UK-based ReNeuron has unveiled evidence which could lead to a breakthrough in stroke treatment after stem cells injected into rats appeared to repair brain damage caused by stroke.

Commenting on the data, Professor Trevor Jones, chairman of ReNeuron said: "These results represent a major breakthrough for ReNeuron and a significant milestone in the wider cell therapy field. We believe that they give ReNeuron a critical competitive and technological edge in the race to realise the huge therapeutic potential of stem cells."

ReNeuron floated on the stock market in 2000 at the height of the biotech boom but suffered a major setback in early 2003 when it admitted its stem cell lines were too unstable to be used in clinical trials.

Private owners bought out the company shortly afterwards, and its researchers announced that its immortalised, human, neural stem cell line has been perfected.

The company says its investment in developing what it considers the 'gold standard' for stem cell therapy: stable, non-tumour forming cells with normal, stable genomes has given it significant advantages over competing technologies.

Professor Jones concluded: "It is heartening to see a UK company taking a lead in this incredibly exciting area of medical science, and benefiting from the supportive environment that currently exists in the UK for stem cell research."

The ReN001 stem cell therapy for stroke is now being scaled up ahead of late pre-clinical development and the company aims to have approval to standard testing in humans by the end of 2005.

The Guildford-based researchers have broadened their product pipeline and have launched programmes to develop stem cell therapies for type I diabetes, Parkinson's disease, Huntingdon's disease and diseases of retina.

Michael Hunt, chief operating office and finance director at the company said: "ReNeuron has come a long way in the last year, culminating in the breakthrough efficacy data in stroke that we are announcing today. The company is now poised to take a leading competitive position in the stem cell therapy field."

ReNeuron is now looking for £10-15 million from private investors to finance its R&D programmes over the next two to three years, which could bring its lead therapy into phase II clinical studies.

The company has also presented data showing its lead ReNcell lines show the electrophysiological and other properties necessary for their use in non-therapeutic applications such as drug discovery, with a number of industry and academic bodies expressing an interest in the technology.

A second generation ReNcell hepatocyte (liver) cell line is under development for toxicology screening applications.

The use of embryonic stem cells taken from aborted foetuses remains a controversial area, particularly in the US, where President Bush's limiting of its use has been attacked by challenger John Kerry.

Despite the lack of government support, US researchers are still seen as leaders in cellular therapy - in July this year a team at Stanford University announced the success of a similar pre-clinical trial to that conducted by ReNeuron.

pharmafocus@wiley.co.uk