BioWorld International Correspondent

LONDON - Renovo Group plc disclosed positive results in its fifth Phase IIb efficacy trial of Juvista for the prevention and reduction of scarring.

CEO Mark Ferguson said there were "two or three major messages" coming out of the trial of the human recombinant transforming growth factor beta-3. It was the first study to test the fully lyophilized product, manufactured by Lonza Biologics, of Basel, Switzerland, which will be used in Phase III and for the commercial launch. The study also confirmed the dose of 200 nanograms per centimeter would be appropriate for the Phase III trial.

"There was a broad window of response between 50 and 500 nanograms in subjects from 10 to 72 years, a broad age range," Ferguson said.

Shares in the company rose 11 pence to £ 1.91 when the results were announced.

Renovo licensed worldwide rights, excluding Europe, to Shire plc in June, in a deal with a headline value of $825 million. To date the Manchester, UK-based company has received $125 million of that, in the form of a $75 million up-front payment and a $50 million equity investment. Renovo retains responsibility for clinical trials and expects to start Phase III studies in 2008.

The fifth trial was a single-center, randomized, double-blind study in which each subject acted as his or her own control. Different doses of Juvista were applied around the margins of cuts. Scars from wounds treated with Juvista showed improved appearance compared to placebo-treated wounds in the same person.

The scars were evaluated by plastic surgeons from week six to seven months post-treatment, indicating permanent regeneration of normal skin. The response rate at 200 nanograms was 71 percent.