2014-10-21国内、国际新药临床信息汇总

Celgene公布克罗恩病反义核酸药物Mongersen惊人II期疗效数据

                               
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发布日期：2014-10-21  来源：新药汇  浏览次数：5

26亿美元投资的口服反义核酸药物Mongersen，将为克罗恩病的临床治疗带来一场革命。

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在研发阶段就将潜力品种收入囊中，是许多大中型药企惯用的招数，这考验的不仅是财力，更考验眼力。今年4月，生物技术巨头新基（Celgene）就与名不见经传的爱尔兰生物技术公司Nogra制药公司签署了一笔高达26亿美元的协议，在支付了7.1亿美金预付款后，将一种处于II期临床的克罗恩病（Crohn's disease，CD）口服反义核酸药物Mongersen（GED-0301）收入囊中。业界认为，Celgene的这一豪赌要么使其成为这一行业最大的赢家，要么成为最大的输家。

近日，Celgene公布了Mongersen为什么值得豪赌的理由。Celgene表示，该药在II期临床中所表现出的惊人疗效，将为克罗恩病的临床治疗带来一场革命。

Mongersen（GED-0301）是一种首创的口服反义寡核苷酸疗法，开发用于中度至重度克罗恩病的治疗。目前，Mongersen已顺利通过一项涉及166例克罗恩病患者的II期研究，而Celgene已迫不及待地计划在今年年底启动Mongersen的III期临床项目。

该项II期临床研究在166例活动性克罗恩病患者中开展，调查了口服反义药物Mongersen的疗效和安全性。数据表明，与安慰剂相比，2种剂量Mongersen治疗组均有显著更高比例的患者实现临床缓解，40mg/天剂量组、160mg/天剂量组、安慰剂组实现临床缓解的患者比例分别为55.0%、65.1%、9.5%，2个治疗组与安慰剂组相比数据均具有统计学显著差异（p＜0.0001）；10mg/天剂量组与安慰剂组在临床缓解上无显著差异（12.2% vs 9.5%）。与安慰剂组（临床反应率=16.7%）相比，3种剂量Mongersen治疗组临床反应率显著更高：10mg/天剂量组（36.6%，p=0.039）、40mg/天剂量组（57.5%，p＜0.0001）、160mg/天剂量组（72.1%，p＜0.0001）。不良事件（AEs）和严重不良事件（SAEs）发生率在各个治疗组相似。

今年4月，Celgene与Nogra签订协议，根据协议条款，Celgene将支付7.1亿美元的预付款。若GED-0301研发成功，Nogra公司将有资格获得超过8.15亿美元的开发里程碑款，若GED-0301上市后的年销售额超过40亿美元，Nogra还将获得11亿美元的销售里程碑款，使得该笔交易的最大价值达到了26亿美元。

Mongersen是一种口服反义药物，是一种合成的寡核苷酸，开发用于中度至重度克罗恩病的治疗，Mongersen靶向Smad7信使RNA（mRNA），通过结合Smad7 mRNA，关闭基因的表达，从而降低Smad7的蛋白水平。在克罗恩病患者中，异常高水平的Smad7蛋白干扰了肠道中TGF-β1抗炎信号通路，导致炎症的增加。Mongersen药片的独特配方，被设计为在小肠的远端（末端回肠）和邻近结肠末端（右半结肠），在该部位局部起效，降低Smad7蛋白水平。

英文原文：Celgene's $2.6B deal for Crohn's drug pays off with promising PhII

Celgene ($CELG) bet big on the little-known Irish biotech Nogra Pharma when it partnered on a mid-stage drug for Crohn's disease. And today Celgene spelled out the reasons why it gambled $710 million upfront on a Phase II drug, highlighting data that support a clear case that the therapy can help spur clinical remission in a broad group of patients.

