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Wednesday, May 12, 2010

New theory of Alzheimer’s explains drug failures

http://www.reuters.com/article/idUSN129606120100512

* Plaques may be good, not bad, researchers say

  • Free-floating proteins called ‘oligomers’ the real toxin
  • Drugs that target plaques may be doomed to fail
  • Studies raise doubts about bapineuzumab

By: Julie Steenhuysen

CHICAGO, May 12 (Reuters) - Brain plaques, long considered the chief killer of brain cells and the cause of Alzheimer’s disease, may actually play a protective role under a new theory that is changing the way researchers think about the disease.

Instead of sticky plaques, free-floating bits of a toxic protein called amyloid beta may be what’s killing off brain cells in Alzheimer’s patients, U.S. researchers say.

If the theory is right, then drugs that target plaque, including bapineuzumab — being developed by Pfizer (PFE.N), Johnson & Johnson (JNJ.N) and Elan (ELN.I) — may be aiming at the wrong target, they say.

“The plaque is not the main culprit in terms of toxicity,”

said Dr. Scott McGinnis of Harvard Medical School and Brigham and Women’s Hospital in Boston, who treats Alzheimer’s patients and runs clinical trials testing new Alzheimer’s drugs.

For more than two decades, the prevailing plan of attack for researchers and drug companies has been to find a way to remove sticky clumps of a protein called amyloid beta from the brain.

But several recent studies in mice and rats now suggest that floating pieces of amyloid beta called oligomers are the real bad actors in Alzheimer’s disease.

And instead of being the chief toxin, several teams suspect, the plaques may be the body’s way of trapping and neutralizing oligomers.

“If you say Alzheimer’s, everyone immediately thinks that it’s the plaques that actually cause the disease. That couldn’t be further from the truth,”

Andrew Dillin, of the Salk Institute in California and the Howard Hughes Medical Institute, told reporters in London this week at a conference on aging.

“The data actually suggest these plaques are a form of protection that the body tries to put on. So this is a sign that your brain was trying to do something very useful and helpful to you, and the remnant was the formation of amyloid plaques,”

Dillin said.

A GOOD THING?

Adrian Ivinson, who directs the Harvard NeuroDiscovery Center in Boston, a drug discovery center affiliated with Harvard Medical School working on new Alzheimer’s drugs, said scientists are beginning to think plaque is a good thing.

“It actually sequesters all of that amyloid,” he said, adding that oligomers are “the really toxic substance.”

In the latest study, a team led by Dr. Sam Gandy of the Alzheimer’s Disease Research Center at Mount Sinai School of Medicine in New York genetically engineered mice that form only oligomers, but never brain plaques.

They found these mice developed the same level of memory and thinking problems as genetically engineered mice that get both plaques and oligomers.

And when the team added a gene that converted the oligomers to plaques, the mice got no worse.

“That suggests that plaques were not necessary and the addition of plaque did not make the oligomer-induced memory problems any worse,”

said Gandy, whose study appeared last month in the Annals of Neurology.

The findings may help explain the stunning failure of drugs designed to remove plaques from the brain of patients, which do little to improve thinking in Alzheimer’s patients.

Alzheimer’s is the most common form of dementia in which patients progressively lose their ability to think and care for themselves. Current drugs only treat symptoms.

LACK OF EFFECTS

Gandy points to a recent imaging study in Lancet Neurology looking at the drug bapineuzumab — now in late-stage clinical trials.

The team used an imaging agent called Pittsburgh Compound B or PiB that can be used in brain scans to identify amyloid plaques. Using these scans in 28 patients, the team found that bapineuzumab shrank brain plaques by 25 percent, but Gandy said the drug had no effect on patients’ ability to think and reason.

“We don’t know whether bapineuzumab sees oligomers or not,”

Gandy said in a telephone interview.

And because PiB can only see amyloid deposits and not floating clumps of oligomers, there is no way to know whether the drug is having any effect.

Gandy said the Lancet Neurology study may simply mean that patients need to be treated longer to benefit from bapineuzumab. Or, it may mean that the drug — an engineered immune-system molecule called a monoclonal antibody — is targeting the wrong thing.

Bapineuzumab has had mixed results in a mid-stage clinical trial, and some researchers were encouraged by the Lancet Neurology study because it reduced plaque levels in patients. [ID:nLDE61P171]

But Dillin said the drug, like several others aimed at trying to stop plaques from forming, is destined to fail.

“This hypothesis is actually completely wrong, and we need a new way to start looking at this disease. This is actually not a viable therapeutic avenue,”

Dillin said.

Pfizer this month said results of its U.S. phase 3 trials would be released in mid-2012 and the European phase 3 trials would be done in 2014, a bit later than analysts had expected.

Many investors have already written off bapineuzumab, but since Alzheimer’s afflicts 26 million people worldwide, any success could mean billions of dollars in revenue. (Additional reporting by Kate Kelland in London; editing by Mohammad Zargham)

Tuesday, March 30, 2010

Scientists discover moral compass in the brain which can be controlled by magnets

http://www.dailymail … trolled-magnets.html

Scientists have discovered a real-life ‘moral compass’ in the brain that controls how we judge other people’s behaviour.

The region, which lies just behind the right ear, becomes more active when we think about other people’s misdemeanours or good works.

In an extraordinary experiment, researchers were able to use powerful magnets to disrupt this area of the brain and make people temporarily less moral.

The study highlights how our sense of right and wrong isn’t just based on upbringing, religion or philosophy - but by the biology of our brains.

