Business
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 : 5166F\n Open Orphan PLC\n 10 March 2020\n \n \n \n \n Open Orphan plc\n (\"Open Orphan\" or the \"Company\")\n \n \n Positive results from\n \n Phase IIb field study of FLU-v vaccine (FLU-v 003), which has been developed by Imutex Limited, hVIVO's 49% joint venture with the SEEK Group. FLU-v is a first-in-class 'universal', broad spectrum, standalone, influenza vaccine candidate and the results have now been published in a peer review journal\n \n \n \n \n · \n The publication in the Annals of Internal Medicine journal concluded adjuvanted FLU-v is immunogenic and merits Phase III development to explore efficacy\n \n \n · \n Compelling data package from two Phase II studies shows that a single dose of adjuvanted FLU-v induces cellular and antibody responses (FLU-v 003) and that it has a clinical impact in reducing disease, symptom and viral load (FLU-v 004)\n \n \n · \n Imutex 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 10 March 2020: Open Orphan plc (ORPH) 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, today announces publication of positive results of a Phase IIb field study of FLU-v 003 (Study 003, NCT02962908) in the Annals of Internal Medicine journal. The headline results from this study were previously announced by hVIVO on 18 June 2018. FLU-v is being developed by Imutex Limited, hVIVO's 49% joint venture with the SEEK Group. \n \n The Primary and secondary endpoints were achieved in a Phase IIb study, done within the UNISEC* Consortium and funded by the European Commission under the Seventh Framework Programme for Research and Technological Development (FP7). 175 healthy adults were randomly assigned to either an\n injection of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v or adjuvanted or nonadjuvanted placebo to compare the safety, immune response, and exploratory efficacy of different formulations and dosing regimens. They found that \n a single dose of adjuvanted FLU-v elicited a greater immune response compared with placebo. Adverse events were mostly mild to moderate injection site reaction...