ck公司今天发布年报中期报表，其中。。。

风林 · 发表于 2013-8-1 21:51:14

ck公司31日发布年报中期报表，其中有段关于ck2017357药的，下面是我用有道翻译的，不是很准确，希望有高手翻译一下！
Skeletal Muscle Contractility

tirasemtiv

We are conducting BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) at over 70 sites across the United States, Canada and several European countries. To date, we have enrolled over 500 patients in BENEFIT-ALS. Cytokinetics recently announced that it had been informed by its data management vendor that a programming error in the electronic data capture system controlling study drug assignment for the on-going BENEFIT-ALS clinical trial caused 58 patients initially randomized to and treated with tirasemtiv to receive placebo instead at a certain study visit and for the remainder of the study. No patients randomized to placebo were dispensed incorrect treatment. Cytokinetics and all clinical trial personnel remain blinded to the specific patients affected by the error. Following detection of the error, the company took steps to ensure that no further incorrect study drug assignments occurred and to correct the programming error in the electronic data capture system controlling study drug assignment. In addition, we convened an ad hoc meeting of the study’s Data Safety Monitoring Board (DSMB) to assess whether the error in dispensing study drug had impacted the safety of the 58 affected patients. After review of the relevant safety data from BENEFIT-ALS, the DSMB reported no concerns regarding patient safety.
Following interactions with regulatory authorities, Cytokinetics amended the protocol for BENEFIT-ALS to enable increased enrollment to approximately 680 patients and to update the statistical methods section, in both cases with the objective to maintain the originally intended statistical power of the trial.

CK-2127107

During the quarter, Cytokinetics continued to enroll patients in CY 5011, a first-time-in-humans, Phase I clinical trial of CK-2127107, a novel small molecule activator of the fast skeletal muscle troponin complex, in healthy male volunteers. CY 5011 is a double-blind, randomized, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of single ascending oral doses of CK-2127107 administered in a three-period crossover design.

Pre-Clinical Research

During the quarter, Cytokinetics continued to conduct research under our joint research program with Amgen directed to the discovery of next-generation cardiac sarcomere activators. In addition, the company continued research activities directed to other muscle biology programs.
In June, Cytokinetics announced the publication of three peer-reviewed manuscripts co-authored by company scientists and a group led by Dr. Henk Granzier, Professor of Physiology, and Norville Endowed Chair, Molecular Cardiovascular Research Program, University of Arizona. These publications describe translational research conducted by Dr. Granzier’s laboratory in collaboration with Cytokinetics in which the effects of fast skeletal muscle troponin activation were explored in nemaline myopathy, a rare, sarcomere-based disease.
有道翻译如下
tirasemtiv

我们正在进行利益ALS(盲法评价神经肌肉效果和功能改进与Tirasemtiv在ALS)超过70个网站在美国、加拿大和一些欧洲国家。到目前为止,我们已经登记了500名患者在肌萎缩性脊髓侧索硬化症受益。Cytokinetics最近宣布,它已被告知,其数据管理供应商,编程误差在电子数据采集系统控制研究药物分配利益als正在进行的临床试验病人最初随机造成58和治疗tirasemtiv接受安慰剂相反在特定研究访问和剩余部分的研究。没有病人随机安慰剂是不正确的治疗配药。Cytokinetics和所有临床试验人员仍然看不到具体病人受误差。以下检测错误,公司采取措施确保没有进一步研究药物分配发生错误和纠正错误的编程在电子数据采集系统控制研究药物分配。此外,我们召开了一次特别会议,研究年代数据安全监测委员会(此次)来评估错误是否在配药研究药物有影响的安全影响患者58。在回顾相关的安全数据从效益als,此次报告没有问题关于患者安全。
以下互动与监管部门、Cytokinetics修改的协议,使扩招受益als对大约680病人和更新统计方法部分,在这两种情况下的目标在维持原先预定的统计力量的审判。

ck - 2127107
在这一季度,Cytokinetics继续招收患者5011,CY首次在人类,第一阶段临床试验的ck - 2127107,一个新颖的小分子催化剂的快速骨骼肌肌钙蛋白复杂,在健康男性志愿者。CY 5011是一个双盲,随机,安慰剂对照研究旨在评估安全、耐受性和药代动力学的单身提升口服一定剂量的ck - 2127107在三个时期管理交叉设计。

临床前研究
在这一季度,Cytokinetics继续进行研究在我们的联合研究项目,安进公司针对发现的下一代心肌节活化剂。此外,该公司继续研究活动指向其他肌肉生物程序。
今年6月,Cytokinetics宣布出版三个同行评议的手稿撰写公司牵头的一个集团的科学家和博士,教授Granzier Henk生理学,Norville赋予椅��,分子心血管研究计划,亚利桑那大学。[color=rgb(0,0,0) !important]这些出版物描述转化进行的研究年代Granzier博士实验室合作的Cytokinetics影响骨骼肌肌钙蛋白的快速激活了在nemaline肌病,一种罕见的疾病,肌节的基础。