Oxford BioMedica, the gene therapy company, will on Monday announce what it says are the best results anyone in the world has achieved in animal experiments to repair damaged nerves.

Overview - Gene therapy: A rollercoaster ride of hopes and upsets

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Oxford Bio to reveal results on nerve repair
By Clive Cookson, Science Editor
Published: December 14 2003 21:54 | Last Updated: December 14 2003 21:54

Oxford BioMedica, the gene therapy company, will on Monday announce what it says are the best results anyone in the world has achieved in animal experiments to repair damaged nerves.

The data will put the Oxford-based company in a strong position in the race to produce an effective treatment for spinal injury and restore movement to paralysed limbs.

First animal test results for Innurex, Oxford Bio Medica's nerve regeneration product, will be given to a scientific conference in California by an academic collaborator, Prof Malcolm Maden of King's College London. They show "a high level of nerve regrowth" in injured mice.

Alan Kingsman, the company's chief executive, said: "We are seeing neurites, the initial stage of nerve regrowth, bridging the injury gap, at an efficiency that no one has achieved before."

Nerve repair is an extremely active field of research, with scientists throughout the world testing various biological methods to get neurones to bridge the site of an injury and reconnect nerve fibres, so that function is restored.

Christopher Reeve, the Hollywood actor paralysed after a riding accident in 1995, has catalysed the field with his determination to recover and his support for research that might help him to do so.

However, results have generally been disappointing. Several animal experiments that had given excellent preliminary data were not reproducible.

Much research into nerve repair involves transplanting cells - neurones or their precursors - from elsewhere to the site of injury. Oxford BioMedica and King's have a different approach - gene therapy. Innurex uses a virus to carry a gene called RARbeta2 to nerve cells at the injury site; this induces them to sprout new nerve connections.

But the new animal data have not yet been published in a peer-reviewed scientific journal and, in view of past disappointments in spinal injury research, no one will be pinning their hopes on Innurex as an effective treatment until it has been tested more thoroughly.

Oxford BioMedica expects to release more extensive animal data in the spring, showing the extent to which Innurex has restored movement to mice that have been partially paralysed.

If these results are as good as Monday's preliminary data, the company will plan a clinical trial, though this could not take place before 2005.

Innurex is likely to work best when injected by a surgeon directly into the site of a fresh spinal injury, so that nerve growth can be stimulated before scarring sets in. Restoring movement to people such as Mr Reeve, who have been paralysedfor years, is a greater challenge.

The annual potential market for a treatment could be $500m-$2bn (Ł287m-Ł1.1bn).

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Dr. Young eszrevetele:
This is a very interesting approach. The retinoic acid receptor does a lot of interesting things. This particular study used a lentivirus to insert the gene for retinoic acid receptors (RAR-beta 2) into cells and this apparently is causing either the neurons to regenerate or cells around the neurons to pump out factors that are stimulating regeneration. It is hard to judge from these breathless press releases how good the evidence is and what the degree of regeneration is, what has regenerated, and whether there is functional recovery associated with the treatment. This apparently was done in mice but they do not talk about the model or whether there is recovery associated with the regeneration. This still has to undergo peer-review. So, it is of great interest but it is not yet time to be very excited. Incidentally, it may not be easy to get this particular gene therapy approach approved by the FDA. It is using a lentivirus and so there has to be appropriate safety studies, evidence that this does not cause tumors, etc. But, I think that this is good and I shall post whatever I can find about this study in the near future