亞獅康膽道癌試驗完成收案 臨床數據下半年出爐 The Central News Agency 中央通訊社 2019年1月2日（中央社記者韓婷婷台北2日電）生物製藥公司亞獅康-KY宣布全球二線膽道癌安慰劑對照臨床試驗TreeTopp受試者完成收案，超前預定進度，初步臨床數據預計於2019年下半年出爐。亞獅康-KY表示，TreeTopp試驗是一項隨機、雙盲、安慰劑對照的二線膽道癌臨床試驗。膽道癌在亞洲每年影響逾20萬人，目前尚未有核准的標靶療法可以治療此疾病。亞獅康-KY表示，該項試驗自全球56處臨床試驗中心招收127位接受過第一線治療但疾病仍惡化的病患，試驗地點包括美國、歐洲、澳洲、日本、韓國與亞太地區。這項試驗的共同主要評估指標為客觀反應率與無惡化存活期。若本試驗結果為正面，亞獅康-KY擬向美國食品暨藥物管理局(FDA) 申請以加速核准方式進行varlitinib於二線膽道癌的藥證申請。（編輯：楊玫寧）1080102
ASLAN Pharmaceuticals Completes Enrolment for Global Pivotal TreeTopp Study Ahead of Schedule By GlobeNewswire, January 02, 2019, Topline data from largest global, placebo-controlled study in second line biliary tract cancer expected in the second half of 2019 SINGAPORE, Jan. 02, 2019 (GLOBE NEWSWIRE)--ASLAN Pharmaceuticals (NASDAQ:ASLN, TPEx:6497), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, today announced the completion of patient enrolment in TreeTopp (TREatmEnT OPPortunity), a global pivotal study investigating varlitinib in second-line biliary tract cancer (BTC). Topline data is expected in the second half of 2019. TreeTopp is a randomised, double-blind, placebo-controlled clinical trial in second-line BTC comparing varlitinib and capecitabine to placebo and capecitabine. It is the largest global, placebo-controlled study in BTC conducted to date. Currently, there are no approved targeted therapies for the treatment of BTC which affects more than 200,000 people in Asia every year. The study recruited 127 patients who have failed first line therapy from 56 sites worldwide including the US, Europe, Australia, Japan, Korea and other Asia Pacific countries. The co-primary endpoints of the study are objective response rate and progression free survival. The trial will meet its primary objective if either endpoint is significant at the one-sided 5% level or if both endpoints are significant at the one-sided 10% significance level. If the study results are positive, ASLAN intends to submit a New Drug Application to the US Food and Drug Administration (FDA) for an accelerated approval in second-line BTC. Dr Mark McHale, Chief Operating Officer of ASLAN Pharmaceuticals, said: "TreeTopp has generated strong levels of interest from the international oncology community, which enabled us to recruit patients into the study ahead of our timeline and demonstrates the clear need for a new therapy to treat BTC, a cancer that is often diagnosed at an advanced stage with limited treatment options and poor survival rates." Varlitinib is a potent, reversible, small molecule pan-HER inhibitor currently in development across multiple indications including biliary tract, gastric, metastatic breast and metastatic colorectal cancers. It has previously demonstrated tumour shrinkage responses and durable disease stabilization in BTC patients in a phase 1b study and has obtained Orphan Drug Designation (ODD) from the US FDA for BTC and the Ministry of Food and Drug Safety in South Korea. ASLAN will present new safety and efficacy data from its ongoing multicentre phase 1b/2 study of varlitinib plus gemcitabine and cisplatin in first line BTC at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium on Friday, 18 January 2019 in San Francisco. Data from a pooled analysis of three phase 1 studies of varlitinib in combination with platinum-based regimens in BTC will also be presented at the same conference.
Varlitinib (ASLAN001) is a highly potent, oral, reversible, small molecule pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. These receptors can be mutated or overexpressed in many tumors, which can cause excessive proliferative activity and uncontrolled growth. Therefore, by inhibiting the activation of the HER receptors, varlitinib could inhibit proliferation and control tumor growth. Varlitinib is currently being studied in gastric, biliary tract, breast and colorectal cancers. Varlitinib has been granted orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer, and was awarded orphan drug designation for the treatment of biliary tract cancer by the Ministry of Food and Drug Safety in South Korea.
About ASLAN Pharmaceuticals ASLAN Pharmaceuticals (ASLAN, 6497.TT, Nasdaq:ASLN) is a clinical-stage oncology-focused biopharmaceutical company developing novel therapeutics for global markets. ASLAN targets diseases that are both highly prevalent in Asia and orphan indications in the United States and Europe. Led by a senior management team with extensive experience in global and regional development and commercialization, ASLAN is headquartered in Singapore and has offices in Taiwan and China. ASLAN's portfolio is comprised of four product candidates which target validated growth pathways applied to new patient segments, novel immune checkpoints and novel cancer metabolic pathways. ASLAN's partners include Array BioPharma, Bristol-Myers Squibb, Almirall and CSL. For additional information please visit www.aslanpharma.com.
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