ongoing in the country.
ScinoPharm to Provide Active Pharmaceutical Ingredient to TaiGen for Novel Stem Cell Drug ScinoPharm Taiwan, Ltd. (TWSE: 1789) specializing in the development and manufacture of active pharmaceutical ingredients, and TaiGen Biotechnology (4157.TW; F*TaiGen) jointly announced today the signing of a manufacturing contract for the clinical supply of the API of Burixafor, a new chemical entity discovered and developed by TaiGen. The API will be manufactured in ScinoPharm's plant in Changshu, China. This cooperation not only demonstrates Taiwan's international competitive strength in new drug development, but also sees the beginning of a domestic pharmaceutical specialization and cooperation mechanisms, thus establishing a groundbreaking milestone for Taiwan's pharmaceutical industry. Dr. Jo Shen, President and CEO of ScinoPharm said, "This cooperation with TaiGen is of representative significance in the domestic pharmaceutical companies' upstream and downstream cooperation and self-development of new drugs, and indicates the Taiwanese pharmaceutical industry's cumulative research and development momentum is paving the way forward". Dr. Jo Shen emphasized, "ScinoPharm's Changshu Plant provides high-quality API R&D and manufacturing services through its fast, flexible, reliable competitive advantages, effectively assisting clients of new drugs in gaining entry into China, Europe, the United States, and other international markets." According to Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen, "R&D is the foundation of the pharmaceutical industry. Once a drug is successfully developed, players at all levels of the value chain could reap the benefit. Burixafor is a 100% in-house developed product that can be used in the treatment of various intractable diseases. The cooperation between TaiGen and ScinoPharm will not only be a win-win for both sides, but will also provide high-quality novel dug for patients from around the world."
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