"Clinical remission was achieved by significantly greater proportions of patients receiving Mongersen (GED-0301) 40 (55.0%) and 160 mg/day (65.1%) compared with placebo (9.5%; p<0.0001 for both)," Celgene noted in an abstract. "No significant difference in clinical remission was seen for 10 mg/day (12.2%) vs. placebo. The rate of clinical response was significantly greater among patients receiving 10 (36.6%), 40 (57.5%) or 160 mg/day (72.1%) of Mongersen vs. placebo (16.7%; p=0.039, p=0.0001 and p<0.0001, respectively). The rates of adverse events (AEs) and serious AEs (SAEs) were similar across groups."

Mongersen is an oral antisense oligonucleotide that is designed to zero in on Smad7 near the end of the colon, wher it can incite an inflammatory response. Celgene had already seen these results when it bought in for the upfront plus $1.9 billion in development and sales milestones. For analysts, who had to adjust their expectations for Celgene after the deal, the numbers helped underscore the potential for this drug.

"Overall, data from the ~160 patient trial (40 per arm) is at the high end of our expectations and perhaps roughly in-line with consensus Street expectations," notes ISI's Mark Schoenebaum. "Thus, my best guess at this point is that the stock will rise modestly today."

"GED-0301, a first-in-class oral antisense therapy, has the potential to change the treatment landscape for Crohn's disease," said Scott Smith, who runs Celgene's inflammation and immunology group. "Celgene is excited to pursue the clinical development program for this novel therapy in phase III trials in the near future."

Celgene is no stranger to the world of biotech deals. The company has one of the most active partnering groups in the industry, and there's a big interest in diversifying the company's product portfolio outside of cancer.

For now, Celgene appears ready to deliver on that promise. Mongersen is slated to start Phase III before the end of this year.

Cytokinetics推动ALS药物tirasemtiv进入三期研究

                               
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发布日期：2014-10-21  来源：生物谷  

今年早些时候，生物制药公司Cytokinetics公司公布了其治疗ALS药物tirasemtiv的中期临床研究数据。目前，公司正着手准备相关数据以说服FDA批准公司进行关于tirasemtiv的临床三期研究。

                               
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ALS全名肌萎缩性脊髓侧索硬化症，是一种发病率极低得罕见病。由于患者全身肌肉萎缩，而造成失去行动能力，严重时甚至肺部等器官功能也受到极大损伤。此前，风靡一时得冰桶挑战就是旨在为这类疾病募集善款。目前市面上治疗此类疾病的药物凤毛麟角。

今年早些时候，生物制药公司Cytokinetics公司公布了其治疗ALS药物tirasemtiv的中期临床研究数据。结果发现，这种药物未能达到其预定终点，即改善患者的行动能力，延缓ALS的发病进程。不过，研究人员分析后认为，tirasemtiv能够明显增大患者的慢肺活量（SVC）指标，即患者每次缓慢深呼吸能够吸入的最大气体量。SVC也被认为是评价ALS病情进程的一个重要指标。此次临床二期研究共有711名ALS患者参加。因此，Cytokinetic公司认为tirasemtiv仍然能够明显改善ALS患者的生存状况。目前，公司正着手准备相关数据以说服FDA批准公司进行关于tirasemtiv的临床三期研究。

然而，这一消息并未明显提振投资者的信心，tirasemtiv的中期研究临床数据刚刚公布时，Cytokinetic公司股价遭受重挫，此次利好消息也仅将股价提升6％，恢复至公司暴跌前的65％左右。显示出市场对tirasemtiv能够获得FDA青睐的疑虑。

最近一段时间，Cytokinetic公司的研发工作频频受挫。去年公司与安进公司开发的治疗心衰药物omecamtiv mecarbil临床二期研究也宣告失败，与此相关的研究数据也在进一步分析中。安进公司表示需要得到最终的分析结果后才会决定omecamtiv mecarbil的未来命运。

详细英文报道：

Earlier this year, Cytokinetics ($CYTK) tanked as its lead prospect, a treatment for amyotrophic lateral sclerosis (ALS), missed its primary endpoint and a slew of secondary goals in a mid-stage trial. But the drug did come through on one measure of lung function, and, upon analysis of the results, the biotech believes that could be its ticket to FDA approval.

