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TetraLogic暂时停了birinapant乙肝试验注册;股暴跌   [复制链接]

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发表于 2015-5-7 00:14 |只看该作者 |倒序浏览 |打印
本帖最后由 StephenW 于 2015-5-7 04:33 编辑

                TetraLogic stops enrollment in birinapant hep B trial; shares plummet                                                                                  May  6 2015, 10:48 ET | About: TetraLogic Pharmaceuti... (TLOG) | By: Douglas W. House, SA News Editor
                  
               
              
                                                         
  • TetraLogic Pharmaceuticals (TLOG -59%) haltspatient enrollment in a Phase 1 ascending dose trial of its lead product candidate, birinapant, in patients with chronic hepatitis B infection due to cranial nerve palsies observed in the first cohort. No additional details are provided.
  • Birinapantis also being investigated for the potential treatment of multiple cancers. It is an SMAC-mimetic that binds to proteins called Inhibitor of Apoptosis proteins, or IAPs, that suppress apoptosis (cell death). SMAC, Second Mitochondrial Activator of Caspases, is a naturally occurring IAP inhibitor. Cancer cells and cells infected with certain viruses (hep B) have apoptosis-escaping characteristics. Inhibiting the mechanisms that enable rogue cells to avoid cell death increases apoptosis and potentially delivers a therapeutic benefit.
        

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发表于 2015-5-7 00:14 |只看该作者
TetraLogic停在birinapant乙肝试验注册;股暴跌
2015年5月6日,10:48 ET |关于:TetraLogic Pharmaceuti ...(TLOG)|通过:道格拉斯W.房子,SA新闻编辑[联系这个编辑器评论或新闻提示]

    TetraLogic制药(TLOG -59%)的患者停止招生在其先导候选产品,birinapant的第1阶段剂量递增试验,慢性乙肝病毒感染,由于在第一批观察颅神经麻痹。没有提供更多细节。
    Birinapant也正在研究用于多种癌症的潜在治疗。这是一个SMAC模拟物的结合蛋白质被称为凋亡抑制蛋白,或单边行动计划,即抑制细胞凋亡(细胞死亡)。 SMAC,胱天蛋白酶的第二线粒体活化剂,是一种天然存在的IAP抑制剂。癌细胞和感染的细胞的某些病毒(乙肝)具有细胞凋亡逃逸特性。抑制,可使流氓细胞,以避免细胞死亡增加凋亡和潜在提供治疗益处的机制。

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发表于 2015-5-7 00:20 |只看该作者
May 6, 2015

TetraLogic Announces Temporary Halt of Chronic Hepatitis B Trial

MALVERN, Pa., May 6, 2015 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG), a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, today announced that it has temporarily halted enrollment in the birinapant chronic hepatitis B multiple ascending dose trial, currently being conducted in Australia, due to cranial nerve palsies observed in the first cohort.

About TetraLogic Pharmaceuticals Corporation

TetraLogic is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases. TetraLogic has two clinical-stage product candidates in development: birinapant and SHAPE. Birinapant is currently being tested in Phase 1 and Phase 2 clinical trials for hematological malignancies and solid tumors, and is also being tested in a Phase 1b/2a clinical trial in hepatitis B. SHAPE is currently being tested in a Phase 2 clinical trial for early-stage cutaneous T‑cell lymphoma.

Forward Looking Statements

Some of the statements in this release are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events or TetraLogic's pre-clinical and clinical development of birinapant, SHAPE and other clinical programs, future expectations, plans and prospects. Although TetraLogic believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. TetraLogic has attempted to identify forward looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in our Annual Report on Form 10-K filed with the SEC on February 26, 2015. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT: Pete A. Meyers

         Chief Financial Officer and Treasurer

         TetraLogic Pharmaceuticals Corporation

         (610) 889-9900, x103

         [email protected]

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发表于 2015-5-7 00:21 |只看该作者

2015年5月6日
先前版本
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TetraLogic宣布慢性乙型肝炎审判暂时停止

宾夕法尼亚,MALVERN,2015年5月6日(GLOBE NEWSWIRE) - TetraLogic制药公司(纳斯达克股票代码:TLOG),临床阶段的生物制药公司,专注于肿瘤学和传染病发现和开发创新的小分子疗法,今天宣布,它已暂时停止登记在birinapant慢性乙型肝炎多剂量递增试验中,目前在澳大利亚进行的,由于在第一组观察颅神经麻痹。

