IDX184 has been placed on partial clinical hold by FDA

StephenW

                                       August 16, 2012
                                                                     
                                            Idenix Provides Update on IDX184 Clinical Development Program

IDX184 has been placed on partial clinical hold by FDA

Management to host a conference call webcast today at 8:30 am ET

CAMBRIDGE, Mass., Aug. 16, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the Company received verbal notice from the U.S. Food and Drug Administration (FDA) that a partial clinical hold has been placed on IDX184, the Company's nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus (HCV).
As a result of the recent occurrence of a serious cardiac-related adverse event encountered with a competitor's nucleotide polymerase inhibitor for the treatment of HCV, the FDA has expressed an interest in further reviewing the safety of IDX184 and has placed IDX184 on partial clinical hold. In previous clinical trials as well as the ongoing phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV), there has been no evidence to date of cardiotoxicity in patients dosed with IDX184 with PegIFN/RBV beyond that seen with PegIFN/RBV alone. There are currently no patients receiving IDX184 worldwide.
The FDA has requested additional data on patients treated with IDX184. Patient safety is our main concern and Idenix will immediately begin work to comply with the FDA request and expects to submit these data to the FDA in the coming weeks. The Company intends to have an ongoing discussion with the FDA following the submission of this data.
ABOUT IDX184
IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. The Company reported interim data in June 2012 for the first cohort of 31 patients from an ongoing phase IIb clinical trial of IDX184 in combination with PegIFN/RBV. Of the patients who achieved an extended rapid virologic response (undetectable levels of virus at 4 weeks and 12 weeks) and completed an additional 12 weeks of PegIFN/RBV (n=9), 100% of patients (4/4) in the 100 mg arm and 80% of patients (4/5) in the 50 mg arm achieved a sustained virologic response four weeks after the completion of treatment (SVR4).
In July 2012, an independent data safety monitoring board reviewed the safety data for this study and confirmed that the side effect profile of IDX184 combined with PegIFN/RBV is consistent with that of PegIFN/RBV alone.
ABOUT PARTIAL CLINICAL HOLD
A partial clinical hold is a delay or suspension of only part of the clinical work requested under the investigational new drug (IND) application (e.g., a specific protocol or part of a protocol is not allowed to proceed; however, other protocols or parts of the protocol are allowed to proceed under the IND). Under the partial clinical hold, Idenix cannot enroll patients into additional clinical trials until agreement is reached with the FDA on the next clinical trial design.

StephenW

2012年8月16日
Idenix公司提供在IDX184临床开发计划的更新


IDX184一直放在部分临床持有的由FDA


马萨诸塞州剑桥，8月16日，2012年（中国商业电讯） - 一家生物制药公司从事药物发现和开发治疗人类病毒性疾病，Idenix公司制药公司（纳斯达克：IDIX），今天宣布，公司收到美国食品和药物管理局（FDA）已IDX184放在口头通知，部分临床保持，该公司正在开发用于治疗丙型肝炎病毒（HCV）的核苷酸聚合酶抑制剂。

的1严重的心脏相关的不良竞争对手的治疗丙型肝炎病毒核苷酸聚合酶抑制剂遇到的事件最近发生的结果，FDA的已表示有意进一步审查的IDX184的安全，并已放置部分临床保持IDX184。在以前的临床试验以及的IDX184正在进行的IIb期临床试验结合聚乙二醇干扰素和利巴韦林（PegIFN /利巴韦林），一直没有证据PegIFN /利巴韦林IDX184剂量超出看到与患者的心脏至今PegIFN /利巴韦林单。目前没有接受IDX184全球。

FDA已经要求额外的数据与IDX184治疗的患者。病人的安全是我们的主要关切和Idenix公司将立即开始工作，以符合FDA的要求，并预计在未来几周内提交这些数据给FDA。该公司打算与FDA正在进行的讨论后，提交该数据。

关于IDX184

IDX184是一个unpartnered，新颖，有针对性的肝，其中包括Idenix公司的专有技术肝靶向的2'-甲基鸟嘌呤核苷酸的前体药物。这项技术使核苷磷酸运送到肝脏，导致形成的核苷三磷酸水平高，有可能最大限度地提高药物的疗效和全身副作用低，每天服用一次的限制。该公司公布了首批为31例患者的IDX184正在进行的IIb期临床试验PegIFN /利巴韦林联合在2012年6月的中期数据。的患者达到扩展快速病毒学应答（病毒检测不到的水平在第4周和12周），并完成额外PegIFN /利巴韦林12周组（n = 9），100％的患者（4/4）在100四个星期后完成治疗（SVR4的）毫克手臂和80％的患者在50毫克臂（4/5）实现了持续病毒学应答。

2012年7月，一个独立的数据安全监测委员会审查这项研究的安全数据证实，结合PegIFN /利巴韦林副作用的IDX184 PegIFN /利巴韦林单是一致的。

关于部分临床控股

部分临床保持只要求下的研究性新药（IND）的申请（例如，一个特定的协议或协议的一部分，不允许进行的临床工作的一部分延迟或暂停;然而，其他协议或零件该协议允许进行下IND）。 Idenix公司下的局部临床搁置，无法招收到更多的临床试验病人直到未来的临床试验设计与FDA达成的协议。