{"id":143802,"date":"2020-05-04T06:40:14","date_gmt":"2020-05-04T06:40:14","guid":{"rendered":"https:\/\/www.bnreport.com\/imugene-receives-independent-confirmation-of-her-vaxx-safety\/"},"modified":"2020-05-04T06:40:14","modified_gmt":"2020-05-04T06:40:14","slug":"imugene-receives-independent-confirmation-of-her-vaxx-safety","status":"publish","type":"post","link":"https:\/\/www.bnreport.com\/en\/imugene-receives-independent-confirmation-of-her-vaxx-safety\/","title":{"rendered":"Imugene receives independent confirmation of HER-Vaxx safety"},"content":{"rendered":"<p>Imugene Limited (<a href=\"https:\/\/www.proactiveinvestors.co.uk\/ASX:IMU\/Imugene-Ltd\/\" rel=\"noreferrer noopener\" target=\"_blank\">ASX:IMU<\/a>) (OTCMKTS:IUGNF) has received confirmation from the Independent Data Monitoring Committee (IDMC) of the safety and importance of the HER-Vaxx cancer immunotherapy.<\/p>\n<p>The IDMCs role is to review study data and conduct a formal independent review of key data such as deaths, adverse reactions and laboratory results, enabling the IDMC to clearly weigh the benefits and risks of continued study participation.<\/p>\n<p>As a result of the review, the IDMC chair confirmed the IDMC members had no safety concerns and that the study should continue without modification.<\/p>\n<p>The IDMC has encouraged Imugene to push ahead with this important study.<\/p>\n<h4>\u201cSignificant milestone\u201d[hhmc]<br \/>\n<\/h4>\n<p>Imugene managing director and CEO Leslie Chong said: \u201cI am happy to report that we have achieved this significant milestone and Im highly encouraged by the positive outcome of this first IDMC meeting.<\/p>\n<p>\u201cI am truly pleased with the study progress to date.\u201d<\/p>\n<p>Imugenes HER-Vaxx is a B-cell peptide cancer immunotherapy designed to treat tumours that over-express the HER-2\/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.<\/p>\n<p>The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2\/neu.<\/p>\n<p>It has been shown in pre-clinical studies and in Phase I studies to stimulate a potent polyclonal antibody response to HER-2\/neu, a well-known and validated cancer target.<\/p>\n<h4>Benefit of IDMC review[hhmc]<br \/>\n<\/h4>\n<p>The IDMC ensures the interests of patients entered on the trial are being well-served (ie, that the risk-benefit ratio is appropriate) and that the scientific integrity of the trial is maintained between trial initiation and completion.<\/p>\n<p>A key benefit of IDMC review of trial data is an independent assessment to assure that study participants are not exposed to unnecessary or unreasonable risks because of their trial participation.<\/p>\n<p>The IDMC is a key process by which the highest scientific and ethical standards are maintained in a clinical trial.<\/p>\n<p>It conducts business in \u201cclosed sessions\u201d with meetings attended only by members of the IDMC, thereby maintaining independence from the sponsor.<\/p>\n<p>IDMCs analyse ongoing data for randomised studies, including those that involve multiple sites and when statistically required per protocol, analyse important clinical endpoints such as survival or disea<a href=\"https:\/\/www.proactiveinvestors.co.uk\/companies\/news\/918685\/imugene-receives-independent-confirmation-of-her-vaxx-safety-918685.html\" rel=\"noreferrer noopener\" target=\"_blank\">Read More \u2013 Source<\/a><br \/>\n[contf]<br \/>\n[contfnew]<br \/>\n        <img decoding=\"async\" src=\"https:\/\/webfiles.thecse.com\/PRO_LOGO_P_COLOUR.png?sYToe11NLbcXiyGkVa5syF9WB04cy98G\"\/><\/p>\n<h5><a href=\"https:\/\/www.proactiveinvestors.co.uk\/\" rel=\"noreferrer noopener\" target=\"_blank\">Proactiveinvestors<\/a><\/h5>\n<p>[contfnewc]<br \/>\n[contfnewc]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Imugene Limited (ASX:IMU) (OTCMKTS:IUGNF) has received confirmation from the Independent Data Monito..<\/p>\n","protected":false},"author":1,"featured_media":143803,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[46],"tags":[],"class_list":["post-143802","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-politics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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