TG1050今天宣布，第一个病人已被纳入第一阶段/ 1b试验

StephenW

                                            

•         Continuation of the trial following the positive recommendation of         the Safety Review Committee (July 2016)
•         First data readout expected in H2 2017
  

                                 
                                                                                                                                                                                                                         October 17, 2016 12:00 PM Eastern Daylight Time                                                       
                                                                                                       

STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:   

          Transgene (Paris:TNG) (Euronext Paris: TNG), a company focused on       designing and developing targeted immunotherapies for the treatment of       cancer and infectious diseases, today announced that the first patient       has been included in the multiple dose cohort of the Phase 1/1b trial       with TG1050, Transgene’s immunotherapy product candidate for the       treatment of chronic hepatitis B virus (HBV) infection (NCT: 02428400).   
          The continuation of the trial in the multiple dose cohorts follows the       positive recommendation of the Safety Review Committee (July 2016) as no       severe adverse events have been observed in patients receiving a single       dose of TG1050.   
          This first-in-man trial is an international, randomized, multi-center,       double-blind, placebo-controlled study evaluating TG1050 in patients who       are currently being treated for chronic HBV infection with       standard-of-care antiviral therapy. The primary objectives of the       Phase 1/1b study are to evaluate the safety and tolerability of TG1050       administered in single and multiple doses and to determine the dose and       schedule of TG1050 administration for further development. Secondary       objectives include evaluating the antiviral activity of and immune       responses to TG1050. First data readout is expected in H2 2017.   
          TG1050 is a targeted immunotherapy candidate for the treatment of       chronic hepatitis B, based on a viral vector expressing three HBV       antigens. It is a therapeutic vaccine that has been designed and       developed by Transgene’s antiviral research team. Preclinical results       have demonstrated TG1050’s capacity to induce robust, broad and       long-lasting HBV-specific T cells with characteristics similar to those       found in patients whose infection has been resolved1.       Antiviral effects of TG1050, including seroconversion to the surface       antigen (HBsAg), have also been shown1 2.   
          Chronic hepatitis B is a major unmet medical need, as current treatments       only cure about 3% of the patients. With TG1050, Transgene is looking to       provide a much more-effective treatment that is urgently needed for this       viral liver disease, which can lead to cirrhosis and liver cancer.   
          About Chronic Hepatitis B
Hepatitis B is a       potentially life-threatening liver infection caused by HBV infection. It       can result in chronic infection and liver disease and, if left       untreated, puts people at high risk of death from cirrhosis of the liver       and liver cancer. Recent figures indicate the number of patients being       treated for chronic hepatitis B was 200,000 in total in the United       States, Germany, France, Italy, Spain and the United Kingdom and 100,000       patients in Japan. The eligible Chinese market represents 500,000       patients. Those numbers are expected to increase as more patients are to       be diagnosed and treated for their disease in the coming years (Sources:       ECDC- Incidence of Hepatitis B, Decision Resources: expert opinions).       Currently available antiviral treatments cure only an estimated 3% of       cases, and patients in the developed world must take these treatments       for an average of 15 years and often for their lifetime. Therefore,       there is an urgent need to develop new therapeutic approaches to improve       the cure rate.   
          About TG1050
TG1050 is a targeted immunotherapy       candidate for the treatment of chronic hepatitis B, based on a viral       vector expressing 3 HBV antigens. Transgene has initiated a randomized,       multi-center, double-blind, placebo-controlled safety and dose-finding       first-in-man study (NCT02428400) evaluating the safety and tolerability       of TG1050 in patients who are currently being treated for chronic HBV       infection with standard-of-care antiviral therapy. The technology of       TG1050 is also being developed in China, where it is currently under       SFDA evaluation and has been recently granted an IND number. In
China,       Transgene operates a joint-venture with Tasly Biopharmaceutical       Technology.
The latest publications on TG1050 are available on: www.transgene.fr.   

