A new public-private partnership between the UK Government and three big pharmaceutical companies to fund an initiative to use stem cell to test new drugs was announced last week. Stem Cells for Safer Medicine (SC4SM), a not-for-profit consortium, will initially invest over £1 million in projects testing compounds for liver disease. It is believed that stem cells can be utilised to more effectively test for liver toxicity, which is a major factor in drug failure rates and adverse reactions, by turning embryonic stem cells into liver tissue and then using these cells to potentially detect problems not revealed in animal studies.
GlaxoSmithKline, AstraZeneca and Roche have all contributed £100,000 to help establish the initiative, and the remaining £750,000 will be met by several government departments. Dr Philip Wright, who will act as Chief Executive of SC4SM, explained how the ethical implications of using embryonic stem cells had slowed the development of the project. '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 and next year we will have an independent ethics advisory board to provide further advice'.
Using stem cells to test drugs could reduce the need for animal testing, which can sometimes be inconclusive in determining the safety and efficacy of a compound. Professor Ian Cotgreave, a toxicologist at AstraZeneca and the Sweden-based Karolinska Institute, said that, 'The big problem is that, not knowing any better, we are today putting compounds into the regulatory system that then fall down in the clinic'. AstraZeneca ceased production of their anticoagulant, Exanta, after evidence surfaced from clinical trial data that the drug may cause liver damage. Drug testing in the UK is regulated extensively under an array of international codes, professional guidelines, and the Medicines for Human Use (Clinical Trials) Regulations 2004. A drug must undergo animal testing prior to usage in humans during clinical trials but this safeguard can sometimes fail to detect potential adverse reactions in humans. 'It's a problem area where things can be totally silent pre-clinically in an animal and then, as soon as you go into a patient, you get a reaction', said Professor Cotgreave. If successful, the use of stem cells could potentially reduce the enormous research and development costs in drug production, but it would not detract from current safeguards already in place. 'It will be a complementary tool that sharpens up what is put through the regulatory package', commented Cotgreave.
SC4SM will now embark on a five-year plan to invest around £10 million into using stem cells in drug testing. It is proposed that if turning embryonic stem cells into liver tissue proves successful, then heart cells could be targeted next. The initiative will not, however, develop treatments using stem cells.
Sources and References
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Stem cell bank for drug testing may cut animal experiments
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Glaxo, Astra, Roche back stem cells for drug tests
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Stem cells to test medicines?
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Big pharma enters stem cell domain to address safety, attrition
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