The treatment, tirasemtiv, is designed to increase muscle sensitivity to calcium, thereby improving movement and functionality in patients with ALS and delaying the disease's characteristic fatigue. However, in a Phase IIb study dubbed BENEFIT-ALS, Cytokinetics' drug failed to significantly improve patient scores on a standardized measure of ALS symptoms, and it posted mixed results on its secondary goals.

But the 711-patient trial wasn't a total loss, the company said, as tirasemtiv charted a statistically significant benefit on patients' slow vital capacity (SVC), which is a measure of how much air they can exhale slowly after a deep breath. After running statistical analyses and consulting with neuromuscular experts, Cytokinetics is convinced improving SVC is a viable surrogate for improving ALS, and the company is now making that case to the FDA, hoping to kick off a late-stage trial on tirasemtiv next year.

"BENEFIT-ALS is the first clinical trial in patients with ALS to demonstrate a positive and potentially clinically meaningful effect on slow vital capacity, an important measure of disease progression and predictor of survival," CEO Robert Blum said in a statement. "We are encouraged by our initial interactions with the FDA relating to the results of BENEFIT-ALS and believe that our continuing discussions can inform our plans to pursue a potential registration program based on effects observed on respiratory function measured by slow vital capacity in patients with ALS."

Investors, however, would seem to be less than optimistic that the FDA will get behind the plan and sign off on SVC as a primary endpoint in Phase III. The latest news sent Cytokinetics' shares up about 6% on Monday, gains that hardly reverse the 65% dive the biotech took after first reporting its Phase IIb results.

Tirasemtiv's mid-stage misstep came on the heels of a setback for Cytokinetics' other lead program, the Amgen ($AMGN)-partnered heart failure treatment omecamtiv mecarbil. An intravenous formulation of the drug failed in Phase IIb, Amgen disclosed last year, and now the Big Biotech is waiting on data from a mid-stage study on an oral version before deciding whether to head into Phase III or scrap the program.

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欧盟批准强生/Pharmacyclics抗癌药Imbruvica（ibrutinib）治疗2种血癌

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发布日期：2014-10-21  来源：生物谷

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强生（JNJ）及合作伙伴Pharmacyclics制药公司近日联合宣布，抗癌药Imbruvica（ibrutinib）获欧盟委员会（EC）批准，用于2种血液癌症。

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# D+ \9 @& ]  U# F* U1 n    强生（JNJ）及合作伙伴Pharmacyclics制药公司近日联合宣布，抗癌药Imbruvica（ibrutinib）获欧盟委员会（EC）批准，用于2种血液癌症：（1）用于复发性或难治性套细胞淋巴瘤（MCL）成人患者的治疗；（2）用于既往接受过至少一种疗法的慢性淋巴细胞白血病（CLL）成人患者的治疗；（3）用于携带del 17p删除突变或TP53突变且不适合化疗-免疫疗法的慢性淋巴细胞白血病（CLL）成人患者的一线治疗。业界此前预计，Imbruvica的年销售额峰值将突破50亿美元。

Imbruvica的获批，是基于在CLL患者中开展的III期RESONATE（PCYC-1112-CA）研究和Ib/II期研究(PCYC-1102)以及在MCL患者中开展的II期研究（PCYC-1104）的积极数据。

套细胞淋巴瘤（MCL）是一种罕见侵袭性B细胞淋巴瘤，该病难以治疗且预后很差。慢性淋巴细胞白血病（CLL）是一种源于骨髓白血细胞（淋巴细胞）的血癌。染色体异常删除突变del 17p和TP53突变与癌症的恶化和耐药性相关，del 17p删除突变是指17号染色体部分片段丢失，携带该突变的CLL患者被认为预后最差。

Imbruvica（ibrutinib）是一种首创的口服布鲁顿酪氨酸激酶（BTK）抑制剂，通过抑制肿瘤细胞复制和转移需要的布鲁顿酪氨酸激酶（BTK）而起到抗癌的作用。BTK是B细胞受体信号复合体中的一种关键信号分子，在恶性B细胞的生存及扩散中起着重要作用。Imbruvica能够阻断介导恶性B细胞不可控地增殖和扩散的信号通路。

