Shaun Chilton – CEO, Clinigen Group, UK
A British success story, Clinigen Group provides companies with services in portfolio and product lifecycle management on a global basis. Its CEO, Shaun Chilton, talks to us about the value…
Address: Core Technology Facility
48 Grafton Street
Manchester
M13 9XX
,United Kingdom
Tel: +44 (0) 161 276 7100
Renovo is a biopharmaceutical product company and a leader in the discovery and development of drugs to reduce scarring, improve wound healing and enhance tissue regeneration.
In a comprehensive programme of Phase I/II clinical trials Renovo’s lead drug, Juvista, has demonstrated statistically significant results in improving the appearance of scars in the skin, which alone represents a multi-million dollar market of unmet medical need.
Renovo aims to be first to market with a pharmaceutical drug in the US and Europe to prevent and reduce scarring. There are currently no approved pharmaceuticals available in the US or Europe for this purpose.
Renovo has an exceptional team of highly experienced and innovative scientists and clinicians. Based in Manchester, UK, at the heart of a thriving centre for pharmaceutical research, Renovo has built a portfolio of drugs that have reached phase 2 and phase 3 of clinical development, as well as a rich pipeline at all stages of pre-clinical R&D.
A high performance culture of innovation as well as scientific and clinical excellence has allowed Renovo to pursue pioneering programmes of drug discovery and development in the rapidly evolving fields of scar prevention, wound healing and tissue regeneration. Renovo has its own fully staffed Clinical Trials Unit and a productive development team focussed on wound and scar biology, pharmacology, genomics and proteomics.
Juvista (INN: Avotermin – an intradermal injectable solution of Transforming Growth Factor Beta 3 (TGFβ3)), Renovo’s lead drug for the improvement of scar appearance in the skin, has been studied in an extensive early phase development programme in the EU, involving around 1,600 subjects. Efficacy, safety and dose response has been evaluated in statistically powered trials in both normal volunteers and patients, and following scientific advice from EMEA, a phase III programme for the EU has been agreed and initiated. The first EU Phase 3 trial was unsuccessful. The project is under review.
Prevascar (an intradermal injectable solution of human recombinant Interleukin 10) previously reported a positive exploratory efficacy trial for the reduction of scarring in the skin. Following improvements in the manufacturing of Prevascar drug substance and product, and identification of a clinical cohort who are predicted (on the basis of a non-drug experimental surgery study) to benefit particularly well from Prevascar’s modulating effect on the wound inflammatory response, Renovo has commenced a new proof of concept clinical trial in skin excisions and excisions in African-ancestral group human volunteers and is due to report interim data in H1 2011.
Adaprev an injectable solution of Mannose-6-Phosphate (M-6-P)) is being developed by Renovo as a Class III medical device in the EU for the prevention of adhesions (scar tissue) between tendon and tendon sheath, and the improvement of tendon function in patients undergoing surgical repair of flexor tendons in the hand. The first randomised, double-blind, standard care controlled, clinical trial commenced in November 2009 and is due to report in H2 2011.
Juvidex (topical application of Mannose-6-Phosphate (M-6-P)) reported statistically significant improvements in pre-specified endpoints of skin appearance and acceleration of healing in a proof of concept clinical trial. Renovo intends to partner Juvidex as a cosmetic ingredient, and is actively seeking a suitable partner to ensure its rapid development and commercialisation.
The development towards the clinic of RN1005, a promising pre-clinical candidate pharmaceutical (discovered by Renovo), targeting the Wnt pathway for reduction of scarring and stimulation of tissue regeneration has been greatly assisted by financial grants from the Government’s Technology Strategy Board (TSB) and the Knowledge Transfer Partnership.
A British success story, Clinigen Group provides companies with services in portfolio and product lifecycle management on a global basis. Its CEO, Shaun Chilton, talks to us about the value…
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