RENOVO GROUP PLC (“Renovo” or “the Company”) ADAPREV™ TRIAL COMMENCES: FIRST PATIENT TREATED Renovo Group plc (LSE: RNVO), the biopharmaceutical company developing products for the reduction of scarring, today announces the enrolment and treatment of the first patient in its trial to evaluate the safety, tolerability and preliminary performance of Adaprev in improving recovery of tendon function in patients undergoing surgical repair of flexor tendons in the hand.
The trial, which commenced on schedule, is a randomised, double-blind, standard care controlled study in 44 male and female patients being conducted in ten UK centres and is due to report in the first half of 2011.
Renovo is developing Adaprev as a Class III medical device (i.e. a device with ancillary pharmacological action). As clinical development programmes for medical devices tend to be simpler compared to pharmaceuticals, with fewer trials and numbers of patients required, this should provide Renovo with a faster route to market for Adaprev.
Assuming this first trial is successful Renovo anticipates that it will need to undertake one further trial for Adaprev prior to seeking regulatory approval.
For further information please contact:
Renovo Prof Mark Ferguson, CEO +44 (0) 161 276 7121
Buchanan Communications Tim Anderson / Lisa Baderoon / Catherine Breen +44 (0) 20 7466 5000
About Renovo Group plc
Renovo is a biopharmaceutical product company and a leader in the discovery and development of drugs to improve the appearance of scars. Juvista (INN: avotermin), Renovo’s lead drug for the reduction of scarring in the skin, has been generally well tolerated by around 1,500 human subjects and has provided statistically significant efficacy data in eight Phase 2 double blind, placebo controlled efficacy trials. The first EU Juvista Phase 3 efficacy trial in scar revision surgery is recruiting and is on track to report in the first half of 2011.
Renovo announced in June 2007 that it had signed an exclusive licensing agreement with Shire plc to develop and commercialise Juvista. The agreement covers every country in the world except the European Union, the rights to which have been retained by Renovo. Under the terms of the deal Renovo has already received an initial upfront payment of US$75 million and an equity investment of US$50 million. Contingent on the successful development and commercialisation of Juvista Renovo will be eligible for further payments of up to $700 million together with escalating royalties on sales.
Prevascar® reported statistically significant Phase 2 efficacy data for the reduction of scarring in the skin and is in formulation optimisation to further enhance efficacy. Renovo has now commenced a trial for Adaprev™ in the reduction of scarring in tendons.
Following a positive proof of concept clinical trial, Juvidex is being developed as a cosmetic for the improvement of skin appearance and acceleration of healing (eg following chemical peel or laser resurfacing procedures).