Interesting comments re. the FDA, wonder if the new political climate will help "oil the wheels" for stem cells. Bush was certainly the sand in the cogs.
Neil.
http://www.ft.com/cms/s/0/df4d60c0-e...0779fd2ac.html
ReNeuron wins UK approval for stem cells trial
A dozen stroke patients in Scotland will be the first in the world to be treated with stem cells.
ReNeuron said UK regulators approved a clinical trial of its stroke treatment, which had failed to win approval from the US Food and Drug Administration.
Following the positive verdict of the UK Medicines and Healthcare Products Regulatory Agency (MHRA), shares in the Guildford-based biotechnology company rose by 174 per cent to close at 7.88p.
Keith Muir, a neurologist at Glasgow University, will lead the trial at the city's Southern General Hospital. He expects to start this summer injecting ReNeuron's "neural stem cells" into the brains of patients who have been left disabled by a stroke.
Animal tests suggest that the stem cells - derived from a cell line that originated several years ago from an aborted human foetus - will help the patient's brain to regenerate, reversing some of the damage caused by the stroke.
John Sinden, ReNeuron chief scientist, said the company had sounded out the MHRA and other European regulators in 2005 about a clinical trial of its stroke therapy and had received an unenthusiastic response. So it went to the US instead.
But ReNeuron's initial optimism evaporated as the FDA consistently refused to approve the trial. "We felt that we could never satisfy them," Dr Sinden said.
When the company returned to the MHRA last year, its attitude was different. "We had a very positive reception," he said.
He added that if those attitudes continued "the UK rather than the US could become the place to carry out stem cell trials of a more difficult nature". But the FDA's stance could change with today's presidential inauguration of Barack Obama, who is more supportive of stem cell research than George W. Bush.
A number of drug companies have accused the FDA of being too risk averse, avoiding the authorisation of new tests and medicines. Its European counterpart has approved a number of trials and drugs more rapidly, including a new procedure allowing biological generic medicines for the first time.
Since 2006, when life-threatening side-effects emerged during tests on six volunteers at Northwick Park Hospital in London, European regulators, including the UK's MHRA, have established a series of special advisory groups to scrutinise high risk trials, including those involving stem cells. They have been keen to ensure appropriate safeguards while maintaining clinical research.
Regulatory delays have left ReNeuron with serious funding problems. But Sir Chris Evans, the biotech entrepreneur whose Excalibur investment group owns almost 30 per cent of ReNeuron, told the FT yesterday: "We have put a funding line in place that will take the company through at least to next year."
Sir Chris said the plan was to raise a substantial amount of money later in 2009 that would fund more extended clinical trials.