ABX203首先患者IIb期/ III的临床试验

newchinabok

三个臭皮匠，顶个诸葛亮，核苷，arc520，古巴疫苗组合起来，清除hbsag有大希望

StephenW

ABIVAX Strengthens Its Senior Leadership Team by Appointing Dr. Jean-Marc Steens, M.D. as the Company’s Chief Medical Officer
September 23, 2015 01:17 PM Eastern Daylight Time

PARIS--(BUSINESS WIRE)--Regulatory News:

    “I am looking forward to applying my experience and learnings to the development of ABIVAX’s ground-breaking therapies, which I am confident will have a substantial effect on the lives of many patients worldwide currently suffering from chronic Hepatitis B and HIV.”

ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a publicly traded, clinical stage biotech company developing and commercializing anti-viral drugs and therapeutic vaccines, today announced the appointment of Dr. Jean-Marc Steens, M.D. as its Chief Medical Officer.

Dr. Steens joins ABIVAX with almost three decades of experience in the biopharmaceutical industry. During these years, he held critical leadership roles with a focus on viral diseases (especially HIV/AIDS, but also hepatitis B) in both global clinical development and medical affairs. Furthermore, he has lived and worked in Europe and in the Unites States, and has had roles whose scope also included developing markets.

Prof. Hartmut Ehrlich M.D., CEO of ABIVAX, stated: “I am delighted to welcome Jean Marc to ABIVAX’s senior leadership team. His broad experience in the field of anti-viral drugs and vaccines, developed through decades of international leadership roles at GSK and ViiV, will be invaluable for the ongoing development of ABIVAX’s first-in-class clinical-stage product candidates ABX464 (HIV/AIDS) and ABX 203 (chronic hepatitis B), and to our pipeline of pre-clinical anti-viral compounds.”



Dr. Steens completed his medical education as well as a post-doctoral degree in Public Health at the Catholic University of Louvain in Belgium. He began his career at Sandoz in Belgium and subsequently joined Glaxo where he stayed for more than 20 years and carried extensive responsibilities for the global clinical development, medical affairs and access programs for novel therapies and vaccines for HIV and other infectious diseases.

In 2009, Dr. Steens was appointed to the post of Vice President and International Medical Director of ViiV Healthcare, with responsibility for establishing and managing medical departments across Eastern Europe, Asia and Latin America. In this capacity, he was ViiV Healthcare’s appointed liaison with guideline bodies including the WHO and the Medical Research Council (UK).

Since 2013, Dr. Steens has consulted to various Biopharmaceutical companies, including Novartis. Also, Dr. Steens is a member of the HIV advisory boards and steering committees of several global and national healthcare organizations such as the WHO and the National Institutes of Health (US).

StephenW

ABIVAX任命医生让 - 马克·Steens博士为公司的首席医疗官巩固其高层领导团队
2015年9月23日下午1时17东部夏令时间

巴黎 - （美国商业资讯） - 监管新闻：

    “我期待着运用我的经验和学习到ABIVAX的突破性疗法，这我相信将有不少世界各地的患者目前慢性乙肝和HIV痛苦的生活产生重大影响的发展。”

ABIVAX（巴黎：ABVX）（巴黎证交所：FR0012333284 - ABVX），一家公开上市，临床阶段的生物技术公司，开发和商业化的抗病毒的药物和治疗性疫苗，今天宣布让 - 马克Steens博士的任命，医学博士为首席医疗官。

Steens博士加入ABIVAX有近三十年的生物制药行业的经验。在这些年里，他担任重要的领导角色，重点是病毒性的疾病（特别是艾滋病毒/艾滋病，而且乙肝）在这两个全球临床开发和医疗事务。此外，他一直生活在欧洲和团结状态工作，并曾角色，其范围也包括发展中市场。

