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Renovo Group Plc Announces Successful Juvista(R) Trial


11/23/2010 11:49:53 AM

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).

Study Highlights:

- 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 or twice.

- 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:

Renovo Prof Mark Ferguson, CEO +44 (0) 161 276 7121 David Blain, CFO +44 (0) 161 276 7113 Buchanan Communications Tim Anderson / Lisa Baderoon / Catherine Breen +44 (0) 20 7466 5000


Read at BioSpace.com

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