Tivantinib全球第三期临床试验登记第一个肝癌病人

StephenW

http://pharmalive.com/news/index.cfm?articleID=876513&categoryid=9&newsletter=1
Daiichi Sankyo and ArQule Enroll First Hepatocellular Carcinoma Patient into Global Phase 3 Trial for Tivantinib
        Tivantinib全球第三期临床试验登记第一个肝癌病人
                        

   
   
                                        
TOKYO & WOBURN, Mass.--(BUSINESS WIRE)--Jan 31, 2013 - Daiichi Sankyo Company, Limited (TSE 4568) and ArQule, Inc. (Nasdaq: ARQL) today announced that the first patient has been enrolled in the pivotal Phase 3 METIV-HCC (MET-high patients with tivantinib in HCC) trial of tivantinib (ARQ 197). Tivantinib, an investigational selective inhibitor of MET, a receptor tyrosine kinase, is being evaluated for the treatment of patients diagnosed with hepatocellular carcinoma (HCC) who have received one or two prior systemic anti-cancer therapies.The METIV-HCC trial is a randomized, double-blinded, controlled study of previously treated patients with MET-high inoperable HCC who will receive tivantinib or placebo. The primary endpoint is overall survival (OS), and the secondary endpoint is progression-free survival (PFS). Approximately 300 patients are planned to be enrolled at approximately 120 clinical centers worldwide. Additional details of the trial are available on www.clinicaltrials.gov.
“We are very pleased to begin this Phase 3 trial to advance our understanding of the potential role of tivantinib in the treatment of HCC,” said Glenn Gormley, MD, PhD, Global Head of Research and Development and Senior Executive Officer, Daiichi Sankyo. “It is our hope that this late-stage study will confirm the positive results we saw in Phase 2 in time to progression (TTP) and overall survival (OS) observed in patients whose tumors were MET-high.”
“Hepatocellular carcinoma is a devastating disease, and patients with advanced HCC are in need of new therapies that can help extend their lives,” said Paolo Pucci, chief executive officer of ArQule. “The METIV-HCC trial follows positive Phase 2 results that demonstrated improvements in overall survival and time to progression observed among MET-high patients.”
In October 2012, agreement was reached with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for this pivotal Phase 3 trial. The SPA process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a New Drug Application. Final marketing approval depends on the results of the trial.
About Hepatocellular Carcinoma (HCC)
Globally, liver cancer is the sixth most common cancer (749,000 new cases), accounting for 7 percent of all cancers, and is the third leading cause of cancer related death (692,000 cases).1 HCC represents more than 90 percent of primary liver cancers.2 Chronic hepatitis B and C are recognized as the major factors worldwide increasing the risk of HCC, with risk being even greater in the presence of co-infection with these viruses.3 Cirrhosis is also a risk factor for development of HCC.
About Tivantinib and the MET pathway
Tivantinib is an orally administered, selective inhibitor of MET, a receptor tyrosine kinase. Tivantinib is currently in Phase 3 development and has not been approved in any market. In healthy adult cells, MET is present in normal levels to support natural cellular function, but in cancer cells MET is inappropriately and continuously activated for unknown reasons. When abnormally activated, MET plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.

StephenW

第一制药三共株式会社和ArQule登记第一个肝癌病人到全球第三期临床试验为Tivantinib


东京和美国马萨诸塞州沃本， - （BUSINESS WIRE） -  2013年1月31日 - 第一制药三共株式会社有限公司（TSE 4568）和公司ArQule（纳斯达克：ARQL）今天宣布，在关键的第一个病人已经参加第3阶段METIV-HCC（MET高的患者在HCC与tivantinib）试验的tivantinib（ARQ 197）。 Tivantinib，MET，一种受体酪氨酸激酶选择性抑制剂的研究，目前正在评估收到一个或两个前全身抗癌治疗的肝细胞癌（HCC）患者的诊断与治疗。

的METIV-HCC试验是一项随机，双盲，对照研究MET-高不能手术的肝癌谁将会收到tivantinib或安慰剂治疗的患者。主要终点是总生存期（OS），次要终点是无进展生存期（PFS）。大约有300名患者计划将招收约120名世界各地的临床中心。审判的附加细节www.clinicaltrials.gov上可用的。

“我们很高兴开始第三期临床试验在治疗肝癌的的潜在作用tivantinib，以促进我们的理解，说：”格伦·葛姆雷，医学博士，博士，研究与发展高级行政主任，Daiichi Sankyo公司的全球主管。 “这是我们的希望，这后期阶段的研究将确认我们看到的积极成果，在第2阶段的时间进展时间（TTP）和总生存（OS）中观察到的肿瘤患者得到满足高。”

“肝癌是一种破坏性疾病，晚期肝癌病人需要新的治疗方法，可以帮助延长他们的生命，说：”保罗·普奇，行政总裁ArQule。 “METIV-HCC试验如下积极的第2阶段的结果表明改善整体的生存和发展MET-高的患者中观察到的时间。”

2012年10月，美国食品和药物管理局（FDA）达成了协议上的特殊评估协议（SPA），这个关键的第三期临床试验。 SPA的过程中是一个过程，其中FDA提供官方的评价和提出的协议，旨在形成一种新的药物应用的基础上的设计和大小的书面指导。最终市场的批准取决于试验结果。

关于肝癌（HCC）

在全球范围内，肝癌是全球第六大常见癌症（749,000新发病例），占所有癌症的7％，是第三大死因癌症相关的死亡（692000案件）的0.1 HCC占90％以上的原发性肝癌0.2慢性乙型和丙型肝炎被确认为世界各地的主要因素增加，风险更大的存在的这些viruses.3肝硬化合并感染是肝癌的危险也发展的HCC的一个危险因素。

关于Tivantinib和MET的途径

tivantinib是一种口服给药，MET，一种受体酪氨酸激酶的选择性抑制剂。 Tivantinib是目前在第三阶段的发展，并没有被批准任何市场。在健康的成年人细胞中，MET是存在于正常水平，以支持自然细胞的功能，但在肿瘤细胞中MET是不恰当的，不断激活，原因不明。当异常激活，MET在人类癌症方面扮演着多重角色，包括肿瘤细胞的生长，存活，新生血管形成，侵袭和转移。