[h=1]First drug to help you live longer could go on trial next year[/h]
ANTI-AGEING pills are no longer drugs of the future – the first trial in people could begin as early as next year.
Last month, the scientists behind the trial began talks with the US Food and Drug Administration to hammer out the practicalities. The trial aims to test whether a diabetes drug called metformin also delays death and age-related conditions such as heart disease, cancer and mental decline.
It would be the first time a medicine has been tested specifically for delaying ageing in a human trial. "It's groundbreaking," says Sue Peschin of the US-based non-profit organisation the Alliance for Aging Research. "It's significant that the FDA has opened their doors to researchers about the idea."
For a long time the field of lifespan extension has had a flaky reputation, with most of the ideas mooted being either unappealing or impractical, such as near-starvation diets or somehow lengthening the tips of our chromosomes.
Drug regulators do not even officially recognise ageing as a condition in need of treatment, which could make it hard to get medicines approved. But this isn't an insurmountable problem and repurposing an existing drug could help, because we already have long-term safety data.
Metformin has been used to treat type 2 diabetes for decades. That means the researchers could go straight to large-scale testing in people. New drugs typically have to be tested on animals first and then small groups of people. This one aims to follow 3000 people in their 70s for five years, and positive results should be enough for the FDA to approve it, says lead researcher Nir Barzilai of the Albert Einstein College of Medicine in New York.
The chief hurdle is a lack of funding, to the tune of $50 million. The American Federation for Aging Research is supporting the planning stages, and the team is in talks with several potential backers, including the US National Institutes of Health, so Barzilai is confident. "We have interest from multiple sources, so one way or another this trial is going on," he says. After all, if the drug is approved, there is likely to be huge demand for it.
After meeting with the FDA in June, Barzilai says the regulator had only "minor suggestions" and was supportive in principle. The trial does not actually need FDA permission to go ahead, but talking to the agency now means it can be designed to smooth the path to licensing later on.
To begin the trial, all Barzilai needs is the go-ahead from the various ethics committees involved. He says this should be relatively easy as metformin is seen as such a safe drug.
The compound helps people with diabetes by reducing how much glucose the liver makes. Its most common side effects are nausea and diarrhoea, but these can be lessened by raising the dose slowly and taking it with meals.
Interest in metformin's possible anti-ageing effects arose because diabetics taking the drug have lower rates of cancer and heart disease and, in one study, lived 15 per cent longer than people without diabetes.
The explanation is unclear as the compound has multiple effects on cells but one theory is that it mimics the effects of calorie restriction, which delays ageing in many animals. When food is scarce, cells shift into energy-conserving mode, and this seems to have knock-on effects on lifespan.
The proposed metformin trial is not the only sign of progress in the anti-ageing field. This month a trial in dogs is due to begin of a drug called rapamycin. This is already used in people to suppress the immune system, for example, after an organ transplant, but at lower doses it may also mimic calorie restriction.
http://www.newscientist.com/article...id=SOC%7CNSNS%7C2015-GLOBAL-hoot#.VZ5EgHsw320
- 08 July 2015 by Clare Wilson
ANTI-AGEING pills are no longer drugs of the future – the first trial in people could begin as early as next year.
Last month, the scientists behind the trial began talks with the US Food and Drug Administration to hammer out the practicalities. The trial aims to test whether a diabetes drug called metformin also delays death and age-related conditions such as heart disease, cancer and mental decline.
It would be the first time a medicine has been tested specifically for delaying ageing in a human trial. "It's groundbreaking," says Sue Peschin of the US-based non-profit organisation the Alliance for Aging Research. "It's significant that the FDA has opened their doors to researchers about the idea."
For a long time the field of lifespan extension has had a flaky reputation, with most of the ideas mooted being either unappealing or impractical, such as near-starvation diets or somehow lengthening the tips of our chromosomes.
Drug regulators do not even officially recognise ageing as a condition in need of treatment, which could make it hard to get medicines approved. But this isn't an insurmountable problem and repurposing an existing drug could help, because we already have long-term safety data.
Metformin has been used to treat type 2 diabetes for decades. That means the researchers could go straight to large-scale testing in people. New drugs typically have to be tested on animals first and then small groups of people. This one aims to follow 3000 people in their 70s for five years, and positive results should be enough for the FDA to approve it, says lead researcher Nir Barzilai of the Albert Einstein College of Medicine in New York.
The chief hurdle is a lack of funding, to the tune of $50 million. The American Federation for Aging Research is supporting the planning stages, and the team is in talks with several potential backers, including the US National Institutes of Health, so Barzilai is confident. "We have interest from multiple sources, so one way or another this trial is going on," he says. After all, if the drug is approved, there is likely to be huge demand for it.
After meeting with the FDA in June, Barzilai says the regulator had only "minor suggestions" and was supportive in principle. The trial does not actually need FDA permission to go ahead, but talking to the agency now means it can be designed to smooth the path to licensing later on.
To begin the trial, all Barzilai needs is the go-ahead from the various ethics committees involved. He says this should be relatively easy as metformin is seen as such a safe drug.
The compound helps people with diabetes by reducing how much glucose the liver makes. Its most common side effects are nausea and diarrhoea, but these can be lessened by raising the dose slowly and taking it with meals.
Interest in metformin's possible anti-ageing effects arose because diabetics taking the drug have lower rates of cancer and heart disease and, in one study, lived 15 per cent longer than people without diabetes.
The explanation is unclear as the compound has multiple effects on cells but one theory is that it mimics the effects of calorie restriction, which delays ageing in many animals. When food is scarce, cells shift into energy-conserving mode, and this seems to have knock-on effects on lifespan.
The proposed metformin trial is not the only sign of progress in the anti-ageing field. This month a trial in dogs is due to begin of a drug called rapamycin. This is already used in people to suppress the immune system, for example, after an organ transplant, but at lower doses it may also mimic calorie restriction.
http://www.newscientist.com/article...id=SOC%7CNSNS%7C2015-GLOBAL-hoot#.VZ5EgHsw320
