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标题: 与Viread®用于治疗乙型肝炎CMX157的ContraVir同修头对头2a期临床 [打印本页]

作者: StephenW 时间: 2016-6-2 15:49 标题: 与Viread®用于治疗乙型肝炎CMX157的ContraVir同修头对头2a期临床

ContraVir Initiates Head-to-Head Phase 2a Clinical Study of CMX157 vs. Viread® for Treating Hepatitis B

First Study to Evaluate the Antiviral Power of CMX157 Compared to the Current Standard of Care in Hepatitis B

Jun 01, 2016, 06:00 ET from ContraVir Pharmaceuticals, Inc.

EDISON, N.J., June 1, 2016 /PRNewswire/ -- ContraVir Pharmaceuticals, Inc. (NASDAQ: [url=]CTRV[/url]), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that following a positive recommendation from an independent Data Safety Monitoring Board (DSMB), the Company has begun screening patients with chronic hepatitis B (HBV) for enrollment in a head-to-head Phase 2a study comparing ContraVir's CMX157 to tenofovir DF (TDF, marketed by Gilead Sciences as Viread®). The study will compare sequentially escalating doses of CMX157, beginning at a 5 mg daily CMX157 dose compared to 300 mg daily dose of TDF which is the standard daily dose of Viread®. The study is expected to conclude in the fourth quarter of 2016.

The DSMB conducted an independent review of the safety, tolerability and pharmacokinetic profile of CMX157 from the three completed dosing groups of ContraVir's ongoing Phase 1b safety study in healthy volunteers. In addition to recommending initiation of the Phase 2a study, the DSMB also recommended continuation of the Phase 1b, which is now past its midpoint with the final two dosing groups (50 and 100 mg) remaining.

"This is a significant inflection point for ContraVir, as the Phase 2a study we've just commenced will be the first evaluation of the antiviral activity of CMX157 compared to Viread in hepatitis B patients," said James Sapirstein, CEO of ContraVir. "We're highly encouraged by the pharmacokinetic profile demonstrated so far in the Phase 1b study, which showed detectable CMX157 levels at 5 mg once daily, the lowest dose tested. Considering our animal data showing a high degree of liver targeting and laboratory data showing superior potency of CMX157 against HBV in vitro, these preliminary results suggest the potential of CMX157 to be dosed lower than Viread, and at the same or lower dose than tenofovir alafenamide, Gilead's 'TAF'. We look forward to dosing the first HBV patients in this study and to reporting the data as we advance through the different dosing groups."

The Phase 2a trial will enroll 60 treatment-naïve patients with chronic HBV infection. This study will 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, plus two patients per cohort receiving 300 mg of TDF, the standard dose of Viread. As in the Phase 1b study, initiation of each higher dose cohort will follow review of the data from the previous cohort, and there will be another DSMB review between the 25 mg and 50 mg CMX157 cohorts. Final results from this study are expected in the fourth quarter of 2016.

作者: StephenW 时间: 2016-6-2 15:49

与Viread®用于治疗乙型肝炎CMX157的ContraVir同修头对头2a期临床研究

首次研究评价CMX157的抗病毒动力治疗相比在乙肝现行标准

2016年6月1日，从ContraVir制药公司ET 06:00

EDISON，NJ，2016年6月1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，继起一个独立的数据安全和积极的建议监督委员会（DSMB），该公司已开始筛选患者慢性乙型肝炎（HBV）入学的头 - 头2a期研究，比较ContraVir的CMX157替诺福韦DF（TDF，由Gilead Sciences公司销售作为Viread®）。该研究将比较顺序递增剂量CMX157，相对于300毫克的每日剂量TDF的是Viread®标准的每日剂量在5毫克，每日剂量CMX157开始。该研究预计于2016年第四季度结束。

该DSMB进行从健康志愿者ContraVir正在进行的阶段1b安全性研究的三个完成给药组CMX157的安全性，耐受性和药动学特征进行独立审查。除了建议2a期研究开始时，DSMB还建议1b期，现在是过去的中点与最后两个给药组（50至100毫克），其余的延续。

“这是一个ContraVir显著的拐点，因为我们刚刚开始将在乙肝患者相比，Viread的CMX157的抗病毒活性的第一次评估2a期研究中，”ContraVir的首席执行官James Sapirstein说。 “我们高度评价在阶段1b研究迄今表现出的药代动力学特性，这在5毫克显示检测到的CMX157的水平，每天一次，最低的测试剂量鼓励。考虑到我们的动物实验数据表现出高度的肝靶向和实验室数据显示体外CMX157的卓越效能抗HBV，这些初步结果表明比Viread的被给予较低的CMX157的潜力，并在相同或更低的剂量比替诺福韦alafenamide，Gilead公司的“TAF”。我们期待着加药的第一个乙肝患者本研究和报告的数据，我们通过不同的剂量组前进“。

2a期试验将招募60初治慢性HBV感染。本研究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的任一5，10，25，50或100mg CMX157，加上每队列接收300毫克TDF的两名患者四周10例，标准剂量Viread的的。如在阶段1b的研究中，每个较高剂量群组的起始将跟随数据的审查从以前的队列中，并且将有25毫克和50毫克CMX157同伙之间的另一DSMB审查。这项研究的最终结果预计将在2016年第四季度完成。

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