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The pharmaceutical industry on Tuesday announced its first direct involvement in research using human embryonic stem cells.

Three companies have set up a consortium with the government to develop stem cells for safety testing of new drugs through a public-private partnership. The launch of Stem Cells for Safer Medicines, or SC4SM, is significant because “big pharma” has been reluctant to engage in embryonic stem cell research.

Companies fear the reaction in markets such as the US, where the use of human embryos is controversial, and they have left the field to universities and biotechnology businesses.

GlaxoSmithKline, AstraZeneca and Roche are inaugurating SC4SM in collaboration with several government departments.

More companies are expected to join, according to Philip Wright, science director at the Association of the British Pharmaceutical Industry, who will also serve as chief executive of SC4SM.

SC4SM is the international industry’s first public-private partnership on human embryonic stem cells, following a recommendation by Sir John Pattison’s 2005 report on the future of stem cell research in Britain.

Dr Wright said: “It has taken a long time to set up because of the sensitivities. We have an ethical framework that says we should only use existing embryonic stem cell lines [in the UK stem cell bank] and next year we will have an independent ethics advisory board to provide further advice.”

The £1m first phase of a five-year, £10m programme will focus on producing liver cells. Ian Cotgreave, head of molecular toxicity for AstraZeneca, said: “The liver is a key organ for toxicity. It is the dustbin of the body, which neutralises and destroys drugs and toxins.”

Unexpected liver toxicity is the biggest single reason why medicines fail during trials. AstraZeneca’s Exanta, a blood-thinning drug, was a recent casualty.

Animal tests had given no clue to this problem, said Prof Cotgreave. “The predictability for liver toxicity from pre-clinical regulatory testing is almost as good as tossing a coin.”

SC4SM plans to fund five projects over the next year, aimed at converting human embryonic stem cells into hepatocytes (liver cells). These should be a more reliable guide to a new drug’s effect on the human liver.

Two biotech companies with research labs in Dundee – CXR Biosciences and Cellartis – are working on hepatocytes for toxicity and are likely to be involved.

The consortium’s long term strategy will include the conversion of stem cells into other cell types. The second target will be cardiomyocytes (heart cells).

SC4SM will not investigate the therapeutic use of stem cells directly to treat disease, though it will collaborate with researchers who are doing so.

Source: The Financial Times Copyright The Financial Times Limited 2007

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