FDA分别于2013年12月、2014年2月和2014年7月批准Imbruvica用于经治套细胞淋巴瘤（MCL）、经治慢性淋巴细胞白血病（CLL）、携带del 17p删除突变的CLL的治疗。强生旗下杨森生物科技与Pharmacyclics于2011年12月签署授权协议，联合开发Imbruvica以及该药在美国的商业化，强生拥有Imbruvica在整个EMEA(欧洲、中东和非洲)以及美国以外世界其他地区的商业化权利。

英文原文：Pharmacyclics' (PCYC) IMBRUVICA Approved in Europe for Treatment of Two Blood Cancers

Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that the European Commission (EC) has granted marketing approval for IMBRUVICA® (ibrutinib) throughout the 28 member states of the European unio (EU). IMBRUVICA, a first-in-class, oral, once-daily, non-chemotherapy treatment, now is approved to be marketed in Europe for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, or in first line CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemotherapy.

IMBRUVICA is being jointly developed and commercialized in the U.S. by Pharmacyclics and Janssen Biotech, Inc. (Janssen). Janssen affiliates will hold the marketing authorization and will market IMBRUVICA in EMEA (Europe, Middle East, Africa), as well as the rest of the world, outside the U.S.

The EC approval was based on data from the Phase II study (PCYC-1104) in MCL, the Phase III RESONATE™ study (PCYC-1112-CA) in CLL and small lymphocytic lymphoma (SLL) and the Phase Ib/II study (PCYC-1102) in CLL/SLL. This approval is based on the IMBRUVICA Marketing Authorization Application (MAA) submitted to the European Medicines Agency (EMA) last year. The EMA is an agency of the EU that administers a centralized procedure for the scientific evaluation of medicines developed by pharmaceutical companies for use in the 28 countries of the EU. In addition to EU markets, a worldwide regulatory filing program for ibrutinib currently is underway.

"We are very pleased that patients with CLL and relapsed or refractory MCL in the European unio will have a first-in-class, oral, single-agent, non-chemotherapy treatment option in IMBRUVICA," said Bob Duggan, Chairman & CEO of Pharmacyclics. "This approval underscores the compelling safety and efficacy benefits of IMBRUVICA, including statistically significant improvement in overall survival and progression-free survival in CLL and the overall robustness of the data in MCL."

IMBRUVICA is approved in the U.S. for three indications: for the treatment of patients with MCL and CLL who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p), including treatment-naive and previously treated del 17p CLL patients. Accelerated approval was granted for the MCL indication based on overall response rate (ORR). Improvements in survival or disease-related symptoms have not been established in MCL. Continued approval for the MCL indication may be contingent upon verification of clinical benefit in confirmatory trials.

The following results are included in the IMBRUVICA Summary of Product Characteristics (SmPC) from EU commission review.

MCL Study Efficacy ResultsIn a multi-center, single-arm, open-label Phase II study (PCYC 1104), the efficacy of ibrutinib in 111 patients with relapsed or refractory MCL were evaluated. An ORR of 68% was observed, with a complete response rate of 21% and a partial response rate of 47%. With an estimated median follow up of 15.3 months, the estimated median response duration was 17.5 months, and the estimated median progression-free survival (PFS) was 13.9 months.1

CLL Study Efficacy ResultsRESONATE™ (PCYC-1112) is a Phase III, randomized, multi-center, open-label, international, head-to-head study of single-agent, orally-administered ibrutinib versus the intravenously administered monoclonal antibody ofatumumab, targeting the CD-20 antigen. The study enrolled 391 previously treated patients with CLL/SLL.2

At a median follow-up of 9.4 months, single-agent ibrutinib demonstrated a statistically significant improvement in PFS, overall survival (OS), and ORR, regardless of baseline characteristics, as compared with patients treated with ofatumumab.

The PFS results represent a 78% reduction in the risk of progression or death in patients treated with ibrutinib compared to ofatumumab. The OS results represent a 57% reduction in the risk of death in patients receiving ibrutinib versus those in the ofatumumab arm. The efficacy was similar across all of the subgroups examined, including in patients with and without del 17p, a pre-specified stratification factor.

