{"id":395356,"date":"2020-12-08T09:02:29","date_gmt":"2020-12-08T14:02:29","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=395356"},"modified":"2020-12-08T09:02:29","modified_gmt":"2020-12-08T14:02:29","slug":"cyxone-receives-regulatory-approval-to-initiate-a-clinical-phase-2-study-with-rabeximod-in-covid-19-patients","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cyxone-receives-regulatory-approval-to-initiate-a-clinical-phase-2-study-with-rabeximod-in-covid-19-patients\/","title":{"rendered":"Cyxone receives regulatory approval to initiate a clinical Phase 2 study with Rabeximod in Covid-19 patients"},"content":{"rendered":"
\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n STOCKHOLM<\/span>, Dec. 8, 2020<\/span> \/PRNewswire\/ — Cyxone (publ.) announced today it has received approval from the regulatory authority and the ethics committee in Poland<\/span> to initiate a Phase 2 clinical trial with Rabeximod in moderate Covid-19 patients. The oral treatment is intended to prevent the progression to acute respiratory distress symptoms (ARDS) caused by virus-related overactivation of the immune system. Preliminary results are expected in the third quarter of\u00a02021.<\/b><\/p>\n

Most individuals infected with Covid-19 experience only mild symptoms. However, in some patients there is a risk that the immune system overreacts, triggering a disproportionate release of cytokines and chemokines leading to hyperinflammation and severe respiratory failure.\u00a0The urgent need for safe, effective and easily administered therapies to prevent progression from a moderate to acute disease state was recently emphasized in a JAMA (Journal of the American Medical Association) article by Dr Anthony S. Fauci<\/span> and two other representatives of the US National Institutes of Health1<\/sup>. <\/p>\n

Cyxone is contracting a number of clinical sites in Poland<\/span> and preparations are in place to expediently initiate patient inclusion. In parallel, the company has filed for regulatory approval in Slovakia<\/span>, and is preparing for submissions in additional countries. To evaluate the efficacy of the candidate drug, 300 patients suffering from moderate Covid-19, in need of oxygen treatment but not ventilator treatment, will receive one of two doses of Rabeximod or placebo in a double-blinded study. Cyxone aims to present preliminary study data in Q3 2021.<\/p>\n

Due to Cyxone’s recent funding initiatives, the ensuing study is fully financed. Given a positive study outcome, the company plans to enter into a strategic partnership with a global pharmaceutical company in order to further progress the development and commercialization of Rabeximod in Covid-19 and other virally induced respiratory diseases.<\/p>\n

“We are pleased to soon initiate our Phase 2 study in which we aim to develop an oral treatment for moderate Covid-19 patients, preventing the progression to acute symptoms avoiding the need of intensive care treatment and relieving the burden on hospitals and healthcare systems. Given a successful outcome, Rabeximod could be developed as a candidate drug not only for Covid-19, but for the treatment of other disorders of the immune system including virally induced acute respiratory disorders”, comments CEO Tara Heitner<\/span>. <\/p>\n

\n 1<\/sup>Kim PS, Read SW, Fauci AS. Therapy for Early COVID-19: A Critical Need. JAMA<\/i>. 2020;324(21):2149-2150. doi:10.1001\/jama.2020.22813. Read the article: https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2773058<\/a><\/p>\n

\n
\n Contact <\/b>
\n <\/b>\n <\/p>\n

\n Tara Heitner<\/span>, CEO
Tel: +46 70 781 88 08
Email: tara.heitner@cyxone.com<\/a>
Adelgatan 21
211 22 Malm\u00f6, Sweden<\/span><\/p>\n

\n
\n About Cyxone <\/b>
\n <\/b>\n <\/p>\n

Cyxone AB (publ) (Nasdaq First North Growth Market: CYXO) develops disease modifying therapies for diseases such as rheumatoid arthritis and multiple sclerosis as well as treatments for virally induced acute respiratory disorders. Rabeximod is a Phase 2 candidate drug\u00a0being evaluated\u00a0for the management of rheumatoid arthritis and\u00a0moderate\u00a0Covid-19 infections. T20K is a Phase 1 candidate drug for treatment of multiple sclerosis. Certified Adviser is Mangold Fondkommission AB, +46 (0)8 503 015 50,\u00a0ca@mangold.se<\/a>. For more information, please visit www.cyxone.com<\/a>.\u00a0\u00a0<\/p>\n

This information was brought to you by Cision http:\/\/news.cision.com<\/a><\/p>\n

\n https:\/\/news.cision.com\/cyxone\/r\/cyxone-receives-regulatory-approval-to-initiate-a-clinical-phase-2-study-with-rabeximod-in-covid-19-,c3251051<\/a>\n <\/p>\n

The following files are available for download:<\/p>\n

\n\n\n
\n

\n
\n https:\/\/mb.cision.com\/Main\/16882\/3251051\/1345692.pdf<\/a>
\n <\/span>\n <\/p>\n<\/td>\n

\n

\n Open Press release<\/span>\n <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n

\n \"Cision\" View original content:http:\/\/www.prnewswire.com\/news-releases\/cyxone-receives-regulatory-approval-to-initiate-a-clinical-phase-2-study-with-rabeximod-in-covid-19-patients-301188427.html<\/a><\/p>\n

SOURCE Cyxone<\/p>\n<\/p><\/div>\n

\"\"<\/p>\n","protected":false},"excerpt":{"rendered":"

PR Newswire STOCKHOLM, Dec. 8, 2020 \/PRNewswire\/ — Cyxone (publ.) announced today it has received approval from the regulatory authority and the ethics committee in Poland to initiate a Phase 2 clinical trial with Rabeximod in moderate Covid-19 patients. The oral treatment is intended to prevent the progression to acute respiratory distress symptoms (ARDS) caused by virus-related overactivation of the immune system. Preliminary results are expected in the third quarter of\u00a02021. Most individuals infected with Covid-19 experience only mild symptoms. However, in some patients there is a risk that the immune system overreacts, triggering a disproportionate release of cytokines and chemokines leading to hyperinflammation and severe respiratory failure.\u00a0The urgent need for safe, effective and easily administered therapies to prevent progression … <\/p>\n

Continue reading “Cyxone receives regulatory approval to initiate a clinical Phase 2 study with Rabeximod in Covid-19 patients”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-395356","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nCyxone receives regulatory approval to initiate a clinical Phase 2 study with Rabeximod in Covid-19 patients - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/cyxone-receives-regulatory-approval-to-initiate-a-clinical-phase-2-study-with-rabeximod-in-covid-19-patients\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cyxone receives regulatory approval to initiate a clinical Phase 2 study with Rabeximod in Covid-19 patients - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire STOCKHOLM, Dec. 8, 2020 \/PRNewswire\/ — Cyxone (publ.) announced today it has received approval from the regulatory authority and the ethics committee in Poland to initiate a Phase 2 clinical trial with Rabeximod in moderate Covid-19 patients. 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