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hVIVO soars on trial success for universal influenza vaccination
hVIVO on Monday confirmed it has seen positive final results from its clinical trial of the safety and efficacy of two formulations and dosing regimens of FLU-v vaccine administered in healthy adults.
The biopharma company said a single dose of FLU-v was shown to induce the strongest response rates, with this group experiencing a 60% reduction in confirmed influenza infections and an 83% reduction in the number of confirmed cases with severe symptoms compared to the placebo group.
The results stem from the FLU-003 study a randomised, double-blind, placebo-controlled, single-centre trial which was part of an EU-funded European Universal Influenza Vaccines Secured Consortium (UNISEC) project.
The study showed "significant" increases in T-Cell responses and the FLU-v specific antibody, immunoglobulin, responses in vaccinated subjects compared to those from the placebo group.
Trevor Phillips, executive chairman of AIM-listed hVIVO, said: "It is our view that FLU-v is now positioned to enter phase III, with clear disease and symptom-based endpoints identified. The market potential for a broad spectrum universal influenza vaccine is significant."
The vaccine is intended to be universal, and provide more protection against pandemic flu than current vaccinations that have to be updated every year.
Current vaccinations are rolled out in a limited number due to their high manufacturing costs and annual nature, leading hVIVO to conclude that a successful universal vaccine would be see "blockbuster" sales.
PHP Groeneveld, principal investigator for FLU-003 study, Isala Hospitals, in the Netherlands, said: "The broad spectrum late stage-development FLU-v vaccine is a promising step in the battle against influenza. It has shown to induce very potent Th1 immune response to influenza proteins that could reduce infections and severe symptoms."
As if 0832 BST, hVIVO's shares were up 26.62% at 24.94p.