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发表于 2002-9-5 12:57
译自英文版（liver411）
ACH-126,443 (Beta-L-Fd4C)
InfoTrac Web: InfoTrac OneFile.
Source: Virus Weekly, April 2, 2002 p11.
Title: Phase II study of lead product candidate in hepatitis B patients
initiated.(Brief Article)
HBV的新型候选药物开始二期临床实验
Subjects: Pharmaceutical industry - Product development
Hepatitis B - Drug therapy
Companies: Achillion Pharmaceuticals Inc. - Product development
Locations: United States
SIC code: 2834
Electronic Collection: A84267466
RN: A84267466
Full Text COPYRIGHT 2002 NewsRX
2002 APR 2 - (NewsRx.com & NewsRx.net) -- Achillion Pharmaceuticals, a
privately held pharmaceutical company focused on the discovery, developm
ent and commercialization of innovative anti-infective agents, announced
the commencement of a phase II clinical study with the company's lead
product candidate, ACH-126,443 (Beta-L-Fd4C) in patients with chronic
hepatitis B infection.
Achillion Pharmaceuticals是一个私立药物公司，致力于研发和商品化革新的抗传染药物。
他们宣布，公司的新型候选药物，ACH-126,443 (Beta-L-Fd4C)，开始开始在HBV感
染者中进行二期临床实验。
This phase II study (Study 443-003) will help identify the optimal dose of
ACH-126,443 to treat patients chronically infected with hepatitis B virus
(HBV), defined as the dose, which most effectively suppresses hepatitis B,
DNA levels (viral load) while providing the best safety profile. This double-
blind study will evaluate several doses of ACH-126,443 administered once a
day to patients with chronic HBV infection, compared with lamivudine (3TC)
, and placebo. The 443-003 study will be conducted in multiple centers acro
ss central and eastern Europe under Achillion's investigational new drug (IND)
application filed with the U.S. Food and Drug Administration.
二期临床实验（实验号443-003）会有助于确定治疗慢性HBV的最佳药物剂量，确定最有效
抑制HBV病毒DNA水平（病毒载量）而有最安全的剂量。这个双盲实验要评估ACH-126,
443的很多不同剂量，同拉米夫定（3TC）和安慰剂对比。实验443-003要在中欧和东欧的
多个中心进行，由Achillion公司的调查中心实施，并在FDA备案。
"In 2 years from the launch of Achillion, we have advanced ACH-126,443
fromearly preclinical testing into phase II efficacy trials. This rapid entry into
clinical development underscores the value of the experience of our team to
deliver major milestones successfully," said William G. Rice, Achillion's
chief executive officer. "Chronic hepatitis B infection is a silent epidemic
with an enormous need for additional and superior therapeutics. With existing treatments, the medical needs of patients are often not met due to adverse side effects or loss of efficacy because of viral resistance."
Achillion公司的CEO，William G. Rice说：“在Achillion公司研发的两年中，我们推进了
ACH-126,443从预研到二期实验。迅速的进入临床实验，显示了我们团队经验的价值，达到
了一个成功的里程碑。”“慢性HBV感染是种无声的传染病，急需新的高效疗法。用现有的
疗法，病人经常得不到需要的治疗，因为副作用，或病毒变异。”
"The preclinical data on ACH-126,443 indicate potency against HBV strains
that are both sensitive and resistant to lamivudine, the only currently approv
edoral anti-HBV drug," commented Lisa M. Dunkle, MD, senior vice president
of drug development for Achillion. "Our previous clinical studies have demonst
rated very promising safety and antiviral activity of the compound. We look
forward to the data from this current study to provide more definitive inform
ation regarding the safety and efficacy of several doses ofACH-126,443."
Achillion公司的副总裁，Lisa M. Dunkle说：“预研的数据显示出ACH-126,443有能力
对抗对拉米夫定敏感或抗药的病毒株（拉米，目前唯一批准的抗HBV药物）。我们过去的研究
证实该化合物可靠的安全性和抗病毒能力。我们期望当前的实验能提供关于安全性和不同剂量
效果更确定的信息。
This article was prepared by Virus Weekly editors from staff and other
reports.
本文由Virus Weekly编辑根据有关资料整理而成。
-- End --
[此贴子已经被特深沉于2002-9-4 23:57:42编辑过]
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