As noted in the market application and reported in The New England Journal of Medicine publication, the RESonATE results were observed despite a total of 57 patients who were initially randomized to ofatumumab crossing over to receive IMBRUVICA prior to the analysis.

MCL and CLL Study Safety ResultsThe most commonly occurring adverse reactions (>20%) were diarrhea, musculoskeletal pain, upper respiratory tract infection, bruising, rash, nausea, pyrexia, neutropenia, and constipation. The most common grade 3/4 reactions (>5%) were anemia, neutropenia, pneumonia, and thrombocytopenia.

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赛诺菲/再生元启动单抗dupilumab特应性皮炎III期临床项目

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发布日期：2014-10-21  来源：生物谷

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业界认为，用于哮喘治疗时，单抗dupilumab将成为改变游戏规则的新药。dupilumab对多种炎症性疾病均具有治疗潜力。目前，赛诺菲正调查dupilumab用于哮喘、特应性皮炎（AD）、慢性鼻窦炎的治疗。

赛诺菲（Sanofi）和合作伙伴Regeneron近日宣布，启动单抗药物dupilumab III期临床项目LIBERTY AD，将调查dupilumab治疗特应性皮炎（atopic dermatitis，AD）的疗效和安全性。该项目将由至少5个III期临床试验组成，首个III期研究（LIBERTY AD CHRONOS）将招募700例中度至重度特应性皮炎（AD）成人患者，主要终点是调查dupilumab结合外用皮质类固醇治疗中度至重度特应性皮炎（AD）的疗效（16周），次要终点是评估dupilumab的长期安全性及有效性（52周）。

此前，在4项II期临床试验中，dupilumab快速且显著减少了特应性皮炎（AD）成人患者的皮肤损伤和瘙痒，目前，该病现有的治疗选择疗效十分有限。赛诺菲最初开发dupilumab用于哮喘的治疗，而这些结果表明，dupilumab潜在获益人群将从哮喘扩大至第二种特异性疾病，并还可能使其他特异性疾病患者受益。

特应性皮炎（AD）是一种慢性、复发性炎症性皮肤病，主要表现为剧烈的瘙痒、明显的湿疹样变和皮肤干燥。特应性皮炎（AD）常常自婴幼儿发病，部分患者延续终生，可因慢性复发性湿疹样皮疹、严重瘙痒、睡眠缺失、饮食限制以及心理社会影响而严重影响患者的生活质量。

目前，赛诺菲和Regeneron也正在调查dupilumab对哮喘和慢性鼻窦炎的治疗。在一项IIa期临床试验中，dupilumab消减了87%的哮喘发作，该数据是近20年中在哮喘临床试验中所取得的最激动人心的数据。对于中度至重度过敏性哮喘群体而言，dupilumab有望成为一个改变游戏规则的药物。目前哮喘的治疗一直是类似于创可贴疗法，这些疗法没有攻击到疾病的根本原因，而dupilumab可能能够解决疾病根源问题。

Dupilumab是一种全人源化单克隆抗体，靶向白介素4受体(IL-4R)的α亚基，由Regeneron公司利用其开创性的Veloclmmune技术开发，目前该公司正与赛诺菲合作开发dupilumab。

通过阻断IL-4Rα亚基，dupilumab能够调节II型辅助T细胞（Th2）免疫应答中2种驱动因子——白介素-13(IL-13)和白介素-4（IL-4）的信号通路，这2种细胞炎性因子是参与炎症反应的关键蛋白。

英文原文：Sanofi, Regeneron start Phase 3 trial of dupilumab in eczema

Sanofi and Regeneron Announce Start of Phase 3 Study of Dupilumab in Patients with Atopic Dermatitis

TARRYTOWN, N.Y. and PARIS, October 20, 2014 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD) that is not adequately controlled with topical AD medications.

LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks. Secondary objectives of the study will evaluate the long-term safety and efficacy of dupilumab up to 52 weeks. The trial will enroll approximately 700 adult patients.

