2011年2月7日星期一
AstraZeneca and Targacept, Inc. today announced the enrolment of the first patient in the Phase IIb clinical trial of TC-5214, a nicotinic channel blocker, as a “switch” monotherapy treatment for patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant therapy. This study is in addition to the companies’ Phase III RENAISSANCE programme for TC-5214 as an adjunctive treatment for MDD. The RENAISSANCE programme is designed to support a New Drug Application (NDA) filing in the US planned for the second half of 2012 and a Marketing Authorisation Application (MAA) filing in Europe planned for 2015. AstraZeneca and Targacept are co-developing TC-5214.
在IIB期研究中，基于预定义的标准，MDD患者对使用六种常用SSRI或SNRI抗抑郁药之一的初始打开标签治疗做出反应，以接收两种固定剂量的TC-5214之一，主动控制杜洛西汀或安慰剂。在这项研究的这一双盲阶段中的剂量为每天两次，持续八周。该研究的主要结果度量是与安慰剂相比，TC-5214在蒙哥马利 - 奥斯伯格抑郁量表（MADR）的剂量期结束时的双盲基线变化。该研究预计将使大约有350名患者进入全球约75个中心的双盲阶段。
NOTES TO EDITORS
About TC-5214
最近的科学证据表明，抑郁症状与神经元素受体（NNR）和大脑中其他受受体的过度刺激有关，这些受体被神经递质乙酰胆碱激活。这种过度刺激被称为胆碱能张力的增加。TC-5214调节某些NNR的活性，据信这有助于使胆碱能张力正常化，从而产生抗抑郁作用。
2010年，阿斯利欧洲杯微信买球康和Targacept启动了文艺复兴计划，这是一组III期双盲，安慰剂对照研究，旨在评估TC-5214作为辅助治疗的MDD患者的安全性和功效，这些患者对未对初始治疗进行反应的患者进行初始治疗，SSRI或SNRI。该计划还包括一项长期安全研究，其中患者接受TC-5214或安慰剂长达一年。III期辅助计划的研究设计从TARGACEPT进行的TC-5214阳性IIB临床试验中大量借用。
关于阿斯利康和Targacept之间的合作协议欧洲杯微信买球
In December 2009, AstraZeneca and Targacept signed a collaboration and license agreement for the global development and commercialisation of TC-5214. The initial goal for the collaboration is to develop TC-5214 as an adjunct treatment for MDD in patients with an inadequate response to an SSRI or SNRI to regulatory approval.
关于重度抑郁症
Major Depressive Disorder (MDD) is a highly prevalent and debilitating disease with significant unmet need, affecting approximately 42 million people worldwide, and the global antidepressant market is estimated to be approximately $20 billion today. SSRIs and SNRIs are the most commonly prescribed classes of drugs for depression, but in many cases patients fail to respond adequately. In the NIMH’s large-scale STAR*D study conducted between 2001 and 2006, approximately 63% of patients did not achieve remission with first-line treatment with the SSRI citalopram hydrobromide.
关于Targacept
Targacept正在开发各种创新的NNR Therapeutics™，用于难以治疗的神经系统疾病和疾病。NNR治疗剂选择性调节特定神经元烟碱受体的活性，这是一种独特的蛋白质，可调节各种疾病状态下受损的重要生物学功能。Targacept的铅计划TC-5214正在与阿斯利康共同开发，并正在3阶段临床试验中作为重度抑郁症的辅助治疗。欧洲杯微信买球Targacept利用其科学领导力和专有药物发现平台Pentad™来生成新颖的小分子产品候选者来推动其管道并吸引与全球制药公司的重要合作。有关更多信息，请访问www.targacept.com
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit:www.欧洲杯微信买球astrazeneca.com
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