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发表于 2018-8-7 12:45 |只看该作者 |倒序浏览 |打印
ContraVir Pharmaceuticals Provides an Update to Corporate Objectives
By GlobeNewswire,  August 06, 2018, 03:30:00 PM EDT



EDISON, N.J., Aug. 06, 2018 (GLOBE NEWSWIRE) -- ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of therapeutic drugs for the treatment of hepatitis B virus (HBV), announced an update on its business activities to date.

"2018 has brought a plethora of positive and exciting announcements placing ContraVir as one of the few companies with two clinical assets fighting against the hepatitis B virus," said James Sapirstein, Chief Executive Officer at ContraVir. "Our team has been working diligently to hit anticipated milestones and accelerate the development of our programs. We are incredibly proud of the success we've achieved in such a short period of time and we look forward to additional successes and positive newsflow in the months to come."

Clinical Pipeline Update

    TXL™

    ContraVir previously announced it is ready to initiate the dosing of HBV patients in a dose-ranging study with an optimized formulation of TXL™ to allow for more efficient, predictable and precise delivery while reducing drug burden and maintaining consistent efficacy. The objective of the next clinical trial with TXL™ will be to characterize the pharmacokinetic profile of the new formulation in HBV patients, and to select the target dose to be advanced into a Phase 3 registration clinical development program.  

    CRV431

    A recent update was provided on the progress of the Phase 1/2a study of CRV431. Preliminary data from the first cohort demonstrate positive safety and pharmacokinetic (PK) profile for oral dosing in healthy volunteers.

"Several abstracts have been submitted for presentation at an upcoming scientific conference later this year," said James Sapirstein. "We intend to disclose additional detailed clinical findings from our conducted studies at the conference."

Partnership Update

    As any biotech company, ContraVir will continue to assess strategic alternatives to assist in the research and funding for advancement of its two clinical programs. The company continues to carry discussions with potential partners both in the U.S. and internationally. While there are no guarantees for a partnership deal to come to fruition, ContraVir remains hopeful in finding the right partner who will have a shared commitment in the search for an HBV cure. Operational performance and shareholder value continue to be the management's focus and will strongly influence all decisions going forward.

Financial and Corporate Update

    In the last six months ContraVir raised approximately $13M dollars in proceeds strengthening the company's balance sheet. The financings included $2 million from a securities purchase agreement with Iliad Research and Trading and $10.8 million from a fully marketed rights offering with Maxim Group.

About ContraVir Pharmaceuticals

ContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with a specific focus on developing a potentially curative oral therapy for hepatitis B virus (HBV). The company is developing two novel anti-HBV compounds with complementary mechanisms of action. TXL™, a direct acting antiviral (DAA) nucleotide analog lipid prodrug of tenofovir (TFV), is designed to deliver higher hepatic intracellular concentrations of the active tenofovir species (tenofovir diphosphate) while reducing concentrations of tenofovir outside the liver, causing fewer off-target toxicities and side-effects. CRV431, the other anti-HBV compound, is a host-targeting antiviral (HTA) next-generation cyclophilin inhibitor with a novel chemical structure that optimizes the selective index against HBV. In vitro and in vivo studies have thus far demonstrated that CRV431 reduces HBV DNA and other viral proteins, including surface antigen (HBsAg), while offering additional benefits to mitigate liver disease. For more information, please visit www.contravir.com.

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发表于 2018-8-7 12:45 |只看该作者
ContraVir Pharmaceuticals提供企业目标的更新
作者:GlobeNewswire,2018年8月6日,美国东部夏令时03:30:00



EDISON,新泽西州,2018年8月6日(全球新闻) - ContraVir Pharmaceuticals,Inc。(纳斯达克股票代码:CTRV),一家专注于治疗乙型肝炎病毒(HBV)治疗药物开发和商业化的生物制药公司,宣布迄今为止其业务活动的最新情况。

ContraVir首席执行官James Sapirstein表示,“2018年带来了大量积极而令人兴奋的公告,将ContraVir列为少数几家拥有两种抗乙肝病毒临床资产的公司之一。” “我们的团队一直在努力工作,以达到预期的里程碑,加快我们计划的发展。我们为在短时间内取得的成功感到无比自豪,我们期待在这几个月取得更多成功和积极的新闻流来吧。“

临床管道更新

    通心络™

    ContraVir之前宣布,它准备在剂量范围的研究中启动HBV患者的剂量,并使用优化的TXL™配方,以实现更高效,可预测和精确的分娩,同时减少药物负担并保持一致的疗效。下一次TXL™临床试验的目的是表征新配方在HBV患者中的药代动力学特征,并选择目标剂量进入3期注册临床开发计划。

    CRV431

    最近提供了关于CRV431的第1 / 2a期研究进展的最新情况。来自第一组的初步数据证明了健康志愿者口服给药的阳性安全性和药代动力学(PK)曲线。

“今年晚些时候即将举行的科学会议上已经提交了几份摘要,”詹姆斯萨皮尔斯坦说。 “我们打算在会议上披露我们进行的研究的其他详细临床发现。”

伙伴关系更新

    作为任何生物技术公司,ContraVir将继续评估战略选择,以协助研究和资助推进其两个临床计划。该公司继续与美国和国际上的潜在合作伙伴进行讨论。虽然不能保证合作协议能够实现,但ContraVir仍然希望找到合适的合作伙伴,他们将共同致力于寻求HBV治疗。经营业绩和股东价值仍然是管理层的重点,并将对未来的所有决策产生重大影响。

财务和公司更新

    在过去六个月中,ContraVir筹集了大约1300万美元的收益,加强了公司的资产负债表。融资包括与伊利亚特研究和贸易部签订的证券购买协议中的200万美元以及与Maxim集团完全上市的权利发行中的1,080万美元。

关于ContraVir制药公司

ContraVir是一家生物制药公司,专注于靶向抗病毒治疗的开发和商业化,特别注重开发一种可能治愈的乙型肝炎病毒(HBV)口服疗法。该公司正在开发两种具有互补作用机制的新型抗HBV化合物。 TXL™是替诺福韦(TFV)的直接作用抗病毒(DAA)核苷酸类似物脂质前体药物,旨在提供活性替诺福韦物种(替诺福韦二磷酸)的更高肝细胞内浓度,同时降低肝脏外的替诺福韦浓度,从而减少关闭目标毒性和副作用。 CRV431是另一种抗HBV化合物,是一种宿主靶向抗病毒(HTA)新一代亲环蛋白抑制剂,具有新的化学结构,可优化HBV的选择性指数。到目前为止,体外和体内研究已证明CRV431可降低HBV DNA和其他病毒蛋白,包括表面抗原(HBsAg),同时为减轻肝脏疾病提供额外的益处。欲了解更多信息,请访问www.contravir.com

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发表于 2018-8-8 12:11 |只看该作者
有资料显示,TXL的抗病毒活性是现有的TAF的4.5倍。
剂量和毒副作用,不知道比TAF相比较如何?

如果能进入和通过3期临床,将是口服抗病毒核苷药的又一种选择。
但遗憾,可能依然对cccDNA作用不大,
将来可以作为联合用药的其中之一。

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发表于 2018-8-8 12:19 |只看该作者
CRV431能降低表面抗原,这慢性乙肝功能性治愈的基础。
清除表面抗原,即被视为慢性乙肝的功能性治愈。
研发进度是慢了些
这家公司看来不大,但乙肝药研发还是值得注意

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发表于 2018-8-8 22:21 |只看该作者
不错

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发表于 2018-8-8 22:22 |只看该作者
选择目标剂量进入3期注册临床开发计划。
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