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Stroke is the name given to sudden neurological deficits most commonly caused by obstruction of an artery supplying a region of the brain. Any region of the brain can be affected. ReNeuron's cell therapy programme for stroke, ReN001, has the potential to be the first clinical stage neural stem cell treatment for a major neurological disorder.
We intend to take ReN001 forward into Phase I/II clinical trials, initially in patients suffering chronic disability post-stroke. We will generate sufficient data to support an application for fast track status, allowing as early a market launch as possible.
There are an estimated twelve million survivors of stroke in the principal European, American and Japanese markets, with the number of new cases in these markets growing at 7 per cent per annum. Approximately 30 per cent of stroke patients require ongoing nursing care, estimated to cost as much as $45 billion per annum in the US alone.
The 20 per cent of survivors with moderate or severe disability after stroke are potential candidates for stem cell transplantation therapy. Existing drug treatments serving these patients are limited and seek to address the effects rather than the cause of the condition.
We have filed our IND application to commence clinical studies with ReN001 in the US, and we hope to initiate a Phase I study in stroke patients as soon as possible.