abdulhakeem
13-12-04, 12:16 PM
December 13, 2004
By Sam Lister, Health Correspondent
A VACCINE against the most serious form of diabetes is to be tested on humans for the first time, raising the prospect that a cure could be widely available in less than a decade.
The Times has learnt that British scientists have gathered 18 patients with type 1 diabetes, which usually appears before the age of 40, to begin the trial in August.
The beginning of human trials marks one of the most significant advances against the disease since the widespread prescription of insulin began in the 1920s. This has been the only way to treat diabetes for the past 80 years.
It also confirms Britain’s position at the forefront of research into both type 1 and type 2 diabetes — where the focus has moved from trying to control the condition to finding a cure.
The Times understands that British scientists are also investigating the use of stem cells, organ transplants, cell regeneration and advanced drug therapies to restore the body’s ability to produce insulin.
There are 300,000 sufferers of type 1 diabetes, which develops when the pancreas stops producing insulin, in Britain. They need daily injections of synthetic insulin and risk blindness, loss of limbs and death. The disease has increased four-fold among the under-5s in the past 20 years. Type 2 usually appears in older people, particularly the overweight, but is also affecting the young with the increase in childhood obesity.
Diabetes is thought to result from a genetic predisposition caused by an unknown environmental factor which brings about an auto-immune response — when the immune system attacks its own tissues.
The new treatment could act both as a vaccine and a cure. Those with a family risk of diabetes could be vaccinated to prevent it developing, while in newly diagnosed diabetics it could halt progess of the disease as it can take five years for insulin production to cease altogether. However long-term sufferers will not benefit.
Development of the human vaccine, at Bristol University and King’s College London, comes after the successful inoculation of mice, which were injected with protein which stopped the body destroying insulin-producing cells. Diabetic animals were protected from the disease for the rest of their lives.
Three years’ work on blood samples has identified the equivalent human protein sequence, which has been shown to trigger the same effect in laboratory tests.
The vaccine, being produced at a cost of £40,000 by Clinalfa, an offshoot of the pharmaceutical giant Merck, contains a molecule identical to part of the insulin-producing islet cells. When added to human blood, it generates protective cells that block the aggressive white blood cells responsible for destroying the islets.
Colin Dayan, a consultant senior lecturer in medicine at the University of Bristol, said that researchers hoped that the vaccine would replicate this when injected into humans.
The first human trials will involve diagnosed diabetics, who will be assessed for reaction to the vaccine, but will not be able to have full inoculation. The Juvenile Diabetes Research Foundation, which is funding the project, is helping to assemble a larger group of patients for further trials.
“If the principal works, we will then want to conduct a further 18-month full clinical trial, and if there have been no adverse events begin work on more complex vaccine sequences,” Dr Dayan said.
“If you can slow the onset of diabetes in newly-diagnosed patients and hold them where they are, it will be a major achievement. But in terms of rolling it out for the whole population it is more like a 10-year plan.”
Bob Goldstein, chief scientific officer for the foundation, said that work on the type 1 vaccine was a “very hot topic”, and was providing useful research for severe forms of type 2 diabetes, where patients who cannot control blood-sugar with diet need injections.
“This is a major potential pathway to a cure,” he said. “It is absolutely practical in animals, and we should be able to do the same in people. If you can stop people getting the disease by identifying those at risk and protecting them, that counts as a cure.” Georgina Slack, head of research at Diabetes UK, said that the work appeared very promising. “A hundred years ago Type 1 diabetes was a death sentence,” she said. “Now we are seeing new approaches which are improving the chances of a cure.”
DOUBLE THREAT
Type 1 Generally affects younger people. Develops when insulin-producing cells in the pancreas are destroyed, possibly by an unusual reaction of the body. Sufferers cannot control blood-sugar levels and need daily insulin injections
Type 2 Usually appears in middle-aged or elderly people, but is affecting the young with the increase in childhood obesity. Caused when the body fails to respond normally to its own insulin or does not produce enough. Over-weight particularly at risk
http://www.timesonline.co.uk/article/0,,2-1401879,00.html
By Sam Lister, Health Correspondent
A VACCINE against the most serious form of diabetes is to be tested on humans for the first time, raising the prospect that a cure could be widely available in less than a decade.
