ContraVir剂量的第一个主题1B阶段治疗慢性乙型肝炎病毒感染CMX

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ContraVir Doses First Subject in Phase 1b Clinical Study of CMX157 for Treating Chronic Hepatitis B Infection

Company Expects to Commence Dosing Hepatitis B Patients in Phase 2a Clinical Study in 2Q 2016

06:00 ET from ContraVir Pharmaceuticals, Inc.

EDISON, N.J., April 19, 2016 /PRNewswire/ -- ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has dosed the first healthy volunteer in the Phase 1b portion of the Company's Phase 1b/2a multiple ascending dose clinical study of CMX157, ContraVir's novel, highly potent lipid conjugate of tenofovir for treating hepatitis B virus (HBV) infection.

James Sapirstein, CEO of ContraVir, stated, "Dosing the first healthy volunteer in the CMX157 Phase 1b/2a clinical study is a significant milestone.  We're confident this trial will build upon the safety database that was already established in a completed Phase 1 study.  Concurrently we are preparing to launch the Phase 2a portion of our study, which will evaluate the antiviral activity and safety of CMX157 in patients diagnosed with HBV, in the second quarter of 2016."

The Phase 1b portion of the study will enroll 50 healthy volunteers assigned to one of five sequential, ascending CMX157 dosing cohorts.  Participants will receive two weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157 or placebo; eight per cohort receiving CMX157 and two per cohort receiving placebo. The objectives of the study are to evaluate the safety, tolerability and pharmacokinetic profile of CMX157.  Initiation of each higher dose cohort will proceed following review of the data from the previous cohort. An independent review will be conducted by a Data Safety Monitoring Board (DSMB) between the 25 mg and 50 mg cohorts (the midpoint of the Phase 1 portion of the study).

Following this DSMB review, ContraVir plans to initiate the Phase 2a portion of the study in parallel with the continuing Phase 1b portion.  The Phase 2a will enroll 60 treatment-naïve patients with chronic HBV infection to compare CMX157 to tenofovir DF (TDF, marketed by Gilead Sciences as Viread®).  This portion of the study will also consist of a sequential dose escalation, with 10 patients per cohort receiving four weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157, and two patients per cohort receiving 300 mg of TDF, the standard dose of Viread®.  As in the Phase 1b portion of the study, initiation of each higher dose cohort will follow review of the data from the previous cohort and there will be a DSMB review between the 25 mg and 50 mg CMX157 cohorts.

About ContraVir Pharmaceuticals
ContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with two candidates in mid-to-late stage clinical development. ContraVir's lead clinical drug, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is currently in Phase 3 clinical development.  In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study.  ContraVir is also developing CMX157, a highly potent analog of the successful antiviral drug tenofovir for the Hepatitis B virus.  CMX157's novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal and bone side effects.

StephenW

ContraVir剂量的第一个主题1B阶段治疗慢性乙型肝炎病毒感染CMX157的临床研究
公司预计开始剂量乙型肝炎患者在2a期临床研究在2016年第二季度
从ContraVir制药公司ET 06:00
EDISON，NJ，2016年4月19日/新华美通/ - ContraVir制药公司（纳斯达克股票代码：CTRV），一家生物制药公司的发展重点和有针对性的抗病毒疗法的商业化，今天宣布，该公司已经给予了第一健康志愿者CMX157，ContraVir新颖，用于治疗乙型肝炎病毒（HBV）感染的替诺福韦强效脂结合本公司的阶段1B / 2A多剂量递增临床研究阶段1B部分。
詹姆斯Sapirstein，ContraVir首席执行官表示，“加药在CMX157阶段1b / 2A临床研究的第一个健康志愿者是一个显著的里程碑。我们相信这一试验将建立在一个已经建立在完成第一阶段的安全数据库研究。同时，我们正在准备推出我们研究的2a期部分，将评估诊断为乙肝患者的抗病毒活性，CMX157的安全性，在2016年第二季度“
这项研究的1b期部分将招收分配到五个连续的一个50名健康志愿者，升CMX157计量同伙。参与者将接收每日一次剂量两周或5，10，25，50或100mg CMX157或安慰剂;八至队列接收CMX157和2％的队列接受安慰剂。该研究的目的是评估CMX157的安全性，耐受性和药代动力学曲线。每个高剂量组的启动将进行以下从以前的队列中的数据进行审查。一个独立审查将由25毫克和50毫克的人群（研究的1期部分的中点）之间的数据安全监督委员会（DSMB）进行。
在此之后，DSMB的综述，ContraVir计划与持续阶段1b部，以启动研究的2a期部分中平行。 2a期将招收60初治慢性HBV感染比较CMX157替诺福韦DF（TDF，由Gilead Sciences公司销售作为Viread®）。该研究的这一部分也将包括一个连续的剂量递增的，每个队列接收每日一次剂量或5，10，25，50或100mg CMX157的，并且每个队列两名患者接受300的四周10例TDF的毫克，Viread®的标准剂量。如在研究的阶段1b部，每一较高剂量群组的起始将跟随数据的审查从以前的队列并会有25毫克和50毫克CMX157同伙之间DSMB审查。
关于ContraVir制药
ContraVir是一家生物制药公司，专注于开发和有针对性的抗病毒治疗的商品化与两位候选人在中期到后期临床开发。 ContraVir的首席临床用药，FV-100，是被用于治疗带状疱疹，带状疱疹，这是目前正处于三期临床开发研制的口服核苷类似物前体药物。除了直接的抗病毒活性，FV-100已经证明，以降低在2期临床研究衰弱称为带状疱疹后神经痛（PHN）带状疱疹相关疼痛的发病率的可能性。 ContraVir也在开发CMX157，成功抗病毒药物泰诺福韦为乙型肝炎病毒的高度有效的类似物。 CMX157的新颖结构导致替诺福韦降低循环水平，降低全身暴露，从而减少对肾和骨的副作用的潜力。