RedHill Biopharma启动针对新冠肺炎的全球范围2/3期新药研究

Written by Customer Service on August 2, 2020. Posted in Public Companies.

全球2/3期研究将通过40个临床地点共招募270名新冠肺炎患者；这项研究已在英国和俄罗斯获得批准，目前正在意大利、巴西和墨西哥进行审核—一项在美国进行的新冠肺炎重症患者平行2期研究将于2020年8月完成，以色列特拉维夫和北卡罗来纳州罗利, Aug. 03, 2020 (GLOBE NEWSWIRE) — 特种生物制药企业RedHill Biopharma Ltd.（纳斯达克：RDHL）（以下称“RedHill”或该“公司”）今天宣布，该公司启动了一项全球2/3期临床研究，以评估在因重度SARS-CoV-2（新型冠状病毒，新冠肺炎的致病原因）感染和肺炎住院并需要补充供氧治疗的患者中使用opaganib（Yeliva®，ABC294640）1的疗效。“继接受同情用药的患者取得令人振奋的效果后，我们将继续快速推进计划的进展，以评估opaganib对重症新冠肺炎患者的疗效和安全性，”RedHill医疗总监Mark L. Levitt医学博士表示。“我们迅速在美国启动了2期研究，目前正通过2/3期研究在全球扩展该计划，以使我们能够在短时间内收集到广泛而严密的数据集。opaganib有可能通过其抗炎和抗病毒活动的双重机制，以独特方式治疗新冠肺炎。我们对该计划的前景感到振奋，这项计划的目标是在获得成功后支持全球紧急应用。”这是一项多中心、随机、双盲、平行分组、安慰剂对照的2/3期研究（NCT04467840），计划在欧洲、拉丁美洲和其他国家多达40个临床地点招募270名患者。目前已制定计划将这项研究进一步扩展到更多国家。本次研究的受试者将以1:1的比例随机分组，接受opaganib或安慰剂用药，并按医护标准接受治疗。该研究的主要终点是评估在第14天时需要插管和呼吸机的患者比例。在大约100名受试者接受主要终点评估之后，一家独立数据安全监测委员会（DSMB）将进行解盲无效中期分析。此外，在美国的一项使用opaganib进行随机、双盲、安慰剂对照2期临床研究（NCT04414618）的受试者招募也正在进行中。这项研究旨在招募40名需要住院治疗和辅助吸氧的新冠肺炎重症患者参与试验，招募预计于八月完成。这次临床试验并非以统计意义为目的。关于opaganib（ABC294640，Yeliva®）opaganib是一种新的化学体，一种专有的首创性口服鞘氨醇激酶-2（SK2）选择性抑制剂，具有抗肿瘤、抗炎和抗病毒活性，针对多种肿瘤、病毒、炎症和肠道适应症。通过抑制SK2，opaganib可影响与癌细胞生长、病毒复制和病理炎症相关的多种蜂窝路径。opaganib最初由美国Apogee...

RedHill Biopharma 在全球開展第 2/3 期 COVID-19 研究

Written by Customer Service on August 2, 2020. Posted in Public Companies.

全球第 2/3 期研究將在 40 個臨床中心納入多達 270 名嚴重 COVID-19 患者；該研究已獲得英國和俄羅斯批准，而意大利、巴西和墨西哥正在審核中—預計將於 2020 年 8 月完成美國嚴重 COVID-19 患者的第 2 期平行研究納入工作—緊急使用申請計劃最早於 2020 年第四季提交以色列特拉維夫和北卡羅萊納州拉里格, Aug. 03, 2020 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (Nasdaq: RDHL)（簡稱 RedHill 或「該公司」），是一家專門生物製藥公司，今天宣佈已啟動全球第 2/3 期臨床研究，以評估 opaganib (Yeliva®, ABC294640)1 用於嚴重 SARS-CoV-2 感染（COVID-19 病因）及需要補充氧氣治療的肺炎住院患者。RedHill 醫療總監 Mark L. Levitt 博士醫生表示：「在同情使用治療的患者獲得令人鼓舞的結果後，我們將繼續快速展開研發計劃，以評估 opaganib 對嚴重 COVID-19 患者的療效和安全性。我們已迅速在美國啟動了第 2 期研究，現正以第 2/3 期研究在全球擴展研究計劃，讓我們能在短時間內收集廣泛而嚴格的數據集。Opaganib 備有抗炎和抗病毒活性的雙重機制，獨具抵抗 COVID-19 的潛力。我們對計劃的前景感到興奮，若取得成功，計劃旨在支援全球緊急應用。」這項多中心、隨機、雙盲、平行組、安慰劑對照的第 2/3 期研究 (NCT04467840) 旨在於歐洲、拉丁美洲和其他國家/地區多達 40 個臨床中心納入 270 名患者。計劃將研究進一步擴展至其他國家/地區。在研究納入的受試者將以 1:1 的比例隨機分配接受 opaganib 或安慰劑，加上標準護理。研究的主要終點是在第 14 天之前評估需要插喉和機械呼吸的患者比例。在評估大約 100 名受試者的主要終點時，獨立的數據安全監控委員會...

