NEWS
11/12/2008 Juvista and Zesteem trial results
A briefing for analysts and investors to discuss today's clinical results and Renovo's preliminary results for the year ended 30 September 2008 (see separate announcement also issued today) will be held at 14.00 (GMT) today at the offices of Buchanan Communications, 45 Moorfields, London, EC2Y 9AE.
Simultaneous to the meeting, there will be a live audio web cast of the presentation available via www.renovo.com or www.citycomments.co.uk. In addition, there will be a conference call for audience participation in the presentation Q&A session. Dial-in details are as follows: +44 (0)20 8609 1435. PIN code: 640835#. A replay of the conference call will be available for one month via +44(0)20 8609 0289, conference reference 243564#.
RENOVO GROUP PLC
(Renovo or the Company)
RENOVO ANNOUNCES POSITIVE JUVISTA® PHASE 2 RESULT IN VARICOSE VEIN SURGERY, COMMENCEMENT OF EUROPEAN PHASE 3 TRIAL AND ZESTEEM RESULTS
Renovo Group plc (LSE: RNVO), the biopharmaceutical company developing drugs for the reduction of scarring and acceleration of healing, is today pleased to announce a positive result for its lead drug, Juvistaź, for the reduction of scarring, in a multi-centre European trial in varicose vein surgery. This completes a wide-ranging Phase 2 programme for Juvista where a number of doses and dosing regimens have been evaluated.
Furthermore, and as promised, Renovo announces that it has commenced its first European Phase 3 trial for Juvista in scar revision surgery on schedule. This trial uses a dosing regimen which the Company believes will optimise the chances of success in Phase 3.
Renovo also announces today that the Phase 3 trial for a niche product in its portfolio, Zesteem, for the acceleration of healing of split thickness skin graft donor sites, did not meet its primary endpoint. The development of Zesteem will therefore be discontinued as the Company focuses on its lead product, Juvista, and other drugs in its portfolio.
Juvista Phase 2 Trial in Varicose Vein surgery (RN1001-0042)
- Primary endpoint met with statistical significance for 500ng dosed once (p=0.036)
- 156 patient, multi-centre European trial across 22 sites in four countries
- Data consistent with previous findings from Renovo's wide-ranging Phase 2 programme
This trial was a randomised, double-blind, within-patient, placebo controlled Phase 2 study to investigate the safety and efficacy of four doses of Juvista (5, 50, 200 and 500ng per 100șL per linear cm of wound margin) given once following bilateral varicose vein surgery in 156 patients. The trial was a multi-centre European study that took place across a total of 22 sites in four countries.
At the highest dose (500ng per 100șL per linear cm of wound margin administered once) the trial met its primary endpoint (p=0.036), which was photographic evaluation of the upper groin incision by a lay panel over a time period from week 6 to month 7 post surgery using a visual analogue scale (VAS). Juvista treated scars were scored as numerically better using the VAS scale at all time points compared to placebo. The lower doses of Juvista (5, 50 and 200ng per 100șL per linear cm of wound margin) did not achieve statistical significance.
Juvista and placebo treated scars were also compared to each other by a clinical panel (using photographs) and the clinician (on the patient) as secondary endpoints. The incisions treated with the highest dose of Juvista (500ng per 100șL per linear cm of wound margin) ranked better than the placebo treated scars for both assessments at most time points, although the numbers of patients in the trial were insufficient for statistical significance to be achieved in either case.
The results of this trial are consistent with Renovo's previous findings that, when given once, 500ng per 100șL per linear cm of wound margin is the most efficacious dose for Juvista. Other clinical trials (particularly RN1001-0036 & RN1001-0050) have demonstrated that Juvista's efficacy can be further improved by twice dosing, at the time of surgery and 24 hours later.
The safety and tolerability profile to date, including the latest varicose vein trial to report, continues to support Renovo's plan to progress Juvista into Phase 3 development in the EU.
European Juvista Phase 3 trial commences on schedule
As promised, and in line with market expectations, Renovo's Phase 3 trial for Juvista in scar revision surgery has commenced in the European Union. This trial evaluates two doses of Juvista (200ng and 500ng per 100”l per linear cm of wound margin) given twice (following wound closure and 24 hours later) to a total of 350 patients in approximately 50 centres. Patient screening for this trial began in December 2008. Renovo anticipates reporting data from this trial in H1 2011.
Zesteem Phase 3 Trial (RN1002-0066)
Zesteem is a novel formulation of 17_ estradiol and has been shown to accelerate healing (re-epithelialisation) following surgery or wounding.
A Phase 3 trial took place across 30 European centres with one dose of Zesteem (0.1”g/100”l/cm2) or placebo administered to graft sites of 20 to 200cm2 in 296 patients. The primary endpoint of the study was time to complete wound closure of the skin graft donor site as assessed by the clinician.
Although Zesteem demonstrated modest therapeutic benefit in some patients, the trial did not meet its primary endpoint. The Renovo Board has concluded that the trial results are not sufficiently compelling to justify further development of Zesteem and instead has decided to focus the Company's resources on Juvista and the other products in its portfolio.
Outlook
The Company is well funded with Ł82.6m in cash as at 30 September 2008. This provides Renovo with a firm financial foundation on which to develop its pipeline.
Renovo's main priority is to progress Juvista, its lead product, through the European Phase 3 programme. Renovo will also continue to progress the other products within its pipeline. Juvidex® is in a Phase 2 trial for the acceleration of healing, which will report in the first half of 2009. Additionally Renovo is planning to commence a Phase 2 efficacy trial for Juvidex in the reduction of scarring following injury to digital tendons in 2009.
Commenting on today's clinical results, Professor Mark Ferguson, CEO of Renovo, said:
"I am delighted that Juvista treatment demonstrated statistically significant improvements in scar appearance at the 500ng dose level in this multi-centre European Phase 2 trial in varicose vein surgery."
"This result reinforces previous findings from our extensive Phase 2 programme and increases our confidence in the EU Phase 3 trial for Juvista which has commenced on schedule."
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
+44 (0) 7810 157649 (on the day)
Buchanan Communications
Mary-Jane Johnson/Tim Anderson/Lisa Baderoon
+44 (0) 20 7466 5000
Juvista (INN: Avotermin) Trial RN1001-0042 design overview
This trial was a randomised, double-blind, within-subject, placebo controlled Phase 2 study to investigate the safety and scar improvement efficacy of four doses of Juvista (5, 50, 200 and 500ng per 100șL per linear cm of wound margin) given once at the time of surgery to 156 male and female subjects, aged 21 to 76, following bilateral varicose vein surgery by ligation and stripping. The trial took place across 22 centres in the United Kingdom, Belgium, Latvia and Lithuania.
All scars were photographed under standard conditions at week 6 and months 3, 5, and 7. The primary endpoint of the trial was the appearance of the upper groin incisional scars as assessed by an independent panel of lay people (to simulate customers) using a visual analogue scale (VAS) over a time period from week 6 to 7 months post surgery.
Secondary endpoints included ranking of matched upper groin Juvista and placebo treated scars in order of best appearance by a lay panel (using photographs) and the investigating clinician (on the patient assessment).
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 and enhance wound healing.
Renovo has a portfolio of drugs which exploit different novel mechanisms of action to reduce scarring at multiple body sites and accelerate healing. Juvista, 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 commenced in the EU on schedule in H2 2008.
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. Juvidex is in a Phase 2 trial for the acceleration of healing in the skin, which will report in H1 2009 and is due to commence a Phase 2 trial in the reduction of scarring in tendons in 2009. In addition Renovo has an extensive preclinical pipeline.
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