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Scientists make pioneering drug safety breakthrough

A NEW system for checking potential new drugs do not harm the heart has been pioneered in Scotland and is poised to become an international success story.

Dr Margaret Anne Craig: Said the cutting-edge tests in Glasgow were tackling a global problem. Picture: Colin Templeton
Dr Margaret Anne Craig: Said the cutting-edge tests in Glasgow were tackling a global problem. Picture: Colin Templeton

Scientists at Glasgow University have developed ground- breaking technology that shows if new compounds are likely to upset the way the heart beats.

Now they have presented their invention to the United States Food And Drug Administration - at the FDA's request - and the American officials are now considering recommending their kind of system for screening all new drugs before they are given approval.

Dr Margaret Anne Craig, a cardiac scientist who has become the chief executive officer of Clyde Biosciences, the spin-out company taking forward the technology, said: "It is great to think from our little lab we are now on this international platform and we are contributing to something that is a real global problem.

"It is great for science and for the university."

Dr Craig said current methods of screening drugs for cardiac side-effects tend to use synthetic or animal cells and pharmaceutical companies were only discovering at the late stage of clinical trials that drugs were toxic to the heart.

There have also been a number of cases where the impact of medicines on electrical activity in the heart was only discovered after the treatments were available on the market.

Almost 10 years ago the arthritis drug Vioxx was voluntarily taken off the shelves because of an increased risk of heart attacks and strokes.

Similar concerns have also been raised more recently about prolonged use of painkillers in high doses.

The team at Clyde Biosciences, which includes cardiovascular scientists Professor Godfrey Smith and Dr Francis Burton, have adapted technology they had already developed to aid their own research to create a new system for testing the impact of compounds on cardiac activity.

It uses cells that started life as human skin tissue and were turned into stem cells in a lab and then adapted to act and beat like the heart.

The cells are dyed with the membrane appearing fluorescent under a microscope. Minute changes in this fluorescence occur as electrical activity takes place and these are detected and read using their technology known as CellOPTIQ. New compounds can be added to the cells and the reaction monitored.

Dr Craig said: "We can take a measurement 20,000 times in one second. That is the fastest, being able to sample like that. We pick up more information, more directly than other technology on human relevant cells."

According to Dr Craig, the FDA is looking at revising the cardiac guidelines given to drug com­panies seeking approval for new treatments and, after considering five new approaches, is now looking at two technologies including their system. She said: "It has been a huge learning curve. The majority of the time I enjoy it, but there are times when I am just exhausted."

CellOPTIQ could also be used to test potential treatments for correcting heart rhythm problems to see how well they work, and other projects are in the pipeline.

Clyde Biosciences, which has received support from Scottish Enterprise and the British Heart Foundation, is now looking at how to scale up in the event the FDA recommends their methodology.

Jim Watson, director of innovation and enterprise services for Scottish Enterprise, said: "We have been working with Clyde Biosciences for three years providing an integrated package of account management support including a Smart: Scotland award and help with innovation.

"This is a great example of a company that is successfully exploiting its technology to create real commercial opportunities and we look forward to continuing to work Clyde Biosciences to help realise its ambitious growth plans."

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