Renovo Group plc announced positive results in a clinical trial designed to establish the safety and efficacy of a new formulation of the scar revision drug Juvista intended for use in children. The study of Juvista Paediatri included 84 patients and the statistical analysis (p<0.0001) indicated a profound result much more than the hurdle rate of 21% improvement set in the phase 3 trial.
Highlights of the announcement include:
• 84 healthy male and female subjects participated in a double blind, placebo controlled, within subject comparative study of the safety and efficacy of Juvista and Juvista Paediatric on scar appearance after 12 months using the Global Scar Comparison Scale (the primary endpoint agreed with the EMA for Renovo’s ongoing EU Phase 3 trial).
• Single doses of Juvista Paediatric administered immediately after wound closure (500 and 1000 ng/100?l/linear cm of wound margin) significantly improved the appearance of surgical 1cm incision scars compared to placebo (p<0.0001) when assessed by an expert panel using the Global Scar Comparison Scale at 12 months.
• Statistically significant improvements were also observed for single doses of Juvista Paediatric (500 and 1000 ng/100?l/linear cm of wound margin) for the investigator’s assessment directly on the patient at 12 months using the Global Scar Comparison Scale (p<0.001, p<0.0001 respectively).
• The current top dose of Juvista in the ongoing adult EU Phase 3 efficacy study (500 ng/100?l/linear cm of wound margin administered twice) was re-confirmed as the optimal dose for improvement of scar appearance (p<0.0001) as no further efficacy (in fact a slight decrease) was achieved after dosing 1000ng /100?l/linear cm of wound margin, either once or twice.
Date: November 23, 2010
Source: Renovo Group plc