The Times has learnt that British scientists have gathered 18 patients with type 1 diabetes, which usually appears before the age of 40, to begin the trial in August.
The beginning of human trials marks one of the most significant advances against the disease since the widespread prescription of insulin began in the 1920s. This has been the only way to treat diabetes for the past 80 years.
It also confirms Britain’s position at the forefront of research into both type 1 and type 2 diabetes — where the focus has moved from trying to control the condition to finding a cure.
The Times understands that British scientists are also investigating the use of stem cells, organ transplants, cell regeneration and advanced drug therapies to restore the body’s ability to produce insulin.
There are 300,000 sufferers of type 1 diabetes, which develops when the pancreas stops producing insulin, in Britain. They need daily injections of synthetic insulin and risk blindness, loss of limbs and death. The disease has increased four-fold among the under-5s in the past 20 years. Type 2 usually appears in older people, particularly the overweight, but is also affecting the young with the increase in childhood obesity.
Diabetes is thought to result from a genetic predisposition caused by an unknown environmental factor which brings about an auto-immune response — when the immune system attacks its own tissues.
The new treatment could act both as a vaccine and a cure. Those with a family risk of diabetes could be vaccinated to prevent it developing, while in newly diagnosed diabetics it could halt progess of the disease as it can take five years for insulin production to cease altogether. However long-term sufferers will not benefit.
Development of the human vaccine, at Bristol University and King’s College London, comes after the successful inoculation of mice, which were injected with protein which stopped the body destroying insulin-producing cells. Diabetic animals were protected from the disease for the rest of their lives.
Three years’ work on blood samples has identified the equivalent human protein sequence, which has been shown to trigger the same effect in laboratory tests.
The vaccine, being produced at a cost of £40,000 by Clinalfa, an offshoot of the pharmaceutical giant Merck, contains a molecule identical to part of the insulin-producing islet cells. When added to human blood, it generates protective cells that block the aggressive white blood cells responsible for destroying the islets.
Colin Dayan, a consultant senior lecturer in medicine at the University of Bristol, said that researchers hoped that the vaccine would replicate this when injected into humans.
The first human trials will involve diagnosed diabetics, who will be assessed for reaction to the vaccine, but will not be able to have full inoculation. The Juvenile Diabetes Research Foundation, which is funding the project, is helping to assemble a larger group of patients for further trials.
“If the principal works, we will then want to conduct a further 18-month full clinical trial, and if there have been no adverse events begin work on more complex vaccine sequences,” Dr Dayan said.
“If you can slow the onset of diabetes in newly-diagnosed patients and hold them where they are, it will be a major achievement. But in terms of rolling it out for the whole population it is more like a 10-year plan.”
Bob Goldstein, chief scientific officer for the foundation, said that work on the type 1 vaccine was a “very hot topic”, and was providing useful research for severe forms of type 2 diabetes, where patients who cannot control blood-sugar with diet need injections.
“This is a major potential pathway to a cure,” he said. “It is absolutely practical in animals, and we should be able to do the same in people. If you can stop people getting the disease by identifying those at risk and protecting them, that counts as a cure.” Georgina Slack, head of research at Diabetes UK, said that the work appeared very promising. “A hundred years ago Type 1 diabetes was a death sentence,” she said. “Now we are seeing new approaches which are improving the chances of a cure.”
DOUBLE THREAT
Type 1 Generally affects younger people. Develops when insulin-producing cells in the pancreas are destroyed, possibly by an unusual reaction of the body. Sufferers cannot control blood-sugar levels and need daily insulin injections
Type 2 Usually appears in middle-aged or elderly people, but is affecting the young with the increase in childhood obesity. Caused when the body fails to respond normally to its own insulin or does not produce enough. Over-weight particularly at risk
http://www.timesonline.co.uk/article/0,,2-1401879,00.html