Vanstar Announces CEO’s Retirement

Written by Customer Service on August 2, 2020. Posted in Public Companies.

THIS RELEASE MAY NOT BE DISTRIBUTED TO US WIRE SERVICES FOR UNITED STATES DISTRIBUTIONMONTREAL, Aug. 02, 2020 (GLOBE NEWSWIRE) — The management of Vanstar Mining Resources announces the retirement of director and Vanstar’s CEO, Mr. Guy Morissette. The withdrawal of Mr. Morissette is effective immediately.Mr. Jonathan Hamel, director of the company will act as interim CEO, until a new CEO is appointed as soon as possible by a committee formed by the board of directors.We thank Mr. Morissette for his 12 years at the helm of the company as well as for his direct participation in the discovery of one of the most important gold projects in Quebec, the Nelligan deposit. Mr. Morissette leaves the company in very good financial health with very good gold projects and a low dilution of its capital structure.“I am very happy to have directly...

Investam-HK: Major Stocks closed market higher as Coronavirus fear vs dies down

Written by Customer Service on August 2, 2020. Posted in Public Companies.

Stocks quite bounce back a few points from what they have loss the other day after investors got optimistic on the upcoming stimulus package from the Federal Reserve of the US government, aside from it Fed’s kept interest rates as is. Tech giants made an impact just before the market close this Wednesday. Facebook just closed its trading price 1.38% higher while Amazon ended the session up by 1.11%. Alphabet advanced a bit with 1.32% while Apple increased 1.92%. Here are the main movements in the Global Market; Stocks – The S&P 500 have gained good points with 1.24% to 3,258.44.– The Dow Jones Industrial Average increased about 160.29 points or .69% to 26,539.57.– Nasdaq Composite rose a few percentage at 1.35% to 10,542.94 getting a few points of what they have loss the other day.– The MSCI Asia Pacific Index...

Reliance Trading Co. Limited: Stock Market fell together with Oil prices and Treasuries, Gold is up

Written by Customer Service on August 2, 2020. Posted in Public Companies.

Major stocks have lost its pace on Tuesday market closing all prices lower from yesterday’s session. Shares from tech giants dropped as traders are getting ready for the next coronavirus stimulus package. Facebook fell 1.45%. Amazon, Netflix and Apple all dropped at least 1.40%, which contributed on Nasdaq and the Dow’s performance today. Treasuries are also down after Federal Reserve of the U.S. government began its two-day policy meeting. Here are the main movements on the stock market; Stocks – The S&P 500 loss a few points by 0.65% to 3,218.44.– The Dow Jones Industrial Average is down 205.49 points lower or 0.77%, to 26,379.28, erasing some of its gain yesterday.– The Nasdaq Composite dipped few points with -1.27% to 10,402.09.– The MSCI Asia Pacific Index advanced 0.4%.– The Stoxx Europe 600 Index...

Elite Capital International: Global Market ended up higher lead by Gold hitting new record high

Written by Customer Service on August 2, 2020. Posted in Public Companies.

Gold prices has set new record high pushing the precious metal’s stock to climbed up big time, setting it as its biggest gain in one year since 2010. Amazon (Nasdaq Composite) and Apple (Dow) have led Technology sector on this week’s opening rally, with 1.54% and 2.37% gained respectively. Other tech giants like Facebook, Netflix, Alphabet and Microsoft have ended the day higher as well. Here are the main movements on the stock market this Monday; Stocks – The Dow Jones Industrial Average climbed up with 114.88 points or 0.43% to 26,584.77 as market closed this Monday.– The S&P 500 rose quite impressively with 0.74% to 3,239.41.– Nasdaq Composite erased some of its loss from last week after most investors profit take, gaining at least 1.67% to 10,536.27.– The MSCI Asia Pacific Index increased 0.8%.– The...

Day: August 2, 2020