26th Mar 2018 15:05
FLU-v is being developed by Imutex Ltd, hVIVO's 49% joint venture with PepTcell Ltd, trading as the SEEK Group.
Preliminary analysis of the primary endpoint revealed a trend to statistical significance, with "further testing of samples ongoing that could affect the final outcome".
The primary endpoint, a novel composite score combining the occurrence of one symptom of flu-like illness and changes in viral load, trended to statistical significance in the single FLU-v dose arm versus placebo when using qPCR to determine viral load.
In addition, the study demonstrated a statistically significant reduction in overt flu symptoms in treated subjects in one arm of the trial.
"While we note the preliminary determination that the primary endpoint only trended to statistical significance, we are mindful of the prespecified additional analysis being conducted by the NIH, that may have an impact, before opining conclusively. That said, the symptom reduction data we have seen in this study with FLU-v is incredibly exciting and consistent with this universal flu vaccine candidate's putative mechanism of action," said hVIVO Chief Executive Kym Denny.
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