Juvista Phase II Results

RENOVO ANNOUNCES HIGHLY POSITIVE
PHASE II TRIAL RESULTS FOR JUVISTA

Renovo Group plc (LSE: RNVO), the biopharmaceutical company developing drugs for the prevention and reduction of scarring at multiple body sites, today announces highly positive Phase II confirmatory clinical trial results for its lead drug, Juvista.

Juvista is a therapeutic application of human recombinant TGFβ3 and when injected at the time of surgery has been shown in this and previous trials to markedly improve subsequent scar appearance in the skin.

Phase II Clinical Trial Highlights

• Trial meets its primary endpoint and is highly statistically significant (p<0.0001)
• Statistical significance in multiple secondary endpoints
• Scars treated with Juvista show a markedly improved appearance compared to placebo and standard care
• 12 month study indicates a permanent improvement of scar appearance
• Effective given as a once or twice injection
• Continued excellent safety and tolerability profile

This trial was a fully randomised, double-blind, placebo controlled Phase II study designed to investigate the impact of varying Juvista administration frequency and dose on scar improvement. The primary endpoint was scar appearance 12 months after surgery.

This study confirmed previous studies and showed that scars treated with Juvista show a markedly improved appearance compared to placebo and standard care; this was first evident at months 4-7 and was maintained or further improved at 12 months, indicating a permanent regeneration of more normal skin.

The 200ng/100uL/linear cm dose results were particularly striking with highly statistically significant p-values (p<0.0001).

In addition to meeting the primary endpoint statistical significance was seen in multiple secondary endpoints including the assessment of each person’s scars by a plastic surgeon.

The trial demonstrated that Juvista is effective when administered once, at the time of surgery, or twice, at the time of surgery and the next day. The trial also supports Juvista’s excellent safety and tolerability profile.

Professor Mark Ferguson, Chief Executive Officer, commented:

“At our flotation in April we said that we would report a number of clinical trial results before the end of 2006. These results are the first in what will be a period of significant news flow for Renovo, fulfilling this promise.

“This is the third statistically and clinically significant Phase II efficacy trial for Juvista. In particular I would like to highlight the results for the 200ng/100uL/linear cm dose, which are extremely strong. These demonstrate a very high statistical significance, with p-values around 0.0001.

“Importantly, this trial also establishes the long-term benefit of Juvista, indicating a permanent regeneration of more normal skin which is consistent with the drug’s mechanism of action – which we discovered.

“Juvista has now been administered to over 1,000 people and has an excellent safety and tolerability profile.”

Pipeline update

Renovo will provide an update on its pipeline for investors and analysts at 10.00am on Tuesday 24 October 2006. The meeting will be held at the offices of Buchanan Communications, 45 Moorfields, London, EC2Y 9AE.

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. The web cast will also be available for replay shortly after the presentation.

For further information:

Renovo
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 background

This trial (Study RN1001-1011) was a fully randomised, double-blind, placebo controlled Phase II study designed to investigate the impact of varying Juvista administration frequency, drug volume injected and dose on scar improvement. 67 healthy male Caucasian subjects aged between 18 and 45 years old were enrolled allowing the study of 402 wounds and scars.

Six 1 cm cuts all the way through the skin were made by a plastic surgeon at the same time in similar anatomical locations on the right and left arms of each person. Incisions were treated with Juvista, placebo or standard care so that each person acted as their own control. Juvista was administered by intradermal injection at the wound site either once (immediately prior to incision) or twice (immediately prior to incision and 24 hours later) and at varying volumes of a given dose (50ng/100uL/linear cm wound margin and 200ng/100uL/linear cm wound margin).

In the trial, all scars were assessed clinically and photographed under standard conditions every month for 12 months. The appearance of the scars was then rated by both plastic surgeons, examining the person, and a panel of lay people (to simulate customers), examining the standard photographs.

The 200ng/100uL/linear cm dose results were particularly striking with highly statistically significant p-values (p<0.0001).

In addition to meeting the primary endpoint statistical significance was seen in multiple secondary endpoints including the assessment of each person’s scars by a plastic surgeon.

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 big Pharma 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.