Dr Liane Young, who led the study, said:

‘You think of morality as being a really high-level behaviour. To be able to apply a magnetic field to a specific brain region and change people’s moral judgements is really astonishing.’

The moral compass lies in a part of the brain called the right temporo-parietal junction. It lies near the surface of the brain, just behind the right ear.

The researchers at the Massachusetts Institute of Technology used a non-invasive technique called transcranial magnetic stimulation to disrupt the area of the brain.

The technique generates a magnetic field on a small part of the skull which creates weak electric currents in the brain. These currents interfere with nearby brain cells and prevent them from firing normally.

In the first experiment, 12 volunteers were exposed to the magnetic field for 25 minutes before they were given a series of ‘moral maze’ style scenarios.

For each of the 192 scenarios, they were asked to make a judgement about the character’s actions on a scale of 1 for ‘absolutely forbidden’ to 7 for ‘absolutely permissible’.

In the second experiment, the magnetic field was applied to their heads at the time they were asked to weigh up the behaviour of the characters in the scenario.

In both experiments, the magnetic field made the volunteers less moral.

One scenario described a man who let his girlfriend walk over a bridge he knew was unsafe. The girl survived unharmed.

Under normal conditions, most people rate the man’s behaviour as unacceptable. But after getting the magnetic pulse, the volunteers tended to see nothing wrong with his actions - and judged his behaviour purely on whether his girlfriend survived.

Another scenario described two girls visiting a chemical plant where one girl asks her friend to put sugar in her coffee.

The friend uses powder from a jar marked ‘toxic’ - but as the powder turns out to be sugar, the girls if unharmed.

Volunteers with a disrupted moral compass tended to rate the girl’s behaviour as permissible because her friend was not injured - even though she was aware the powder came from a jar labelled toxic.

Throughout the experiment, irresponsible or deliberate actions that might have resulted in harm were seen as morally acceptable if the story had a ‘happy ending’, they reported in the journal Proceedings of the National Academy of Sciences.

It’s not the first time that scientists have found parts of the brain that specialise in ethics and morality. Last year American scientists claimed to have found a “god spot” - a region of the brain that controls religious belief.

Read more: http://www.dailymail.co.uk/sciencetech/article-1262074/Scientists-discover-moral-compass-brain-controlled-magnets.html#ixzz0jg1ZpHxt

Monday, January 11, 2010

Research and Markets Announces Global Vaccine Market Forecast to 2012

Research and Markets, the world’s largest market research resource, has announced the report.

According to the report, vaccines have a projected CAGR of over 13% during 2009-2012, placing them among the top lucrative segments of the global pharmaceutical industry. With Europe and the US taking and holding onto the lead as the largest vaccine markets, the global vaccine market is expected to exceed $34 billion in revenues by 2012.

Currently, pediatric vaccines hold a great share of the global vaccine market, but adult vaccines are expected to have a heavy influence on market growth. In particular, the current market for cancer vaccines is thought to be one of the most profitable.

For more information, please visit research and markets.

More Clinical Trials use Computer Records

OTTAWA, Dec. 23 (UPI) — Canadian health officials found 41 percent of clinical trials have moved away from managing trial data using only paper records.

Study leader Dr. Khaled El Emam, the Canada research chairman in electronic health information at the Children’s Hospital of Eastern Ontario Research Institute, evaluated the use of technology in Canadian clinical trials.

From 2006-2007 there were approximately 950 clinical trials registered with sites in Canada — about half funded by the pharmaceutical industry. Industry funded trials were more likely to use electronic data capture tools.

There was no difference between pediatric and adult trials in terms of the use of electronic data capture but pediatric trials used more sophisticated electronic data capture systems.

Electronic data capture tools allow researchers to complete a trial in less time and with fewer errors than if they were using the old paper method to capture and process data manually before entering it into a computer, the researchers said.

“The adoption of technology to collect and manage data in clinical trials is increasing, but mostly for industry funded trials,”

El Emam said in a statement.
“Should academic trials continue to move in that direction, they are expected to gain efficiency and quality benefits.”

The findings are published in the Journal of Medical Internet Research.

Reference:*Article taken from United Press International

Efficient, Secure, Dependable: SES Technology Update Keeps TCG Ahead of the Curve

TCG has recently updated its hardware for the Signal Enhancement System (SES). This technological enhancement will allow patient interviews to be recorded and viewed in a more precise, higher quality format and will further improve international clinical trials.

Clinical trials in the Central Nervous System (CNS) have been riddled with human error as long as they have existed. Problems include inconsistent or biased ratings, patients with incorrect diagnoses participating in the study, or even rating of the wrong interview. All of these issues have decreased the signal in CNS clinical trials. SES is a cost effective and easily implemented system that resolves these issues through interview quality control, study assessment standardization, and scale rating integrity at the investigating sites. The innovative system, which has been used in CNS clinical trials for the last three years, not only ensures that interviews are consistently conducted according to protocol, but also facilitates expert and consensus ratings.

Recently, TCG has updated all of its hardware that it distributes to sites by

  • replacing all of its laptops with a newer, faster model
  • adding a 180 degree, higher pixel motion-detecting camera
  • including a high quality USB microphone that can clearly record conversation up to 50 feet away

The changes are not extraordinary compared to the revolution in clinical trial procedure SES itself brought about with its inception, but nonetheless helps keep SES another step ahead of its competition. For more information on SES, please visit http://cognitiongrou … nal-enhancement.html