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news.Renovo Group has received positive feedback on its proposed European Juvista Phase III clinical program from the EMEA's Committee for Medicinal Products for Human Use.
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The European Medicines Agency (EMEA) agreed to Renovo performing two pivotal double blind, within patient, placebo controlled Phase III trials in scar revision surgery to establish efficacy. In addition Renovo will undertake a separate parallel group design safety study with a six month endpoint using the higher of the two doses planned.
In its advice the EMEA indicate that an acceptable primary endpoint is an assessment of standardized photographs of drug and placebo treated scars from the same patient by an independent clinical expert panel, 12 months following surgery. This improvement is to be measured using a new Global Scar Comparison Scale which has been developed and validated by Renovo. Other secondary endpoints include a patient based assessment of scar improvement, and an on the patient assessment by the investigating surgeon.
Following this advice and as planned Renovo intends to commence its first European Phase III efficacy trial in scar revision surgery in the second half of 2008. This trial will evaluate two doses of Juvista (200ng and 500ng per 100µl per linear cm of wound margin) given twice, following wound closure and 24 hours later, to a total of 350 patients. No further Juvista clinical data are required before commencing this trial or the rest of the Phase III program.