{"id":876,"date":"2021-09-27T11:20:00","date_gmt":"2021-09-27T11:20:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3519499_HK19499_0"},"modified":"2021-09-27T11:20:00","modified_gmt":"2021-09-27T11:20:00","slug":"senhwa-announces-acceptance-of-early-positive-covid-19-phase-ii-study-abstract-for-presentation-at-the-isirv-who-conference","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=876","title":{"rendered":"Senhwa Announces Acceptance of Early Positive COVID-19 Phase II Study Abstract for Presentation at the ISIRV-WHO Conference"},"content":{"rendered":"<div id=\"dvContent\" readability=\"109.13096535193\">\n<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1612512\/Senhwa_Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li><b><i>Early Positive Phase 2 efficacy and safety data are both statistically significant and clinically meaningful.<\/i><\/b> <\/li>\n<li><b><i>No SAE related to Silmitasertib was reported. <\/i><\/b><\/li>\n<li><b><i>Silmitasertib is a host-directed antiviral and an anti-inflammatory investigational therapy expected to be effective against emerging <span id=\"spanHghltfbc4\">SARS-CoV-2<\/span> variants.<\/i><\/b> <\/li>\n<li><b><i>Silmitasertib is the first <span class=\"xn-location\">Taiwan<\/span> biotech company&#8217;s innovative drug to demonstrate efficacy in COVID-19 patients.<\/i><\/b><\/li>\n<\/ul>\n<p><span class=\"xn-location\">TAIPEI<\/span> and <span class=\"xn-location\">SAN DIEGO<\/span>, <span class=\"xn-chron\">Sept. 27, 2021<\/span> \/PRNewswire\/ &#8212; Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced the acceptance of early positive Phase 2 efficacy and safety data abstract for Silmitasertib in moderate <span id=\"spanHghlt81ed\">COVID-19<\/span> patients at the<i><u> ISIRV-WHO Virtual Conference-COVID-19, Influenza and RSV: Surveillance-informed prevention and treatment<\/u><\/i> being held on 19-<span id=\"spanHghlt1123\">21<\/span> October, 2021. The ongoing Phase 2 trial data will be presented at the conference.<\/p>\n<p>The conference will address the evolution, epidemiology and impact of SARS-CoV-2, influenza, RSV and other respiratory viruses, implications for surveillance strategies and progress on vaccines, antivirals, immunomodulators and other countermeasures.<\/p>\n<p>&#8220;We are very pleased with the early efficacy and safety results of this Phase 2 study, which demonstrated statistically significant and clinical meaningful reduction in relevant endpoints, including time to recovery and normalization of clinical signs. We believe Silmitasertib in its significant potential in treating COVID-19, both as antiviral and anti-inflammatory agent, helping to prevent effects that lead to severity or death,&#8221; said <span class=\"xn-person\">Tai-Sen Soong<\/span>, Chief Executive Officer of Senhwa Biosciences.<\/p>\n<p>The efficacy and safety of Silmitasertib was evaluated in a randomized, open-label, 2 arm parallel-group controlled interventional prospective phase 2 study conducted in two sites in the US. Participants were randomized if they had signs or symptoms of moderate COVID-19 and a positive SARS-CoV-2 RT-PCR or equivalent testing. 20 participants were randomized in a 1:1 ratio to receive 1,000 mg BID oral dose Silmitasertib in addition to SOC\/best supportive care or SOC\/best supportive care alone for 14 days. During the study, no patients on the Silmitasertib arm received concomitant COVID-19 therapies.<\/p>\n<p>Senhwa Biosciences is the first and only <span class=\"xn-location\">Taiwan<\/span> based company to demonstrate human efficacy against SARS-CoV-2 with its investigational anti-COVID19 therapy. Silmitasertib targets host cell protein, Casein Kinase 2, and this unique and strategic clinical approach is expected to be effective against the emerging <span id=\"spanHghltd644\">SARS-CoV-2<\/span> variants.