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http://www.rttnews.com/Content/BreakingNews.aspx?Node=B1&Id=1550798
(RTTNews) - Biopharmaceutical company Inhibitex, Inc. (INHX: News) Friday stated that the U.S. Food and Drug Administration has given fast track designation to INX-0818, an investigational treatment for chronic hepatitis C viral infection. Hepatitis C is a liver disease caused by hepatitis C virus or HCV. It is estimated that over 170 million people worldwide are infected with HCV.
INX-189 is a potent guanosine nucleotide polymerase inhibitor. On January 9, Inhibitex had reported interim data from the first two cohorts of its ongoing Phase 1b clinical trial of INX-189. The company expects to complete this trial by the end of the first quarter of 2011.
Inhibitex believes that preclinical and clinical studies of INX-189 completed to-date support its potential as a potent, once-daily, low dose oral therapy, which can be used in combination with other antivirals for the treatment of patients with all known genotypes of HCV.
The FDA's fast track programs are designed to expedite the development and review of new drugs that are intended to treat serious or life threatening diseases for which no other drug exists or works well. Inhibitex said that the FDA granted INX-189 the fast track status due to high genetic barrier to resistance, its pan-genotypic activity, and once-daily oral dosing.
（综合讯） -生物制药公司Inhibitex公司（INHX：新闻）周五表示，美国食品和药物管理局已发出INX的快车道委派-0818，一对慢性丙型肝炎病毒感染的研究性治疗。
丙型肝炎是一种肝脏疾病，丙型肝炎病毒或丙型肝炎病毒引起的。据估计，全世界超过1.7亿人是丙型肝炎病毒感染。
INX的- 189是一种有效的鸟核苷酸聚合酶抑制剂。 1月9日，Inhibitex曾报道的前两个阶段第1B其正在进行的INX的- 189临床试验的同伙临时数据。该公司预计将完成由2011年第一季度结束这场审判。
Inhibitex认为，INX的- 189临床前和临床研究完成的最新支持一个强有力的，每日一次，低剂量的口服治疗，它可以组合使用对患者的治疗与其他抗病毒药物与所有已知基因型的潜力丙型肝炎病毒。
FDA的快速通道方案的目的是加快发展和被用于治疗严重或危及生命的疾病，这是任何其他药物存在或运作良好，新药审评。 Inhibitex说，美国FDA批准INX的- 189的快速跟踪状态，由于高基因屏障的抵抗，其泛基因型活动，每日一次口服。
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发表于 2011-2-11 23:13