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Biotech / Medical : Indications -- scarring, fibrosis, adhesions, keloids

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From: nigel bates9/28/2006 4:16:40 AM
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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 TG beta 3 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/100mL/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/100mL/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.
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