GlobeImmune宣布 GS4774 (GI-13020)启动二期临床试验

StephenW

GlobeImmune Announces Milestone Payment for Initiation of Phase 2 Clinical Trial for GS-4774 (Formerly GI-13020) in Patients with Chronic Hepatitis B Virus Infection


(Thomson Reuters ONE via COMTEX) -- LOUISVILLE, Colo., October 15, 2013 - GlobeImmune, Inc., today announced that it has earned a milestone payment from Gilead Sciences, Inc. under the terms of an exclusive worldwide license and collaboration agreement established in 2011 for the development and commercialization of Tarmogen products® for use in conjunction with Viread® (tenofovir disoproxil fumarate) and other oral therapies for the treatment of chronic hepatitis B virus (HBV) infection.

The milestone payment is based on the initiation of a Phase 2 clinical trial investigating GS-4774 (formerly GI-13020) in patients with chronic hepatitis B virus (HBV) infection. The GS-4774 Tarmogen, consists of whole, heat-killed, recombinant S. cerevisiae yeast genetically modified to express HBV antigens.

The Phase 2 clinical trial will enroll patients in a randomized, open-label trial evaluating different doses of GS-4774 in virally-suppressed patients. In addition to continuing ongoing oral antiviral treatment, patients will be treated with GS-4774 administered once per month. The primary endpoint for this trial is decline in serum HBV surface antigen (HBsAg). Surface antigen seroconversion defines a cure in chronically infected patients.

"GS-4774 demonstrated a favorable safety and immunogenicity profile in a previous Phase 1 clinical trial, which paved the way for the initiation of this Phase 2 study," said Timothy C. Rodell, M.D., Chief Executive Officer at GlobeImmune. "We believe that the antigen-specific immune response against HBV driven by GS-4774 may improve rates of seroconversion in patients already being treated with antiviral therapy."

HBV infection is the most common form of chronic viral hepatitis in the world. Approximately 350 million people worldwide are chronic carriers of HBV, resulting in more than 620,000 deaths annually from liver-related diseases. In the United States, chronic HBV infection affects up to 1.4 million people. Current treatment for HBV includes once-daily oral antiviral therapy medicines to suppress virus replication. These antiviral products have been effective in controlling the disease but generally do not result in a long-term cure, thus requiring chronic suppressive therapy.

For more information on the trial, please visit http://www.clinicaltrials.gov/.

StephenW

（路透ONE通过COMTEX ） - 路易斯维尔，科罗拉多州， 2013年10月15日 - GlobeImmune公司，今天宣布，它已经赢得了里程碑付款从吉利德科学公司的全球独家授权和合作协议的条款下成立于2011年的开发和商品化的Tarmogen产品®用于结合的Viread ®（富马酸替诺福韦酯）和其他口服疗法治疗慢性乙型肝炎病毒（HBV）感染。

里程碑付款的基础上开始第2阶段临床试验调查GS -4774 （前身为GI -13020 ）在慢性乙型肝炎病毒（HBV）感染的患者。 GS -4774 Tarmogen的，整体而言，热杀害，重组酿酒酵母酵母转基因表达HBV抗原组成。

第2阶段临床试验将招募患者的随机，开放标签试验评价不同剂量的GS - 4774维拉利抑制患者。在除了继续持续口服抗病毒药物治疗，患者将被视为与GS -4774管理，每月一次。这项试验的主要终点是血清乙肝病毒表面抗原（HBsAg）的下降。表面抗原血清学转换定义在慢性感染患者治愈。

蒂莫西C.罗德尔，医学博士，行政总裁GlobeImmune “ GS - 4774表现出了良好的安全性和免疫原性，说：”在以前的第1阶段临床试验，这次2期研究的启动铺平了道路。 “我们相信， GS - 4774驱动抗HBV抗原特异性免疫反应已经正在接受抗病毒治疗的患者中，血清转换率可能会提高。”

HBV感染是慢性病毒性肝炎在世界上最常见的形式。全球大约有350万人是慢性乙肝病毒携带者，肝脏相关的疾病每年导致超过620,000人死亡。在美国，慢性乙肝病毒感染会影响到1.4万人。目前HBV治疗包括每日一次口服抗病毒治疗药物抑制病毒的复制。这些抗病毒产品已经有效地控制疾病，但一般不会导致一个长期的治疗，因此需要慢性抑制疗法。

上试欲了解更多信息，请访问http://www.clinicaltrials.gov/ 。

疯一点好

谢谢斯蒂芬，这是好消息，希望可以真正清楚表面抗原。

希望奇迹

希望有说的这么好！

咬牙硬挺

希望进展顺利，尽快上市，价格不要太高