FURTHER POSITIVE PHASE II CLINICAL TRIAL RESULTS FOR JUVISTA AND PIPELINE UPDATE Renovo Group plc (LSE: RNVO), the biopharmaceutical company developing drugs for the prevention and reduction of scarring at multiple body sites, is today giving an update on its drug pipeline. As part of this update Renovo is pleased to announce positive Phase II clinical trial results for its lead drug, Juvista, in a 12 month proof of concept study of scar reduction in split thickness skin graft donor sites (trial 1007). A briefing for analysts and investors will be presented by Professor Mark Ferguson, CEO of Renovo Group plc, at 10.00am today at the offices of Buchanan Communications, 45 Moorfields, London, EC2Y 9AE. Juvista Juvista is a therapeutic application of human recombinant TGFβ3 which has been shown in clinical trials to markedly improve subsequent scar appearance in the skin. As indicated at flotation, Renovo has now reported the results of two Phase II studies (1007 & 1011) in the second half of 2006. Both trials delivered statistically significant efficacy results. Clinical Trial 1007 – split thickness skin graft donor sites
- Statistically significant reduction in scarring in Juvista treated split thickness skin graft donor sites compared to placebo (p=0.03)
- 12 month study indicates a permanent improvement of scar appearance
- Effective given as an injection followed by topical application at the time of surgery and topical application one day later
- This proof of concept study is the first time Juvista has been administered to open wounds (split thickness skin graft donor sites) and is in contrast to previous trials in incisional wounds closed by suture or steri strips
- Continued excellent safety and tolerability profile
Clinical trial 1007 was a fully randomised, double-blind, placebo controlled Phase II study designed to investigate the safety, tolerability, systemic exposure, and anti-scarring potential of Juvista in split thickness skin graft donor sites. Clinical assessment by plastic surgeons at 12 months following administration of Juvista demonstrated a statistically significant reduction in scarring compared to placebo (p= 0.03) and indicated a permanent regeneration of more normal skin. This trial demonstrates, for the first time, the efficacy of Juvista in the reduction of scarring in large open wounds whose margins are not approximated and sutured. These wounds are more easily treated with a topical application of Juvista rather than injection which is ideal for sutured wounds. Development of a topical formulation of Juvista would offer the prospect of additional indications such as reducing scarring in split thickness skin graft donor sites, grafts and burns which are markets of high medical need. Juvista injection for closed wounds following incisions/excisions however, remains Renovo’s primary target market as this represents the vast majority of surgical procedures each year (estimated to be at least 42 million procedures per year in the USA alone). Clinical Trial 1011 – incisional wounds In September this year Renovo announced highly statistically significant results (p<0.0001) from clinical trial 1011. The findings from this trial are particularly relevant to the major market of scar reduction following surgery and wound closure. Trial 1011 demonstrated that scars from incisional wounds injected with 200ng/100uL/linear cm of Juvista given either once or twice show a marked improvement in appearance compared to placebo. This was first evident at 4-7 months and was maintained or further improved at 12 months, indicating a permanent regeneration of more normal skin. These two new positive clinical trial results (1007, 1011) build on previous positive Renovo Phase II trial results presented at the time of IPO. Ongoing trials Trials for breast augmentation (1010) and mole removal (1008) are fully recruited, in follow-up phase and due to report in 2008. Scar revision trial (1009) started in H1 2006. A multicentre trial in breast reduction (0041) was initiated in the first half of 2006. Two trials confirming the dose response with Cambrex manufactured TGFβ3 have also started: trial 0050 has fully recruited and the follow-on trial 0036 is in mid-recruitment. Planned trials to support the fast track indication of surgical revision of disfiguring scars A fast track application has recently been submitted to the FDA with a protocol for a pilot study of scar prevention following keloid excision. This is anticipated to be Renovo’s first trial in the United States. To provide potential partners with an opportunity to contribute to protocol design of a large multinational series of scar revision trials (0060-0063) which are strategically important and expensive, Renovo has decided to slightly delay initiation of this set of trials until the first half of 2007, after a partnering deal is likely to have been concluded. As a result of this strategy a rolling BLA (Biologics License Application) submission for the indication of the surgical revision of disfiguring scars is anticipated to commence in 2007 and conclude with the clinical dossier in H1 2009. Planned trials to support the general (cosmetic) indication of scar improvement Trials for breast augmentation (1010) and mole removal (1008) are fully recruited, in follow-up phase and due to report in 2008. The clinical trial for the prevention of scarring following bilateral varicose vein surgery (0042) has started in the UK, which is scheduled to recruit the majority of patients. Centres in the United States, where