新的强效丙肝治疗药物INX-189：首个临床试验成功完成

5 f+ e6 m- n+ |9 Y* f9 a) WPotent New Hepatitis C Drug: First Clinical Trials Successfully Completed
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ScienceDaily (Oct. 18, 2010) — The first clinical trials on a new investigational drug being developed to treat infections caused by Hepatitis C virus have been successfully completed.

Completion of the initial phase (phase 1a) of trials of INX-189, discovered and first prepared by researchers at Cardiff University's Welsh School of Pharmacy in 2008, means the chances of it becoming an approved medicine have significantly improved.

; O/ z2 V1 [8 H7 w: S2 VApproximately 170 million people worldwide are affected with Hepatitis C, which can lead to liver cancer, cirrhosis and death. It is the leading cause of liver transplantation in western countries. The current treatment involves two drugs -- ribavirin and interferon, which has to be given as an injection. Side effects are often severe and lead to patients failing to complete the treatment.

Professor Chris McGuigan of the Welsh School of Pharmacy, academic lead on the project, said: "This is still a very early stage of the trials process but none the less a significant development. Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg.

# v  G0 o# Z4 Q% S5 |8 `% p% M"The efficiency of drug release in this study has also confirmed that one single dose a day is most likely enough in treating the virus.

% U0 v4 A0 L$ y"We believe that INX-189 offers the possibility of more potency against Hepatitis, more rapid action in the liver, and fewer side effects than existing treatments."

6 F/ B$ ~! q7 i4 t( Q% t7 zIn 2008, laboratory tests showed INX-189 killed 90 per cent of the virus at very low (nanomolar) concentration, making it the most potent compound of its kind developed to date.

: w6 y; A  }! Z8 j1 ~! KUS pharmaceutical company Inhibitex, which owns the licence to INX-189 and has been working with the Cardiff team, has announced it is looking forward to a second trial (phase 1b), which would evaluate the compound's effectiveness in Hepatitis C patients.

Cardiff University and Inhibitex filed a patent on INX-189 earlier this year. It has been cleared for human clinical trials by the Food and Drug Administration in the US.
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! K6 \+ ^9 Q+ o+ h) K0 s1 @. I) {http://www.sciencedaily.com/releases/2010/09/100903104826.htm
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新的治疗丙肝强效药物：首个临床试验成功完成

! e- c/ `, k$ f( r4 _每日科学（2010-10-18）—用于治疗丙型肝炎病毒感染的新试验药物的首个临床试验成功完成。

INX-189初始阶段（phase 1a)的试验—被发现和第一次制备，与2008年在加的夫大学威尔士药学院（Cardiff University's Welsh School of Pharmacy）完成，这意味着INX-189被批准成为药物的机会大增。
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在全球范围内大约有1.7亿人被丙肝侵袭，丙肝有可能导致肝癌，肝硬化，甚至死亡，是西方国家的患者进行肝移植手术的首要原因。当前的治疗手段为两种药物—利巴韦林和干扰素注射给药，副作用通常非常严重以至于患者不能完成治疗。

" l5 L- E4 D9 F5 t+ j本项目的学术带头人，威尔士药学院的Chris McGuigan教授表示：这虽然只是试验进程非常早期的一步，但仍然是显著的进步。phase 1a试验的成功完成表明本药是安全的，单剂量给药100mg没有与药物相关的副作用。
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“在本次研究中对药物释放效率的考察表明每日给药一次足够用于对病毒的治疗。”

/ C" p# l  [1 X7 v+ O4 v" j“我们相信INX-189治疗肝炎可能有更好的效果，在肝内更速效，同时比现有的治疗手段具更少的副作用。”

在2008年，实验室研究表明INX-189在非常低的浓度下（纳摩尔级）就可以杀死90%的病毒,成为同类化合物中迄今为止的最强效的。

$ Q# l, F2 e6 p% H$ R美国制药公司Inhibitex拥有开发INX-189的权利并已经于加的夫大学的团队合作，宣布将进行phase 1b试验,以评价化合物在丙肝患者体内的效果。

+ w  j! e+ \( s加的夫大学和Inhibitex公司在年初提交了INX-189的一项专利，为FDA批准人体临床试验清除了障碍。

. ?4 x- _. r5 p0 J编者注：本文并非旨在提供医疗指导，诊断或治疗建议。

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