StephenW

TG1050今天宣布，第一个病人已被纳入第一阶段/ 1b试验

    在安全审查委员会的积极建议之后继续审判（2016年7月）
    第一次数据读数预计在2017年下半年

October 17，2016 12:00 Eastern Eastern Daylight Time

法国斯特拉斯堡 - （BUSINESS WIRE） - （美国商业资讯） - 监管新闻：

Transgene（巴黎：TNG）（Euronext巴黎：TNG），一家专注于设计和开发针对癌症和传染病治疗的靶向免疫疗法的公司，今天宣布，第一个病人已被纳入第一阶段/ 1b试验与TG1050，Transgene的免疫治疗产品候选人治疗慢性乙型肝炎病毒（HBV）感染（NCT：02428400）。

多剂量队列中的继续试验遵循安全性审查委员会（2016年7月）的积极建议，因为在接受单剂​​量TG1050的患者中没有观察到严重的不良事件。

这项首次人体试验是一项国际性，随机，多中心，双盲，安慰剂对照研究，评估目前正在接受标准治疗抗病毒治疗的慢性HBV感染患者的TG1050。阶段1 / 1b研究的主要目的是评价以单次和多次剂量施用的TG1050的安全性和耐受性，并确定TG1050施用的进一步发展的剂量和方案。次要目的包括评价TG1050的抗病毒活性和免疫应答。第一次数据读出预计在2017年下半年。

TG1050是基于表达三种HBV抗原的病毒载体用于治疗慢性乙型肝炎的靶向免疫治疗候选物。它是由Transgene的抗病毒研究团队设计和开发的治疗性疫苗。临床前研究结果表明TG1050诱导强大，广泛和长期的HBV特异性T细胞的能力，其特征与感染已被解决的患者相似。还显示了TG1050的抗病毒作用，包括对表面抗原（HBsAg）的血清转化。

慢性乙型肝炎是主要的未满足的医疗需要，因为目前的治疗仅治愈约3％的患者。使用TG1050，Transgene正在寻求提供一种更有效的治疗，这是该病毒性肝病的迫切需要，可导致肝硬化和肝癌。

关于慢性乙型肝炎
乙型肝炎是由HBV感染引起的潜在的危及生命的肝脏感染。它可导致慢性感染和肝脏疾病，如果不加治疗，会使人患肝硬化和肝癌的高死亡风险。最近的数字表明，在美国，德国，法国，意大利，西班牙和英国，慢性乙型肝炎治疗的患者总数为20万，在日本有100,000名患者。合格的中国市场代表50万患者。这些数字预计将增加，因为更多的患者在未来几年被诊断和治疗他们的疾病（来源：ECDC-乙型肝炎的发病率，决定资源：专家意见）。目前可用的抗病毒治疗仅治疗约3％的病例，并且发达国家的患者必须平均接受这些治疗15年，并且通常为其一生。因此，迫切需要开发新的治疗方法以提高治愈率。

关于TG1050
TG1050是基于表达3种HBV抗原的病毒载体用于治疗慢性乙型肝炎的靶向免疫治疗候选物。转基因已经开始了一项随机，多中心，双盲，安慰剂对照的安全性和剂量调查首次研究（NCT02428400），评估目前正在接受慢性HBV感染治疗的患者的TG1050的安全性和耐受性标准治疗抗病毒治疗。 TG1050的技术也在中国开发，目前正在进行SFDA评估，并最近获得了IND编号。在
中国，Transgene与Tasly生物制药技术合资经营。
有关TG1050的最新出版物，请访问：www.transgene.fr。

newchinabok

治疗性疫苗屡战屡败，屡败屡战

MP4

目前正在进行SFDA评估，并最近获得了IND编号。

MP4

老王卖麻花 发表于 2016-10-18 17:43
MP4傻逼，能好好学习不 。不长记性。

SFDA 是啥？ 现在还有么？

原文是这么写的，你要挑骨头找原文啊。
你能好好看看原文不？