{"id":2302,"date":"2017-09-12T18:18:58","date_gmt":"2017-09-12T12:48:58","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2302"},"modified":"2021-07-24T12:56:50","modified_gmt":"2021-07-24T07:26:50","slug":"notizia-50","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-50","title":{"rendered":"Idera\u2019s Phase I Data; DelMar Initiates Trial; Novartis\u2019 study; Humira gets EC approval"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a038eeb4a56e\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a038eeb4a56e\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-50\/#Idera_Pharmaceuticals_Present_Positive_Phase_I_Data_for_their_Drug_candidate_IMO-2125\" >Idera Pharmaceuticals Present Positive Phase I Data for their Drug candidate IMO-2125<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-50\/#DelMar_Pharmaceuticals_Initiates_Phase_2_Trial_for_VAL-083_in_GlioblastomaMultiforme\" >DelMar Pharmaceuticals Initiates Phase 2 Trial for VAL-083 in GlioblastomaMultiforme<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-50\/#Novartis_Phase_III_study_demonstrates_reduced_risk_of_disease_recurrence_by_53\" >Novartis Phase III study demonstrates reduced risk of disease recurrence by 53%<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-50\/#Humira_gets_EC_approval_for_anterior_uveitis\" >Humira gets EC approval for anterior uveitis<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Idera_Pharmaceuticals_Present_Positive_Phase_I_Data_for_their_Drug_candidate_IMO-2125\"><\/span><strong>Idera Pharmaceuticals Present Positive Phase I Data for their Drug candidate IMO-2125<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Idera Pharmaceuticals announced final results from the dose-selection phase of an ongoing Phase 1\/2 trial investigating IMO-2125 in combination with ipilimumab (Yervoy). The combination dose-selection phase included 18 patients, all but one of whom had progressed on nivolumab or pembrolizumab.\u00a0 Patients were treated with up to 6 doses of intratumoral IMO-2125 at doses ranging from 4 to 32 mg, along with standard dosing of ipilimumab.\u00a0 No dose-limiting toxicities were seen and the maximum tolerated dose (MTD) was not reached.\u00a0 No previously unreported immune-related toxicities were observed.\u00a0 The 8 mg IMO-2125 dose was selected for further development in combination with ipilimumab based upon acceptable safety, clinical activity, and evidence of target engagement on serial biopsies of the injected tumor and a distant (non-injected) metastasis.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"DelMar_Pharmaceuticals_Initiates_Phase_2_Trial_for_VAL-083_in_GlioblastomaMultiforme\"><\/span><strong>DelMar Pharmaceuticals Initiates Phase 2 Trial for VAL-083 in GlioblastomaMultiforme<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">DelMar Pharmaceuticals announced the initiation of Phase 2 clinical trial for its lead agent VAL-083 in newly diagnosed MGMT-unmethylatedglioblastomamultiforme (GBM). The biomarker-driven clinical trial will explore safety and efficacy of chemoradiation with VAL-083 as an alternative to standard-of-care temozolomide in patients with MGMT-unmethylated GBM. The trial, which is being funded under the terms of DelMar&#8217;s collaboration with Guangxi Wuzhou Pharmaceutical Group Co. Ltd. (Guangxi Wuzhou Pharma), is being conducted at Sun Yat-sen University Cancer Center (SYUCC) in Guangzhou, China. The study will enroll 20-30 newly diagnosed GBM patients whose tumors exhibit high-expression of the DNA-repair enzyme O6-methylguanine methyltransferase (MGMT) and will be treated with VAL-083 in combination with radiotherapy to examine the safety and efficacy of VAL-083 in this population.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Novartis_Phase_III_study_demonstrates_reduced_risk_of_disease_recurrence_by_53\"><\/span><strong>Novartis Phase III study demonstrates reduced risk of disease recurrence by 53%<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Novartis has published positive Phase III results of an 870 patient study with stage III BRAF V600E\/K mutation-positive melanoma. The trial saw reduced recurrence rate of 53% after treatment with the combination of Tafinlar(dabrafenib) + Mekinist (trametinib). The trial met its primary endpoint by observing a reduction in the risk of death or recurrence in patients treated with the BRAF and MEK inhibitor combination therapy versus placebo. Adverse events (AEs) were consistent with other Tafinlar + Mekinist studies, and no new safety signals were reported.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Humira_gets_EC_approval_for_anterior_uveitis\"><\/span><strong>Humira gets EC approval for anterior uveitis<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The European Commission has approved AbbVie&#8217;s Humira for the treatment of chronic non-infectious anterior uveitis in children aged two years or older who have had an inadequate response to or are intolerant to conventional therapy. Humira is now the only approved biologic treatment option for chronic non-infectious anterior uveitis in children aged two years and older in the European Union. Uveitis is an inflammation of the iris, choroid and the ciliary body in the eye. If left untreated, the disease can cause severe vision loss.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Idera Pharmaceuticals Present Positive Phase I Data for their Drug candidate IMO-2125 Idera Pharmaceuticals announced final results from the dose-selection phase of an ongoing Phase 1\/2 trial investigating IMO-2125 in combination with ipilimumab (Yervoy). The combination dose-selection phase included 18 patients, all but one of whom had progressed on nivolumab or pembrolizumab.\u00a0 Patients were treated [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2303,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[17568,16690,17569,900,1210,423,502],"industry":[17225],"therapeutic_areas":[17227,17228],"class_list":["post-2302","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-delmar-pharmaceuticals","tag-glioblastoma-multiforme","tag-glioma","tag-humira","tag-idera-pharmaceuticals","tag-novartis","tag-rare-disease","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the 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href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">DelMar Pharmaceuticals<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Glioblastoma multiforme<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Glioma<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Humira<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Idera Pharmaceuticals<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Novartis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Rare Disease<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">DelMar Pharmaceuticals<\/span>","<span class=\"advgb-post-tax-term\">Glioblastoma multiforme<\/span>","<span class=\"advgb-post-tax-term\">Glioma<\/span>","<span class=\"advgb-post-tax-term\">Humira<\/span>","<span class=\"advgb-post-tax-term\">Idera Pharmaceuticals<\/span>","<span class=\"advgb-post-tax-term\">Novartis<\/span>","<span class=\"advgb-post-tax-term\">Rare Disease<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Sep 12, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Sep 12, 2017 6:18 pm","modified":"Updated on Jul 24, 2021 12:56 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