Renovo Group plc (LSE: RNVO), the biopharmaceutical company developing drugs to reduce scarring, improve wound healing and enhance tissue regeneration today announces that its first EU Phase III trial for Juvista in scar revision surgery (REVISE(TM)) did not meet its primary or secondary endpoints. Renovo will conduct further exploratory analysis and determine the future of the Juvista development programme.
Professor Mark Ferguson, CEO Renovo, said: "We are extremely surprised and disappointed by the failure of Juvista to meet the Phase III trial primary and secondary endpoints. The Board of Renovo will now consider all options open to it to maximise shareholder value."
As at 11th February 2011 the Company had cash reserves of approximately GBP44million.
For further information please contact: Renovo Prof Mark Ferguson, CEO +44 (0) 161 276 7121
David Blain, CFO +44 (0) 161 276 7123
Buchanan Communications Tim Anderson / Lisa Baderoon +44 (0) 20 7466 5000
Information in this announcement is based upon unaudited management accounts and in addition, certain statements made are forward looking statements. Such statements are based on current expectations at the date of this announcement and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially from any expected future events or results referred to in these forward looking statements. We undertake no obligation to update or revise any forward-looking statements to reflect any change in our expectations or any change in events, conditions or circumstances.
The REVISE Trial
This was a double blind, within patient, placebo controlled trial to assess the efficacy of two dose levels of Juvista (200ng and 500ng/100ul/linear cm of wound margin) given twice, following wound closure and 24 hours later, on the appearance of scars following scar revision surgery. Over 350 patients were recruited from 56 centres in UK France, Hungary, Germany, Italy, Poland, Spain, Denmark, Latvia and USA. The EMA agreed primary endpoint for efficacy was a photographic based assessment at 12 months following surgery by an independent panel of experts using the Global Scar Comparison Scale. Secondary endpoints included an assessment of the scars using the Global Scar Comparison Scale by the patients themselves and by the clinical trial investigator. None of the primary or secondary endpoints were met for either dose.
About Renovo Group plc
Renovo is a London Stock Exchange listed biopharmaceutical product company and a leader in the discovery and development of drugs to reduce scarring improve wound healing and enhance tissue regeneration. For further information on Renovo please visit: www.renovo.com