<\/p>\n<p><b><i>About Silmitasertib<\/i><\/b><\/p>\n<p>Silmitasertib is a first-in-class small molecule drug that targets the CK2 pathway and acts as a CK2-inhibitor. It is safe and well-tolerated in humans. In addition to COVID-19, Silmitasertib is currently under development in several oncology programs in adults and children with recurrent\/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently, there are two ongoing Phase II studies of Silmitasertib. US FDA granted Silmitasertib key drug designations, an Orphan Drug Designation for the treatment of Cholangiocarcinoma in <span class=\"xn-chron\">December 2016<\/span>, a Rare Pediatric Disease Drug Designation and a Fast Track Designation for the treatment of Medulloblastoma in <span class=\"xn-chron\">July 2020<\/span> and <span class=\"xn-chron\">August 2021<\/span> respectively and an eIND for the treatment of a patient with severe COVID-19 in <span class=\"xn-chron\">August 2020<\/span>. All clinical trial data and rights of Silmitasertib belong to Senhwa Biosciences.<\/p>\n<p><b><i>About Senhwa Bioscience<\/i><\/b><\/p>\n<p>Senhwa Biosciences, Inc. is a leading clinical-stage biotechnology company focusing on developing first-in-class, next-generation DNA Damage Response therapeutics for patients with unmet medical needs in oncology. Headquartered in <span class=\"xn-location\">Taiwan<\/span>, with an operational base in <span class=\"xn-location\">San Diego, California<\/span>, Senhwa is well-positioned to oversee the development of its compounds.<\/p>\n<p>Development is currently focused on two lead products Silmitasertib (CX-4945) and Pidnarulex (CX-5461) with novel mechanisms of action and for multiple indications. Clinical trials are currently ongoing in <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">Canada<\/span>, <span class=\"xn-location\">United States<\/span>, Korea and <span class=\"xn-location\">Taiwan<\/span>.<\/p>\n<p>Visit Senhwa Biosciences website for more details: <a target=\"_blank\" href=\"http:\/\/www.senhwabio.com\/\" rel=\"nofollow noopener\">www.senhwabio.com<\/a><\/p>\n<p id=\"PURL\"><img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=HK19499&amp;sd=2021-09-27\"> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow noopener\" href=\"https:\/\/www.prnewswire.com\/news-releases\/senhwa-announces-acceptance-of-early-positive-covid-19-phase-ii-study-abstract-for-presentation-at-the-isirv-who-conference-301385476.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/senhwa-announces-acceptance-of-early-positive-covid-19-phase-ii-study-abstract-for-presentation-at-the-isirv-who-conference-301385476.html<\/a><\/p>\n<\/p><\/div>\n<p>Source: Senhwa Biosciences, Inc.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Early Positive Phase 2 efficacy and safety data are both statistically significant and clinically meaningful. No SAE related to Silmitasertib was reported. Silmitasertib is a host-directed antiviral and an anti-inflammatory investigational therapy expected to be effective against emerging SARS-CoV-2 variants. Silmitasertib is the first Taiwan biotech company&#8217;s innovative drug to demonstrate efficacy in COVID-19 patients. [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":877,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-876","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Senhwa Announces Acceptance of Early Positive COVID-19 Phase II Study Abstract for Presentation at the ISIRV-WHO Conference - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=876\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Senhwa Announces Acceptance of Early Positive COVID-19 Phase II Study Abstract for Presentation at the ISIRV-WHO Conference - My Blog\" \/>\n<meta property=\"og:description\" content=\"Early Positive Phase 2 efficacy and safety data are both statistically significant and clinically meaningful. No SAE related to Silmitasertib was reported. Silmitasertib is a host-directed antiviral and an anti-inflammatory investigational therapy expected to be effective against emerging SARS-CoV-2 variants. Silmitasertib is the first Taiwan biotech company&#8217;s innovative drug to demonstrate efficacy in COVID-19 patients. 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