Lancet Publication of Juvista (INN: Avotermin) Trial Results for the Improvement of Skin Scarring

LONDON, April 10, 2009--Renovo Group plc (LSE: RNVO), the biopharmaceutical company developing drugs for the reduction of scarring and acceleration of healing, announces the recent publication in The Lancet (11 April 2009, vol 373, pages 1264-1274) of Juvista (avotermin) trial results from three statistically significant, double-blind, placebo-controlled phase I/II studies (1002, 1005 and 0036) for the improvement of skin scarring. 

This publication provides detailed data from three statistically significant trials which demonstrate that Juvista (avotermin) treatment results in scars which resemble more closely normal skin, in both appearance and structure, compared to either placebo or standard care treatments.

A commentary on the publication is provided in the same issue of The Lancet by Dr Edward E Tredget, Professor of Plastic Surgery at the University of Alberta, who highlights the promise of this pioneering work for the future treatment of a range of fibrotic disorders.

The studies were conducted by Renovo and Juvista (avotermin) is now in Phase 3 development in Europe, with the first EU trial due to report in the first half of 2011.
Professor Mark WJ Ferguson, CEO of Renovo, commented:
“We are very pleased to see these trial results published in The Lancet.  Juvista (avotermin) is a new class of prophylactic medicine that promotes the regeneration of healthy skin and improves scar appearance.

“With low doses injected locally around the time of surgery, Juvista (avotermin) is a generally well tolerated and convenient treatment. These studies demonstrate that Juvista (avotermin) has potential to provide an accelerated and permanent improvement in scarring.”

For further information, please contact:
 
Renovo Group plc
 
Prof Mark Ferguson, CEO
+44 (0) 161 276 7121
Simon Bielecki, Vice President, Communications
+44 (0) 161 276 7142
 
 
Buchanan Communications
 
Mary-Jane Johnson/Tim Anderson/Catherine Breen
+44 (0) 20 7466 5000


SUMMARY

Reproduction of the summary from The Lancet 2009; 373; 1264-1274 ‘Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled phase I/II studies’ Mark W J Ferguson, Jonathan Duncan, Jeremy Bond, James Bush, Piyush Durani, Karen So, Lisa Taylor, Jonquille Chantrey, Tracey Mason, Gaynor James, Hugh Laverty, Nick L Occleston, Abdul Sattar, Anna Ludlow, Sharon O’Kane

Background Research into mechanisms of skin scarring identified transforming growth factor β3 (TGFβ3) as a potential antiscarring therapy. We assessed scar improvement with avotermin (recombinant, active, human TGFβ3).

Methods In three double-blind, placebo-controlled studies, intradermal avotermin (concentrations ranging from 0•25 to 500 ng/100 μL per linear cm wound margin) was administered to both margins of 1 cm, full-thickness skin incisions, before wounding and 24 h later, in healthy men and women. Treatments (avotermin and placebo or standard wound care) were randomly allocated to wound sites by a computer generated randomisation scheme, and within-participant controls compared avotermin versus placebo or standard wound care alone. Primary endpoints were visual assessment of scar formation at 6 months and 12 months after wounding in two studies, and from week 6 to month 7 after wounding in the third (total scar score). Investigators, participants, and scar assessors were blinded to treatment. Efficacy analyses were intention to treat. These studies are registered with ClinicalTrials.gov, numbers NCT00847925, NCT00847795, and NCT00629811.

Results In two studies, avotermin 50 ng/100 μL per linear cm significantly improved median score on a 100 mm visual analogue scale (VAS) by 5 mm (range –2 to 14; p=0•001) at month 6 and 8 mm (–29 to 18; p=0•0230) at month 12. In the third, avotermin significantly improved total scar scores at all concentrations versus placebo (mean improvement: from 14•84 mm [95 % CI 5•5–24•2] at 5 ng/100 μL per linear cm to 64•25 mm [49•4–79•1] at 500 ng/100 μL per linear cm). Nine [60%] scars treated with avotermin 50 ng/100 μL per linear cm showed 25% or less abnormal orientation of collagen fibres in the reticular dermis versus five [33%] placebo scars. After only 6 weeks from wounding, avotermin 500 ng/100 μL per linear cm improved VAS score by 16•12 mm (95% CI 10•61–21•63). Adverse events at wound sites were similar for avotermin and controls. Erythema and oedema were more frequent with avotermin than with placebo, but were transient and deemed to be consistent with normal wound healing.

Interpretation Avotermin has potential to provide an accelerated and permanent improvement in scarring.

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 Juvista Phase 3 efficacy trial has commenced in the EU.

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. Renovo will commence a Phase 2 trial for Juvidex in the reduction of scarring in tendons in 2009. In addition Renovo has an extensive preclinical pipeline.

For further information on Renovo please visit: www.renovo.com

 

Posted: April 2009

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