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. |