Prokarium \u201cone of Riyadh Valley portfolio companies\u201d, a private biotechnology company developing vaccines against infectious diseases and immunotherapy for solid tumors, has received Clinical Trial Authorization (CTA) acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to run a first-in-human Phase I trial with Entervax\u2122, a bivalent vaccine against enteric fever. Prokarium anticipates dosing of the first subject to begin in the first quarter of 2020.
The trial is part of a collaboration between Prokarium and the Wellcome Trust, which invested \u00a34.6m earlier this year to fund two clinical trials with Entervax\u2122. The MHRA approved trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and immunogenicity of Entervax\u2122 in healthy volunteers.
\u201cThe Entervax\u2122 CTA is additional validation of our vaccine candidate and underlying technology. Importantly, it brings Entervax\u2122 one step closer to those who need it\u201d said Prokarium\u2019s CEO Ted Fjallman, Ph.D. The endemic population in low- and middle-income countries (LMICs) is about 5.6 billion of which 1.6 billion are at high-risk of developing a typhoid infection. This is complicated by the spread of an extensively drug resistant (XDR) strain which is creating a growing global demand for new vaccines. Entervax\u2122 has the potential to provide broader protection for these at-risk individuals in LMICs and travellers to those countries. Following this Phase I trial, Prokarium plans to run a Phase Ib age-descending, dose-escalation study in South Asia.<\/p>\n","protected":false},"excerpt":{"rendered":"
Prokarium \u201cone of Riyadh Valley portfolio companies\u201d, a private biotechnology company developing vaccines against infectious diseases and immunotherapy for solid tumors, has received Clinical Trial Authorization (CTA) acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to run a first-in-human Phase I trial with Entervax\u2122, a bivalent vaccine against enteric fever. Prokarium anticipates…<\/p>\n","protected":false},"author":4,"featured_media":1545,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[36],"tags":[],"class_list":["post-1602","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"\n