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Vical宣布与AnGes联合开发治疗慢性乙型肝炎感染的计划 [复制链接]

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发表于 2017-10-25 09:41 |只看该作者 |倒序浏览 |打印
Vical Announces Joint Development Program With AnGes on a Treatment for Chronic Hepatitis B Infection

October 24, 2017 06:30 ET | Source: Vical Incorporated

SAN DIEGO, Oct. 24, 2017 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today that it is pursuing early stage development of a novel treatment for chronic hepatitis B virus (CHB) infection based on its DNA and lipid-delivery technologies. This development effort is being conducted in collaboration with Vical’s strategic partner, AnGes, Inc of Osaka, Japan. The initial stage of this program will be to demonstrate preclinical proof of concept for inhibiting HBV infection in a human liver model in the second half of 2018. The ultimate aim of this program would be to demonstrate eradication of persistent HBV infection in CHB patients.  

AnGes has provided partial funding for the initial stage of this program and, if successful, Vical expects that AnGes will continue to participate in the funding of the program. AnGes has been granted the right of first refusal to negotiate with Vical for an exclusive license to develop and commercialize this therapy in Japan.

Vical intends to first establish in vitro proof of concept against HBV infection using an HBV-producing cell line followed by in vivo testing in an elaborate preclinical model of HBV infection which enables human hepatocytes to be infected with HBV and then treated and monitored for suppression of several virologic markers including reduction in covalently-closed circular (ccc) DNA levels in the livers. Should Vical establish in vivo proof of concept, it intends to advance the product towards Phase 1 testing, ideally in CHB patients, to achieve clinical proof of concept at an early stage of development. Results of the preclinical proof of concept studies are anticipated in the second half of 2018.

About chronic HBV infection
Chronic HBV infection affects nearly 250 million people worldwide and an estimated 786,000 deaths are attributed annually to CHB infection worldwide. People with CHB infection are at increased risk for severe liver disease, with 15% to 40% developing cirrhosis or hepatocellular carcinoma. Although currently-available antiviral drugs effectively inhibit the HBV reverse transcriptase and suppress viral replication while the drugs are taken, they typically lead to only a 1% to 3% per year cure rate. The persistence of cccDNA in infected liver cells is not altered by the antiviral drugs so novel treatments are necessary to eliminate this reservoir and produce a long term cure, thereby reducing the need for lifelong antiviral drug use. Vical’s approach is intended to address the underlying cause of persistent HBV infection – cccDNA– by targeting hepatocytes and using molecular interventions to inactivate the cccDNA harbored within hepatocyte nuclei.

About Vical
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.

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发表于 2017-10-25 09:42 |只看该作者
Vical宣布与AnGes联合开发治疗慢性乙型肝炎感染的计划

2017年10月24日06:30 ET |资料来源:Vical Incorporated

圣地亚哥,2017年10月24日(GLOBE NEWSWIRE) - Vical Incorporated(纳斯达克股票代码:VICL)今天宣布,它正在追求基于其DNA和脂质体的慢性乙型肝炎病毒(CHB)感染的新型治疗的早期发展,交付技术。这一开发工作正在与Vical的战略合作伙伴AnGes,Inc(日本大阪)合作进行。该计划的初始阶段将在2018年下半年展示用于抑制人类肝脏模型HBV感染的临床前证据。该计划的最终目的是说明CHB患者的HBV持续感染的根除。

AnGes已经为该计划的初始阶段提供了部分资金,如果成功,Vical预计AnGes将继续参与该计划的资助。 AnGes被授予首先拒绝与Vical谈判获得在日本开发和商业化该药物的独家许可的权利。

Vical打算首先使用HBV产生细胞系建立体外的HBV感染概念,然后在HBV感染的精心制作的临床前临床模型中进行体内测试,以使人类肝细胞感染HBV,然后进行治疗和监测几种病毒学标志物,包括在肝脏中共价闭合的环状(ccc)DNA水平的降低。如果Vical建立体内的概念证明,它打算将产品推进到第一阶段测试,理想情况下在CHB患者中,以在发展的早期阶段实现临床证据概念。概念研究的临床前证据预计在2018年下半年。

关于慢性HBV感染
慢性乙型肝炎病毒感染影响全球近2.5亿人,估计每年有78.6万人死于全球CHB感染。 CHB感染者患重度肝病风险增加,15%〜40%发生肝硬化或肝细胞癌。虽然目前可用的抗病毒药物有效地抑制HBV逆转录酶,并且在服用药物时抑制病毒复制,但它们通常仅导致每年1%至3%的治愈率。感染肝细胞中cccDNA的持续性不被抗病毒药物改变,因此需要新的治疗来消除这种储存并产生长期治愈,从而减少终身抗病毒药物使用的需要。 Vical的方法旨在通过靶向肝细胞解决持续性HBV感染cccDNA的潜在原因,并使用分子干预来灭活肝细胞核内的cccDNA。

关于Vical
Vical根据其专利的DNA递送技术和其他治疗方法开发用于预防和治疗慢性或危及生命的传染病的生物制药产品。有关Vical的更多信息,请访问www.vical.com

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发表于 2017-10-25 22:41 |只看该作者
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