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Biotech / Medical : Renovo Plc. -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (32)	9/12/2007 11:17:19 AM
From: keokalani'nui	Read Replies (1) \| Respond to of 40

STATISTICALLY SIGNIFICANT EFFICACY OF JUVISTA® DEMONSTRATED IN PHASE 2 TRIAL USING DRUG SUBSTANCE MANUFACTURED BY LONZA BIOLOGICS 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 2 clinical trial results for its lead drug, Juvista (human recombinant TGFß3), for the first time using Lonza manufactured drug substance. Renovo licensed the worldwide development and commercialisation rights for Juvista, to global specialty biopharmaceutical company, Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) in June 2007, with the exception of the European Union where Renovo retained all rights. Phase 2 Clinical Trial 0050 Highlights • Trial meets its primary endpoint and is highly statistically significant (p<0.0001) • Demonstrates clinical efficacy of Lonza manufactured, microbially derived, drug substance, proposed to be used in Phase 3 trials and commercial supply • Supports 200ng/100ul/linear cm of wound margin as an appropriate dose for Phase 3 studies and establishes a broad response range (50-500ng) • Fifth statistically significant Phase 2 efficacy trial reported for Juvista This trial was a single-centre, randomised, double-blind, placebo controlled Phase 2 study designed to investigate the impact of varying doses of Juvista given once at the time of surgery. Healthy male and female volunteers (aged 18-72) were given Juvista doses of 5, 50, 200 and 500 ng per 100ul per linear cm of incision, as well as placebo. The trial used for the first time drug substance manufactured by Lonza in the lyophilised formulation intended for Phase 3 and commercial supply. This study confirmed previous trials and showed that scars resulting from wounds treated with Juvista show improved appearance compared to placebo treated wounds on the same subject. These results are based upon an evaluation of scars over a time period beginning at week 6 until 7 months post surgery, indicating a permanent regeneration of more normal skin. This is the fifth statistically significant Phase 2 efficacy trial reported for Juvista. It was the first time that 500ng given once had been assessed for efficacy. The 50ng and 500ng doses were both statistically significant (p=0.0018 & p=0.0009 respectively), demonstrating a broad dose response window. In line with previous studies, 200ng produced the greatest magnitude of effect (p<0.0001), suggesting that this may be an appropriate dose to select for Phase 3 clinical trials. Following dosing with 200ng the response rate (71%), as assessed from photographs at 7 months by an independent external panel, was similar to that reported previously. Professor Mark Ferguson, Chief Executive Officer, commented: “This fifth statistically significant trial is very important for Renovo because it is the first time that we have tested Juvista manufactured drug substance at Lonza and the lyophilised product intended for Phase 3 and commercial supply. “Pleasingly this trial supports our previous findings that the optimum dose of Juvista is 200ng/100ul/linear cm of wound margin, given once at the time of surgery, with a broad dosage window of 50-500ng/100ul/linear cm. “We look forward to progressing the development of Juvista with our partner, Shire.” 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 overview This trial (Study RN1001-0050) was a randomised, double-blind, placebo controlled Phase 2 study designed to investigate the efficacy of varying doses of Juvista on scar improvement. 39 male and female subjects aged between 18 and 72 years old were enrolled allowing the study of 312 wounds and scars. Four 1 cm surgical incisions were made all the way through the skin by a plastic surgeon at the same time in similar anatomical locations on both the right and left arms of each subject. Incisions were treated with Juvista or placebo so that each subject acted as their own control. Juvista was administered once by intradermal injection along the wound margins at four doses (5, 50, 200 and 500ng/100uL/linear cm wound margin). Placebo was administered to the site matched location on the other arm. In the trial all scars were assessed clinically and photographed under standard conditions at week 6 and months 3, 4, 5, 6 and 7. The appearance of the scars was then measured using a visual analogue scale (VAS) by an independent panel of either plastic surgeons or lay people (to simulate customers). This study confirmed previous trials and showed that scars resulting from wounds treated with Juvista show an improved appearance compared to placebo. Doses in the range of 50-500 ng/100ul/linear cm yielded statistically significant results on the primary endpoint. The results also suggest a dose of 200ng/100ul/linear cm may be an appropriate dose for Phase 3 clinical trials. In this study, tolerability of Juvista was generally good. 14 days after surgery mild to moderate erythema was reported for sites treated with both placebo and Juvista. No subjects reported severe erythema or any erythema-related AEs.