{"id":14675,"date":"2011-03-12T04:33:00","date_gmt":"2011-03-12T09:33:00","guid":{"rendered":"http:\/\/asweetlife.org\/?p=14675"},"modified":"2015-12-30T03:28:01","modified_gmt":"2015-12-30T08:28:01","slug":"gsk-type-1-diabetes-drug-otelixizumab-fails-in-phase-3-study","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=14675","title":{"rendered":"GSK Type 1 Diabetes Drug, Otelixizumab, Fails in Phase 3 Study"},"content":{"rendered":"
\n
\"\"<\/a>GlaxoSmithKline and Tolerx, Inc’s Investigatinal immunotherapy,\u00a0Otelixizumab,\u00a0 for type 1 diabetes failed to meet primary end point in the Phase 3 DEFEND-1 study. Otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type 1 diabetes.<\/p>\n
\n

Following preliminary review of the data, no new or unexpected treatment-related safety concerns have emerged during the DEFEND-1 study. Study investigators and regulatory agencies have been notified of the DEFEND-1 study outcome.<\/p>\n<\/div>\n

GSK will continue to explore additional dosing regimens to inform decisions about the future clinical development program for otelixizumab. New recruitment and dosing in the DEFEND-2 study, the ongoing confirmatory Phase III study with a design similar to DEFEND-1, has been suspended pending review of the DEFEND-1 results.<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

GlaxoSmithKline and Tolerx, Inc’s Investigatinal immunotherapy, Otelixizumab, for type 1 diabetes failed to meet primary end point in the Phase 3 DEFEND-1 study. Otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide…<\/p>\n","protected":false},"author":131,"featured_media":29403,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1445],"tags":[1049],"yoast_head":"\nGSK Type 1 Diabetes Drug, Otelixizumab, Fails in Phase 3 Study<\/title>\n<meta name=\"description\" content=\"GlaxoSmithKline and Tolerx's Investigatinal immunotherapy, Otelixizumab, for type 1 diabetes failed to meet primary end point 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