关于TetraLogic医药有限公司

TetraLogic是临床阶段的生物制药公司,专注于发现和培养肿瘤和感染性疾病的新型小分子疗法。 TetraLogic有两个临床试验阶段的候选产品开发:birinapant和形状。 Birinapant目前正在在阶段1和阶段2为血液恶性肿瘤和实体瘤的临床试验,并且也正在在一个阶段1b / 2a中的临床试验中乙型肝炎形状测试目前正在一个阶段2临床试验早期测试-stage皮肤T细胞淋巴瘤。

前瞻性陈述

一些本新闻稿中的陈述为前瞻性陈述1933年证券法第27A条所指,1934年证券交易法和1995年私人证券诉讼改革法案,其中涉及风险和不确定性的第21E。这些声明与未来事件或TetraLogic的临床前和临床birinapant的发展,形状和其他临床方案,未来预期,计划和前景。虽然TetraLogic认为,这种反映前瞻性陈述中的预期是合理的作为作出之日起,预期可能被证明是从表达或此类前瞻性陈述中所暗示的结果存在重大差异。 TetraLogic试图通过术语包括“来识别前瞻性陈述”认为,''''的估计,''''预期','''希望','''计划,''''项目,''''计划''''势''''也许,''''可能​​','''可能​​','''意志''''应该''''约''或传达不确定性换句话说未来事件或结果来识别这些前瞻性陈述。这些声明仅是预测,涉及已知和未知的风险,不确定性和其他因素,包括表格10-K与美国证券交易委员会提交的2月26日,2015年正向的任何标题下讨论了在我们的年度报告的“风险因素”本新闻稿中包含前瞻性声明仅代表公司当日。我们不承担更新本新闻稿中包含以反映其日后发生的事件或情况,或反映预料之外的事件发生的任何前瞻性陈述。

联系方式:皮特A.迈耶斯

         首席财务官和司库

         TetraLogic医药有限公司

         (610)889-9900,X103

         [email protected]

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发表于 2015-5-7 00:35 |只看该作者
Bell’s palsy (BP) risk, is a known and reversible side effect of SMAC mimetics in cancer trials
贝尔氏麻痹(BP)的风险,是Smac模拟物在癌症临床试验已知的和可逆的副作用


http://meetinglibrary.asco.org/content/115322-132
B-associated toxicity of Bell’s palsy (Grade 2) was considered a DLT (Dose Limiting Toxicities) and noted at higher dose levels for I, D, and LD, but not CP.
This unusual reversible toxicity occurred during cycle 1 in 7 pts. Six of these pts continued therapy without recurrence. PK studies demonstrated no effect of B on CT. Except for CP, CT did not change the PK of B. CP increased plasma PK for B, possibly due to OATP1B3 transporter effects, but without increased B toxicities.

B-相关的贝尔氏麻痹(二级)的毒性被认为是DLT(剂量限制性毒性),并指出在较高剂量水平I,D,和LD,但不是CP。
在周期17分发生这种不寻常的可逆的毒性。这六个点继续治疗无复发。 PK研究显示出B对CT没有影响。除CP,CT没有改变B. CP的PK的增加的血浆PK于B,这可能是由于OATP1B3转运的影响,但不增加乙毒性。

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发表于 2015-5-7 00:36 |只看该作者
?'??试验停止????

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发表于 2015-5-7 00:45 |只看该作者
刚看到

股价暴跌

楼主是否能说说目前对此看法?还能进行吗?

这个消息诡异

因为在美国一期实验已经通过了,哪怕无效也可以理解,怎么这么大副作用??

难道剂量的问题?

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发表于 2015-5-7 00:52 |只看该作者
一期都过了怎么有副作用?

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发表于 2015-5-7 00:56 |只看该作者
太诡异了,前几天刚增发新股

一期的问题得到一个解答

癌症一期标准不同,相对宽松,因为这个救命药,所以副作用大无所谓

乙肝相对严格

不知道对不对

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发表于 2015-5-7 01:03 |只看该作者
晴天霹雳

还是要淡定
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