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两个临床试验,第一个结果将公布上半年的2015年
LOUISVILLE, CO--(Marketwired - March 17, 2015) - GlobeImmune, Inc. (NASDAQ: GBIM) today provided an update on the Company's business and clinical programs, and announced financial results for the full year ended December 31, 2014.
Program Updates
GS-4774 for Chronic Hepatitis B Infection
GS-4774 is a Tarmogen designed to treat patients chronically infected with HBV who are also on, or are candidates for, oral antiviral suppressive therapy. GS-4774 is being developed pursuant to a worldwide collaboration agreement with Gilead Sciences, Inc., and is currently being evaluated in two randomized Phase 2 trials:
GS-US-330-0101, or the 0101 trial, is a randomized Phase 2 clinical trial, initiated in 2013, investigating GS-4774 in combination with ongoing oral antiviral treatment in patients with chronic HBV infection. The 0101 trial is a multicenter, multinational trial that enrolled 175 patients in a randomized, open-label design comparing three different doses of GS-4774, administered in combination with oral antiviral therapy versus antiviral treatment alone. The primary endpoint for this trial is decline in serum HBV surface antigen, or HBsAg. The 0101 trial is fully-enrolled, and 48-week results are expected to be available in the first half of 2015. These results may be submitted to an upcoming scientific conference.
GS-US-330-1401, or the 1401 trial, is a randomized Phase 2 clinical trial, initiated in 2014, investigating GS-4774 in patients with chronic HBV infection who are currently not receiving treatment. The 1401 trial is a multicenter, multinational trial designed to enroll 175 patients in a randomized, open-label design comparing three different doses of GS-4774, administered in combination with tenofovir disoproxil fumarate, or TDF, versus TDF alone. The 1401 trial is actively enrolling patients. The 48-week results are projected to be available in the middle of 2016.
路易斯维尔,CO - (Marketwired - 2015年3月17日) - GlobeImmune公司(NASDAQ:GBIM)今天提供对公司的业务和临床项目的最新情况,并公布财务业绩全年截至2014年12月31日。
程序更新
GS-4774用于慢性乙型肝炎病毒感染
GS-4774是专为治疗谁也上,或者是候选,口服抗病毒药物抑制治疗的患者慢性感染HBV一个Tarmogen。 GS-4774正在根据研制与吉利德科学公司的全球合作协议,目前正在两个随机第二阶段试验评估:
GS-US-330-0101,或0101试验,是一项随机二期临床试验,2013年开始,在慢性HBV感染正在进行口服抗病毒治疗研究GS-4774的组合。 0101试验是一项多中心,跨国试验,纳入175例患者中比较了三种不同剂量的GS-4774,下辖联合口服抗病毒治疗与单纯抗病毒治疗的随机,开放标签的设计。该试验的主要终点是下降血清HBV表面抗原,乙肝表面抗原或。 0101试用完全录取,和48周的结果预计将在第一的2015年,这些结果可能一半提交给即将到来的科学会议。
GS-US-330-1401,或1401试验,是一项随机二期临床试验,2014年开始,在慢性HBV感染者谁是目前不接受治疗调查GS-4774。 1401试用版,旨在招收175例在比较了三种不同剂量的GS-4774,下辖与富马酸替诺福韦酯,或TDF,TDF与单独组合,随机,开放标签设计的多中心,多国的审判。 1401试验正在积极招募患者。在48周的结果,预计可于2016年的中间。
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