教授哈特穆特·埃利希MD，ABIVAX首席执行官表示：“我非常高兴地欢迎让·马克以ABIVAX的高级领导团队。他在抗病毒的药物和疫苗，经过几十年的葛兰素史克和欢跃国际领导角色开发领域的丰富经验，将是非常宝贵的ABIVAX的先入级临床试验阶段的产品候选人ABX464（艾滋病毒/艾滋病的持续发展）和ABX 203（慢性肝炎B）和我们的临床前抗病毒化合物的管道“。



Steens博士完成他的医学教育和博士后学位，公共卫生在鲁汶在比利时天主教大学。他的职业生涯始于山德士在比利时和后来加入葛兰素他在那里住了20多年，并进行广泛的责任，为全球临床开发，医疗事务和访问程序的新疗法和疫苗艾滋病毒和其他传染病。

2009年，Steens博士被任命为欢跃医疗的副总裁兼国际医疗主任的职务，以建立和整个东欧，亚洲和拉丁美洲的管理医技科室的责任。在这个职位上，他是欢跃医疗集团与指导机构，包括世界卫生组织和医学研究理事会（英国）任命了联络。

自2013年，Steens博士咨询了各种生物制药公司，包括诺华公司。此外，Steens博士是一些全球和国家医疗保健组织，如世界卫生组织和美国国立卫生研究院（美国）的艾滋病咨询委员会和指导委员会的成员。

StephenW

MP4 发表于 2015-9-23 22:59
是的，不过中国很早就批准了基因药物上市。也已经批准了乙肝治疗性基因疫苗（DNA疫苗）临床试验 ...

基因疗法涵盖了广泛领域.

插入一个质粒(plasmid), 基因编辑(gene editing)是完全不同的。基因编辑带有很大的风险。
"如2015年6月的仅一个人DNA疫苗已被批准用于人类使用，在2010年发布[单剂量的日本脑炎疫苗叫IMOJEV"

MP4

StephenW 发表于 2015-9-24 14:55
基因疗法涵盖了广泛领域.

插入一个质粒(plasmid), 基因编辑(gene editing)是完全不同的。基因编辑带有 ...

DNA疫苗不编辑人的基因，所以原则上不是基因治疗，但是管理上按基因治疗一样评价安全性再上的。
你说的IMOJEV不是DNA疫苗，因为黄热病毒是RNA病毒。

StephenW

MP4 发表于 2015-9-24 20:24
DNA疫苗不编辑人的基因，所以原则上不是基因治疗，但是管理上按基因治疗一样评价安全性再上的。
你说的IM ...

IMOJEV is a monovalent, live attenuated viral vaccine. The virus was obtained via recombinant DNA technology. It is based on the 17D-204 yellow fever vaccine virus in which two genes have been replaced by the corresponding genes from Japanese encephalitis (JE) virus. These are the premembrane (prM) and envelope (E) coding sequences of the SA14-14-2 live attenuated JE
vaccine virus. The immunising antigens are the prM and E proteins from the SA14-14-2 vaccine
virus.

DNA vaccination is a technique for protecting an animal against disease by injecting it with genetically engineered DNA so cells directly produce an antigen, resulting in a protective immunological response. Several DNA vaccines have been released for veterinary use, and there has been promising research using the vaccines for viral, bacterial and parasitic diseases, as well as to several tumour types. Although only one DNA vaccine has been approved for human use, DNA vaccines may have a number of potential advantages over conventional vaccines, including the ability to induce a wider range of immune response types.

DNA疫苗使用DNA生产病毒（DNA或RNA病毒）抗原.

StephenW

ABIVAX Completes Recruitment in Its Phase IIb/III Pivotal Study with ABX203, First-in-Class Therapeutic Vaccine Against Chronic Hepatitis B
September 24, 2015 12:51 PM Eastern Daylight Time

PARIS--(BUSINESS WIRE)--Regulatory News:

    “We are very pleased with this important clinical development milestone that demonstrates the efficiency of the relationship between ABIVAX and the CIGB”

ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a leading clinical stage biotech company developing and commercializing therapeutic anti-viral drugs and vaccines, today announced that it has completed enrollment of all 266 subjects into its pivotal Phase IIb/III clinical trial of ABX203, aimed at demonstrating the safety and efficacy of ABX203, a therapeutic vaccine candidate for the treatment of patients with chronic hepatitis B disease. This is a significant milestone for the company, which recently conducted an IPO on the regulated market of Euronext Paris and set a record among biotechnology companies in France in terms of the amount of funds raised.

