Should see a significant rise on Monday on the back of todays Telegraph write up. It seems that a few of the national papers are keeping a close eye on OMH (Osmetech)
http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2006/03/18/ccmed18.xml&menuId=242&sSheet=/money/2006/03/18/ixcoms.html
New ways to cut the error out of drug trials
By Katherine Griffiths (Filed: 18/03/2006)
Better understanding of our DNA and other high-tech advances will make medical research less risky, says Katherine Griffiths
As the families of six men seriously ill from taking an experimental leukaemia drug wait anxiously for news of whether they will recover, a question doctors and the public will ask is if this tragedy could have been prevented.
The answer is, perhaps, yes. It is too early to say for certain, because it is not yet known what caused the terrible reactions in the human volunteers to the drug TGN1412. There could have been problems with the medicine, but equally it could have been someone giving the wrong dose or a toxic substance getting into its production which was to blame.
Some in the pharmaceutical and biotechnology industries say if it is the drug which turns out to have been the problem, such a tragedy might not have to be repeated. This is because tests that show to a far greater extent than ever before what a drug will do to a human before it is injected into the body are now at the cutting edge of research and development.
The wealth of new information about the way the body works from breakthrough discoveries about our DNA is making these new techniques ever more useful.
The new technologies, most of them still only being worked on by a handful of small companies around the world, which sound more like science fiction than reliable scientific tests, are rapidly being built on top of that foundation.
The methodologies range from computer modelling involving highly complex mathematics to testing drugs on hearts taken from people killed in traffic accidents and kept alive in boxes.
Analysts say these techniques are on the brink of explosive growth, with large pharmaceuticals companies waking up to the fact that they can massively speed up the drug development process and also make it much cheaper, because dud medicines can be scrapped at an earlier stage.
The devastating events at Northwick Park Hospital in north London, which have left two men in a coma and four others still seriously ill, will also inevitably act as a catalyst in getting regulators and public opinion to put pressure on drug developers to turn to new and more sophisticated tests.
Most experts in the pharmaceuticals industry believe such developments will not replace the current system, where drugs are tested in laboratories, then on animals and then in three phases of human trials.
But a growing number believe the traditional system could be greatly improved by adding a range of new tests, especially at the stage when a drug has been given to animals but not yet been introduced as a phase 1 trial in people.
Ibraheem Mahmood, a lifesciences analyst at Investec, points to the emerging field of testing unknown drugs on human organs taken from people who have died from other causes as an area of huge future significance.
"In five or 10 years' time the world's pharmaceuticals and biotechnology companies will still be running the same animal and phase 1 trials but they will also have a battery of supporting tests that provide greater insight into the results of these tests. We'll be able to make much better decisions before committing to large and expensive risky trials," Mr Mahmood said.
One developer of this technique, known as "ex vivo", is a small company called Asterand, which is operating in both both Detroit in the United States and Royston, Hertfordshire, a few miles south of Cambridge.
The company takes tissue from a variety of sources, including accident victims, and from people who have donated their organs which turn out not to be good enough, and either supplies them to drugs companies for tests or does the tests itself.
Ronald Openshaw, Asterand's chief financial officer, said TeGenero, the German company which made TGN1412, was not a client, so it was impossible to tell exactly what tests were done on the drug apart from the animal tests required by regulators before the drug was tried out in humans.
But he said: "That whole bitterly disappointing situation raises the issue of if there was anything else that could have been done."
Mr Openshaw argues that Asterand's technology does, at least in some circumstances, catch such situations. He cited the example of a client which had brought a drug to Asterand for testing.
"The drug had been in pre-clinical development and they thought it caused cardiac toxicity.
"We took some heart muscle and put it in an organ bath where it could be kept beating and effectively alive for three days. We tested the drug on it and found it did have side effects," Mr Openshaw said.
Asterand will not reveal the identity of the company because it keeps all of its clients confidential, but it did say it was a large player in the pharmaceuticals sector which, after it received the results of the trial from Asterand, dropped the drug.
Asterand, which has just 100 employees and has been gradually developing its techniques for the past eight years, says it is now being overwhelmed with demand from large drug companies that want to use its techniques.
Another arena where small developmental companies are finding themselves in demand is in an area known as molecular diagnostics. Thanks to the wealth of information now available about the human genome, companies can work out with far greater precision what a drug will do to a particular person based on their genetic make-up.
A company working in this area is the Boston-based Osmetech. Among the products the company has developed is something called an Esensor, a machine which uses DNA technology.
It is also developing something called an Optigene, a piece of equipment slightly bigger than a laptop computer which will help scientists in labs and doctors in hospitals find information such as a person's metabolism. Such relatively simple information can make a lot of difference in deciding on what dose to give a patient and even whether the medicine will work at all.
The reasons why these areas are some of the fastest growing in the drugs industry are not hard to find. Pharmaceutical companies have to pay more than 500m to bring a single drug from its earliest stages through a multiplicity of tests to the market.
Adopting tests that can determine at an early stage whether the treatment will work in humans or not could save millions of pounds. It is possible that it could also save lives.
16 March 2006[News]: Drug trial victim is like Elephant Man, says girlfriend