the operation is less common, may be added in H1 2007 after the results of a pre-clinical study have been reported to the FDA. Phase III trials for the general scar reduction indication are scheduled to begin in H2 2007 and are currently planned to be for the prevention of scarring following mole removal and breast augmentation surgery (pending end of Phase II discussions with the regulatory authorities). BLA submission for the broader general scar reduction label remains on track for 2009. Zesteem Zesteem is a novel formulation of estradiol and accelerates re-epithelialisation following surgery or wounding. The first Phase III clinical trial in split thickness skin graft donor sites (0066) will be initiated in H2 2006. Juvidex Juvidex, a formulation of Mannose-6-Phosphate (M6P), inhibits the activation of TGFβ1 and TGFβ2 resulting in an improvement of subsequent scarring. The current Phase II efficacy trial in the skin will report in H2 2006. Juvidex will likely be differentiated for prevention of scarring in indications outside the skin. Initial clinical trials will likely focus on the eye or tendons and will commence at the end of 2007 or beginning of 2008. Prevascar Prevascar is a formulation of human recombinant Interleukin 10 (IL-10) which modulates the inflammatory response resulting in an improvement in subsequent scarring. The current Phase II efficacy trial in the skin will report in H1 2007. An initial clinical trial for the prevention of scarring following nerve injury is being planned. Preclinical Renovo continues to discover new molecules and targets and to file appropriate patent applications. Commenting on Renovo’s pipeline and today’s new clinical trial data, Professor Mark Ferguson, Chief Executive Officer, said: “We are extremely pleased with the progress we’ve made on our pipeline. Today’s new clinical trial data (1007) for Juvista provides us with statistically significant efficacy data using a proof of concept topical administration to split thickness skin graft donor sites – potentially opening up an additional new market opportunity for us in open wounds, for example following burn injury. “These positive data for split thickness skin graft donor sites follow our recent announcement of highly statistically significant results from Trial 1011 where Juvista improved the scar appearance following surgical incisions. These two positive trials further support the statistical and clinical effectiveness of Juvista in the reduction of scarring. “This quarter we have delivered two more positive trial results for Juvista and made excellent progress in our goal to be first to market with a drug to reduce scarring in the skin.” Today’s web cast Simultaneous with the meeting at 10.00 am, there will be a live audio web cast of the presentation. To connect to the web cast facility, please go to the Company’s website www.renovo.com approximately 10 minutes (09:50 am) before the start of the briefing. Preliminary results Renovo will announce its preliminary results for the year ending 30 September 2006 on 14 December 2006. For further information please contact: Renovo Group plc Professor Mark Ferguson, Chief Executive Officer +44 (0) 161 606 7222 Simon Bielecki, Head of Communications +44 (0) 161 606 7328 Buchanan Communications Tim Anderson/Lisa Baderoon/Mary-Jane Johnson +44 (0) 20 7466 5000 Trial 1007 background This trial (1007) was a fully randomised, double-blind, placebo controlled Phase II study to investigate the safety, toleration, systemic exposure, and anti-scarring potential of Juvista in split thickness skin graft donor sites in 97 male subjects aged 18-85 years. The within person trial design used a placebo or standard care control compared to a 50ng/cm² injection of Juvista or 50ng/cm² injection plus 100ng/cm² topical application of Juvista. Subjects were assigned to one of three groups. Each subject had two 3cm² split thickness skin graft donor sites harvested using a dermatome from the lower back. Split thickness skin graft donor sites were randomly assigned to Juvista or placebo treatment. Clinical assessment of scarring of the donor sites at 12 months showed the Juvista treated sites (injection and topical) to be statistically significantly improved compared to placebo. About Renovo Renovo is a biopharmaceutical product company and is the world leader in scar prevention and reduction research, and the development of drugs to prevent and reduce scarring. The Company has a highly skilled management team with over 30 years of research in the field of scarring, and significant pharmaceutical industry experience. Renovo has a portfolio of drugs which exploit different novel mechanisms of action to prevent and reduce scarring at multiple body sites and to accelerate healing. The Company’s deep pipeline includes four drugs in phase II clinical development, a further four advanced pre-clinical candidates and nine other pre-clinical candidates. Scarring can result from acute injury in, or surgery to, the skin, blood vessels, eyes, nerves, internal organs, tendons and ligaments. These are high value markets of significant unmet medical need. Renovo aims to be first to market with a pharmaceutical drug in the US and Europe to prevent and reduce scarring. Current demand is inadequately met and there is no near term competition. According to external research conducted by The Mattson Jack Group, the potential commercial market for prevention and reduction of scarring in the skin is worth in the order of US$4 billion per annum in the US alone.