“We are delighted to announce that ABIVAX has successfully and rapidly fully enrolled 266 patients for this essential study. The enthusiasm of the physicians and investigators involved in the study is evident. This not only highlights the interest in our innovative therapeutic vaccine, but also underlines the medical need for immunotherapy in this indication. This is an important milestone for ABIVAX that should enable us to generate the first study results in Q4/2016,” said Prof. Hartmut J. Ehrlich, M.D., CEO of ABIVAX.

“We are very pleased with this important clinical development milestone that demonstrates the efficiency of the relationship between ABIVAX and the CIGB,” added Luis Herrera Martinez, CEO of the Cuban Center for Genetic Engineering and Biotechnology (CIGB), and Gerardo Guillén Nieto, Director of Biomedical Investigation at the CIGB.

Chronic Hepatitis B (CHB) virus infection is a very severe disease that often leads to life-threatening complications such as cirrhosis and liver cancer. There are approximately 350 million chronic carriers of Hepatitis B virus (HBV) worldwide, and between 1.0 and 1.5 million people die each year from these complications. CHB is present worldwide but its prevalence is highest in Sub-Saharan Africa and in East Asia.

The ABX203 phase IIb/III study is an open-label, randomized, comparative study designed to assess the efficacy of ABX203 to maintain control of Hepatitis B disease after cessation of nucleotide analogs, in particular in controlling viral load for a much longer period of time when compared to current treatment options. This study is ongoing in seven Asian/Pacific countries (Taiwan, Hong-Kong, Thailand, Singapore, South Korea, Australia and New-Zealand). In this large scale controlled and randomized study, one group of patients will receive ABX203 for 24 weeks, in addition to the current standard of care (nucleoside analogues, NUCs, along with alpha interferon); therapy will be stopped after 24 weeks. These patients will be evaluated against a control group receiving NUCs only. The study’s primary efficacy endpoint is the percentage of subjects with viral load <40 IU/mL at week 48, i.e 24 weeks after the treatment with ABX203 has been completed. Study results are expected in the fourth quarter of 2016.

ABX203 is a therapeutic vaccine composed of 2 recombinant proteins from HBV, the surface antigen (HBsAg) and the nucleocapsid (core) structure (HBcAg). It has been designed to induce the production of neutralizing serum antibodies to HBsAg and the induction of strong cellular responses, which are usually weak or undetectable in patients with CHB. These immune responses are similar to those that occur in patients with a self-resolving acute HBV infection. ABX203 is formulated as a nasal spray solution and as a solution for sub-cutaneous injection.

ABIVAX owns the development and distribution rights for ABX203 for more than 80 territories in Asia, Europe and Africa. These rights were licensed in 2013 from the Center for Genetic Engineering and Biotechnology (CIGB, Havana, Cuba) following the completion of successful phase I, I/II and III clinical trials run by the CIGB. These studies showed that ABX203 was well tolerated and had an antiviral effect similar to that of PEG-IFNα but that this effect on HBV viral load was, in contrast with PEG-IFNα, sustained for at least 6 months after treatment cessation. This unique sustained effect, in addition to a shorter duration of administration, means that ABX203 may offer important therapeutic advantages over standard treatments for CHB.

