hVIVO reports positive results from the Phase IIb field study of FLU-v (FLU-v 003) representing a significant advance in the management of influenza disease
· Primary and secondary endpoints achieved – induction of long-lasting T and B cell immunological responses
· Reduction in influenza infection rates and severity and duration of symptoms observed
· Treatment with FLU-v was well tolerated with an adverse event profile consistent with earlier studies
· Based on the results of two Phase IIb trials and previous studies, FLU-v is now ready for Phase III development
· FLU-v product profile is a broad spectrum (A, B and Pandemic strains), stand-alone, single injection influenza vaccine providing long-lasting protection and significant reduction in influenza symptoms and their severity
· By overcoming a number of key issues with current annual influenza vaccines it has the potential to address a much larger patient population and therefore has future blockbuster sales potential
Webcast and conference call for analysts at 1pm BST today – see details below
London, UK, 18 June 2018: hVIVO plc (AIM: HVO), a pioneer of human disease models and an industry leading clinical development services business, today announces positive results from a second Phase IIb study of FLU-v, (Study 003, NCT02962908).
FLU-v is being developed by Imutex Limited, hVIVO’s 49% joint venture with the SEEK Group.
Trevor Phillips, executive chairman of hVIVO PLC (LON:HVO), caught up with Proactive Investors
Trevor Phillips, Executive Chairman of hVIVO, said: “We are pleased that a second Phase IIb study has reported positive results for FLU-v. 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. Along with our joint venture partner SEEK, and with a differentiated data-package, we will endeavour to maximise the strategic options available to the Company from FLU-v while still focusing on our other revenue streams.”
Gregory Stoloff, Chief Executive Officer of SEEK, said: “The disease and symptom reduction seen with this “universal” influenza vaccine candidate is achieved by stimulating an immune response mediated through T&B-cells to internal conserved influenza proteins, in contrast to seasonal influenza vaccines that prevent infection through antibody protection against external variable proteins. FLU-v is a synthetic polypeptide vaccine which means that it is not reliant on traditional manufacturing techniques with inherent risks, in particular the potential of a miss-match of virus particularly relevant for a pandemic strain. FLU-v is designed to protect against a broad range of influenza viral strains and this includes unexpected seasonal strains or a potentially devastating pandemic strain.”
Dr. P.H.P. Groeneveld, Principal Investigator for FLU-003 study, Isala Hospitals, 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.”
Webcast and conference call for analysts at 1pm BST today
Trevor Phillips, Executive Chairman, Tim Sharpington, Managing Director R&D joined by Greg Stoloff, Chief Executive Officer of SEEK Group, will host a live conference call and webcast for analysts at 1pm BST today, 18 June 2018, to discuss this announcement. Please visit hVIVO’s website approximately 10 minutes before the conference call to download the presentation slides.
The presentation and access to the live webcast will be on hVIVO’s website at www.hvivo.com. An audio replay file will be made available shortly afterwards via hVIVO’s website.
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