Blockbuster sale25 Jul 2018 11:51
ositive Results for Phase IIb FLU-v Field Study
Mon, 18th Jun 2018 07:00
RNS Number : 6367R
hVIVO plc
18 June 2018
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hVIVO plc
("hVIVO" or the "Company")
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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
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·     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
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Webcast and conference call for analysts at 1pm BST today - see details below
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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).
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FLU-v is being developed by Imutex Limited, hVIVO's 49% joint venture with the SEEK Group.
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Trevor Phillips, Executive Chairman of hVIVO, said:Â "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.
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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."
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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 stra
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