StephenW

ABIVAX完成对招聘中它的阶段IIb /与ABX203，先入级治疗性疫苗的慢性乙型肝炎III关键研究
2015年9月24日下午12时51分东部夏令时间

巴黎 - （美国商业资讯） - 监管新闻：

    “我们很高兴能与这个重要的临床发展具有里程碑意义，演示ABIVAX和CIGB之间的关系的效率”

ABIVAX（巴黎：ABVX）（巴黎证交所：FR0012333284 - ABVX），一家领先的临床阶段的生物技术公司，开发和商业化治疗性抗病毒的药物和疫苗，今天宣布，它已经完成了所有266科目登记到其举足轻重的IIb / III期ABX203的临床试验，旨在展示ABX203，治疗疫苗候选慢性乙型肝炎病的药物中的安全性和有效性。这是一个显著的里程碑，为公司，它最近的巴黎Euronext监管市场上进行首次公开​​募股，并设置生物技术公司在法国之间的纪录，募集资金量而言。

“我们很高兴地宣布，ABIVAX已成功，并迅速完​​全纳入266例患者为这一重要的研究。参与这项研究的医生和研究人员的积极性是显而易见的。这不仅凸显了我们创新的治疗性疫苗的兴趣，同时也强调了免疫治疗在此适应症的医疗需要。这是ABIVAX一个重要的里程碑，应该使我们能够产生的第一项研究成果在第4季度/ 2016年，“教授哈特穆特·J.埃利希，MD，ABIVAX首席执行官。

“我们很高兴能与这个重要的临床发展具有里程碑意义，演示ABIVAX和CIGB之间的关系的效率，补充说：”路易斯·埃雷拉·马丁内斯，古巴中心的遗传工程和生物技术（CIGB）的首席执行官，和赫拉尔多·纪廉涅托，董事生物医学研究在CIGB。

慢性乙型肝炎（CHB）的病毒感染是一个非常严重的疾病，往往导致威胁生命的并发症，如肝硬化和肝癌。大约有乙型肝炎病毒（HBV）的3.5亿慢性携带者全世界，并且在1.0和1.5百万人每年死于这些并发症。慢性乙型肝炎是目前全球范围内，但其患病率最高的撒哈拉以南非洲和东亚。

所述ABX203 IIb / III阶段研究是一个开放标记，随机，对照，旨在评估ABX203的功效，以保持停止的核苷酸类似物的后控制乙型肝炎病，特别是研究在控制病毒负荷的时间长得多的时间相比，目前的治疗方案时。这项研究是持续的在七个亚洲/太平洋地区国家（台湾，香港，香港，泰国，新加坡，韩国，澳大利亚和新西兰）。在这种大规模的控制，随机研究中，一组的患者将接受ABX203 24周，除了护理的当前标准（核苷类似物，NUCs，随着α干扰素）;治疗将在24个星期后停止。这些患者将评估对对照组只接受NUCs。该研究的主要功效终点是受试者病毒载量<40 IU / mL的在48周的百分比，即带有ABX203治疗后24周已经完成。研究结果预计将在2016年第四季度。

ABX203是治疗性疫苗从HBV的由2重组蛋白，所述表面抗原（HBsAg）和核衣壳（芯）结构（核心抗原）。它被设计为诱导中和血清抗体对HBsAg的生产和强细胞应答，这通常是弱的或不可检测CHB患者的诱导。这些免疫应答类似于发生在患者的自分辨急性HBV感染。 ABX203被配制成鼻喷雾溶液，并作为皮下注射的溶液。

ABIVAX拥有超过80领土在亚洲，欧洲和非洲的ABX203开发和经销权。在2013年从中心遗传工程和生物技术（CIGB，哈瓦那，古巴）完成成功阶段I，I / II和III期临床试验由CIGB运行下面的这些权利被许可。这些研究表明，ABX203的耐受性良好，并具有类似的PEG-IFNα的抗病毒效果，但其对HBV病毒载量这样的效果是，在用PEG-IFNα相反，持续至少6个月的治疗停止后。这种独特的持续性的影响，除了给药时间较短，意味着ABX203可以提供优于用于CHB标准治疗重要的治疗优点。

ivanich

百舸争流，好事情啊！我感觉拔出HBV就剩一层窗户纸了！

肝肠欲断

黎明就要过去了