Renovo fully recruited on Phase III trials
Friday, April 30th
Juvista EU Phase III Trial Fully Recruited and On Schedule to Report Data in H1 2011
Renovo Group plc, the biopharmaceutical product company developing drugs to reduce scarring, improve wound healing and enhance tissue regenration, announced on 29 March that in the first quarter of 2010 it completed recruitment into its first EU Phase III trial of Juvista for the improvement in scar appearance of disfiguring scars following scar revision surgery.
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.
The primary endpoint for this 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 held a meeting with many trial investigators at the International Scar Conference in Montpellier, France 25-27 March 2010, the programme of which featured a number of presentations by Renovo staff and Clinical Investigators of previous and ongoing Renovo clinical trials (No new material information was presented).
Renovo reconfirms that when the first Juvista EU Phase III trial reports in HI 2011 it expects to have a cash balance of £25-30M, and that it has the possibility of licensing Juvista in all countries of the worls, except USA, Mexico and Canada, which is licensed by Shire.
Professor Mark Ferguson, CEO of Renovo Group plc commented: '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'.
