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news.Renovo, a biopharmaceutical product company, has completed patient recruitment into its first EU Phase III trial of Juvista for the improvement in scar appearance of disfiguring scars following scar revision surgery.
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Renovo said that the trial has now recruited over 350 patients from 55 centres in 10 countries: UK, France, Hungary, Germany, Italy, Poland, Spain, Denmark, Latvia and USA.
Reportedly, the primary endpoint for the trial is a clinical panel assessment of standardised photographs at 12 months after surgery, assessed for scar improvement by the Global Scar Comparison Scale.
Following the last patient visit at 12 months post surgery, the standardised photographs will be prepared, scored by an independent Clinical Panel and the data analysed, which means that Renovo is on schedule to report the results of this trial in H1 2011, as previously guided.
Renovo reconfirmed that when the first Juvista EU Phase III trial reports in H1 2011 it expects to have a cash balance of GBP25 – 30m, and that it has the possibility of licensing Juvista in all countries of the world, except USA, Mexico and Canada, which are licensed to Shire.
Mark Ferguson, CEO of Renovo Group, said : “I am delighted that the first EU Phase III trial of Juvista is fully recruited, on schedule, and we look forward to the results in H1 2011.”