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Publication of positive results in journal
Publication of positive results in journal.
About this update from Hvivo Plc
[{"type":"text","content":"\n \n \n RNS Number : 1759G\n Open Orphan PLC\n 16 March 2020\n \n \n \n RNS REACH\n \n Open Orphan plc\n (\"Open Orphan\" or the \"Company\")\n \n Positive results from\n \n FLU-v vaccine challenge study (FLU-v 004), the second Phase IIb study of\n \n \n \n FLU-v, which has been developed by Imutex Limited, hVIVO's 49% joint venture with the SEEK Group, have now been published in a peer review journal \n \n \n \n \n \n FLU-v is a first-in-class 'universal', broad spectrum, standalone, influenza vaccine candidate\n \n \n · \n The publication in 'npj Vaccines' reported that one dose of FLU-v induced statistically significant reduction in mild to moderate influenza disease (MMID) defined as detection of viral shedding with at least one influenza symptom - reduction in confirmed influenza and symptoms\n \n \n · \n One dose of FLU-v also induced a statistically significant reduction in the number of subjects experiencing 2 or more influenza symptoms compared to placebo\n \n \n · \n This report follows recent publication of positive FLU-v Phase IIb field study results (FLU-v 003) demonstrating cellular and humoral immunogenicity of a single dose of adjuvanted FLU-v in 175 individuals\n \n \n · \n The npj Vaccines article concludes that the T-cell strategy employed by FLU-v has potential to offer protection against influenza infection as a vaccine and that larger studies can evaluate how the vaccine interacts with influenza strains in different cohorts\n \n \n · \n Imutex is currently scheduling meetings with key regulatory authorities, FDA and EMEA, hoping to gain confirmation of the remaining development pathway to approval for FLU-v\n \n \n \n \n 16 March 2020:\n \n \n Open Orphan plc (ORPH),\n the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services\n \n , today announces publication of positive results of a Phase IIb challenge study of FLU-v 004 \n (Study 004, NCT03180801) in \n npj Vaccines. The headline results from this study were previously announced by hVIVO on 10 January 2019. FLU-v is being developed by Imutex Limited, hVIVO's 49% joint venture with PepTcell Limited, trading as the SEEK Group (\"SEEK\").\n \n The primary endpoint was achieved in the Phase II...