Stem Cell Database Proposed to Assess Drug Safety
On the 2nd October 2007, a consortium composed of drug firms and scientists announced plans by which a database of stem cells will be constructed. Its purpose will be to assess how safe new medicinal products are, and it has the support of the UK government.
Entitled ‘Stem Cells for Safer Medicine’, the directive will inject funds of over £1 million into projects designed to generate liver tissue from embryonic stem cells. The end product will be used as a prime resource during the early phase of a drug’s development. While this would allow detection of any harmful component within the drug’s constitution, it may also lead to less animals being used in drug trials.
The period in which a new drug is researched, developed and assessed can often exceed ten years. A large number of new products do not complete this three-tiered process, as, somewhere along the line, harmful elements are detected. Of these, those most frequently observed relate to the human liver.
According to Astra Zeneca’s Ian Cotgreave (also a toxicologist at Sweden’s Karolinska Institute): "The liver is a key organ for toxicity because it's the dustbin of the body, it's where all of the compounds we put into our mouths are [processed]".
He added: "In doing that, it is also the place where a lot of this stuff accumulates and starts to cause problems."
In line with present rules, all experimental drug assessments must involve animals before humans enter the equation. However, forecasting a drug’s behaviour in humans based on monkey/rat-assimilated data can prove troublesome. "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," explained Professor Cotgreave.
To take one example, AstraZeneca’s blood-thinning drug Extanta was pulled, even after having been developed over many years. The reason was the concern, among those involved in researching Extanta, regarding its potential to cause liver damage in the patients taking part in its trial. By then, it had already been tested on animals.
Had the newly-proposed database been in existence then, Extanta's potential risks could well have been identified much earlier on.
In its early life, Stem Cells for Safer Medicine will concentrate on embryonic stem cells that are generic in nature and, therefore, associable with the UK’s population in its widest sense. Ultimately, however, this will be expanded to focus on stem cells which vary in their genetic makeup, in order to assess the performance of new drugs in different circumstances.
Among the consortium's participating groups are AstraZeneca, GlaxoSmithKline, the Department for Universities, Innovations and Skills and the Medical Research Council
Source – Pharmaceutical International’s Research and Development Analyst
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