"Moderate-to-severe atopic dermatitis is a serious disease characterized by severe itching, sleep disturbances and widespread rash, and existing treatment options have limited efficacy," said Donald Y. M. Leung, MD, PhD, a member of the LIBERTY AD Clinical Trials Steering Committee and Head of the Division of Pediatric Allergy and Immunology at National Jewish Health in Denver, CO. "This Phase 3 program will evaluate if blocking IL-4 and IL-13, two key cytokines in the Th2 inflammatory pathway, may provide a potential new approach for this chronic, difficult-to-manage disease."

The LIBERTY AD Phase 3 clinical program will consist of at least five trials of patients with moderate-to-severe AD at sites worldwide. For more information on the LIBERTY AD CHRonOS study, please visit: http://clinicaltrials.gov/ct2/show/NCT02260986?term=dupilumab&phase=2&rank=2.

about the IL-4/IL-13 Pathway and Atopic Dermatitis
! W  g2 y$ C! I- `Moderate-to-severe atopic dermatitis, a serious, chronic form of eczema, is a systemic inflammatory disease characterized by an allergic response driven by a subset of immune cells called Type 2 helper T cells, or Th2 cells. IL-4 and IL-13 are key cytokines that are required for the initiation and maintenance of this Th2 immune response.

Moderate-to-severe forms of atopic dermatitis can be characterized by pronounced pruritus (itch), cutaneous dryness, and skin lesions marked by redness, infiltration/papulation, crusting/oozing, and lichenification (skin thickening), with periods of lesion exacerbation. Intense itching, scratching, and skin damage can lead to secondary infections. Atopic dermatitis is often associated with other inflammatory disorders such as asthma.[1] Moderate-to-severe atopic dermatitis can negatively impact patients' lives and is associated with a high burden to society in terms of direct costs of medical care and prescription drugs and loss of productivity. [2],[3],[4],[5]

about Dupilumab
. x; Z9 f& ^+ T% I$ ]Dupilumab, a fully-human monoclonal antibody, is directed against the IL-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-13. Dupilumab was created using Regeneron's pioneering VelocImmune® technology and is being co- developed with Sanofi in atopic dermatitis, asthma and chronic sinusitis with nasal polyposis. Dupilumab is an investigational agent under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

美研究所发现枸橼酸氯米芬对抗埃博拉病毒有效

                               
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发布日期：2014-10-21  来源：大智慧阿思达克通讯社  

( O4 E0 Q1 K5 W  O9 h$ b2 S美国陆军感染病医学研究所通过基于eGFP-EBOV的高通量筛选方法发现，枸橼酸氯米芬具有抗埃博拉病毒的活性。
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　　早在去年6月，美国国家卫生研究院的国家医学图书馆旗下刊物已有文献记载，研究人员发现雌激素受体调节剂（SERM）， 包括克罗米酚（clomiphene）以及托瑞米芬（toremifene）能起到抑制埃博拉病毒的作用，效果在两个活体小鼠体内得到确认。

　　国家食药监总局（CFDA）网站信息显示，克罗米酚即枸橼酸氯米芬在国内的生产企业包括太极集团子公司--西南药业、华润双鹤；枸橼酸托瑞米芬在国内生产企业仅宁波天衡药业股份有限公司。
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关于枸橼酸氯米芬：

药物名称： 枸橼酸氯米芬

药物别名： 枸橼酸氯底酚胺、克罗米酚、氯米芬

英文名称： Clomifene Citrate

枸橼酸氯米芬是抗性激素药。本品刺激排卵的机制尚不完全明了。由于本品对雌激素有弱的激动与强的拮抗双重作用，刺激排卵可能是在下丘脑部位，首先拮抗占优势，通过竞争性占据下丘脑雌激素受体，干扰着内源性雌激素的负反馈，促使黄体生成激素与促卵泡生成激素的分泌增加，继之刺激卵泡生长，卵泡成熟后，雌激素的释放量增加，通过正反馈激发排卵前促性腺激素的释放达峰值，于是排卵。

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临床方面自己好好学习下