November, 2010 -- Renovo Group plc (LSE : RNVO), the biopharmaceutical company developing drugs to reduce scarring, improve wound healing and enhance tissue regeneration, today announces a successful outcome of
its clinical trial designed to establish the safety and efficacy of a new formulation (Juvista Paediatric)
of Juvista intended for use in children. The trial met its primary endpoint: once dosing (at the time of
wound closure) with Juvista Paediatric statistically significantly improved the appearance of the
subsequent scars when compared to placebo (p<0.0001). The trial also met a number of secondary
endpoints including confirming that for the existing adult formulation of Juvista used in the ongoing
EU Phase III trial the 500ng/100ìL/linear cm of wound margin dose produces the most significant
improvement in scar appearance compared to placebo treatment (p<0.0001).
- 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 III trial).
- Single doses of Juvista Paediatric administered immediately after wound closure (500 and
1000 ng/100ìl/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/100ìl/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 III efficacy study (500
ng/100ìl/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 /100ìl/linear cm of wound margin, either once
- From a questionnaire designed to elucidate different characteristics of the scars after 12
months, subjects identified scar width and scar colour as the features most improved by
administration of Juvista or Juvista Paediatric, particularly by the twice dosing regimens.
- There were no untoward safety findings, the most common adverse events recorded were
nasopharyngitis (14%), upper respiratory tract infection (13%) and headache (8%) as
expected in a population of healthy people monitored over time. As previously observed,
administration of Juvista or Juvista Paediatric may be associated with transient erythema and
oedema at the site of injection, compared to placebo.
Professor Mark WJ Ferguson, CEO, Renovo Group plc commented “This trial has been extremely
successful. Not only have we established that we have a new formulation that is suitable for further
evaluation in children, ideally as a single administration, but we have also reconfirmed that the
500ng/100ìl/linear cm of wound margin dose of Juvista in our ongoing EU Phase III trial (REVISE) was
appropriately selected as it demonstrated the greatest level of efficacy”.
The first Juvista EU Phase III trial in scar revision surgery is fully recruited (more than 350 patients)
and should report data in H1 2011.
For further information please contact:
Prof Mark Ferguson, CEO +44 (0) 161 276 7121
David Blain, CFO +44 (0) 161 276 7113
Tim Anderson / Lisa Baderoon / Catherine Breen +44 (0) 20 7466 5000