An experimental Novartis drug can clear malaria infection in mice with a single dose and scientists say it shows promise as a possible future treatment for one of the world’s major killer diseases.

In a study published in the journal Science on Thursday, an international team of scientists said the drug, called NITD609, is effective against the two most common parasites responsible for malaria — Plasmodium falciparum and P. vivax — and also against a range of drug-resistant strains.

In experiments on mice with malaria, the scientists found that NITD609 works in a different way from other antimalarial drugs and that one oral dose was enough to clear the disease.

More safety tests are needed before the drug can be given to humans, but the researchers said that if those are positive, clinical trials in humans could begin at the end of this year.

“A single-dose cure would go a long way to addressing the unmet medical need in malaria, and we look forward to seeing how this compound performs in clinical trials,” said Rick Davis, of Britain’s Wellcome Trust, which supported the research.

The World Health Organization (WHO) says there are about 243 million cases of malaria each year, causing an estimated 863,000 deaths, mostly among young children in Africa.

Although malaria is preventable and curable, it is estimated that in Africa a child dies from the disease every 45 seconds.

The best treatments for malaria are artemisinin combination therapy (ACT) drugs made by firms like France’s Sanofi-Aventis, but they can be expensive. Resistance to chloroquine and sulfadoxine-pyrimethamine, the cheapest malaria drugs, is becoming more common.

The experimental drug NITD609 belongs to a new class of drugs called spiroindolenes. It was identified by the Novartis Institute for Tropical Diseases (NITD) working in an international collaboration supported by the Wellcome Trust, the international Medicines for Malaria Venture (MMV), the U.S. National Institutes of Health (NIH) and several other bodies.

Scientists screened 12,000 chemicals using an ultra-high throughput robotic screening technique before they singled out NITD609 as a potential drug candidate.

Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said the experimental compound had several “desirable features,” including that it targets a parasite protein not attacked by any existing malaria drugs.

NITD609 also has properties which could enable it to be manufactured in pill form and in large quantities.

“From the beginning, NITD609 stood out because it looked different, in terms of its structure and chemistry, from all other currently used antimalarials,” said Elizabeth Winzeler, also with the NIH, who worked on the team.

If NITD609 behaves similarly in people to the way it works in mice, she said in a report on the work, it may be possible to develop it into a drug that could be taken just once — far easier than current standard treatments in which malaria drugs are taken between one and four times a day for up to seven days.

British drugmaker GlaxoSmithKline is carrying out late-stage testing in people of an experimental vaccine against malaria and expects to see results by 2011. The firm says that if it proves effective, it will seek regulatory approval for the vaccine, called Mosquirix, by 2012.

Source: Reuters

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The 10-year-old Human Genome Project has only just begun to bring to fruition its promise to transform medicine, its founders said on Thursday.

Francis Collins, who led the U.S. component of the project and is now director of the U.S. National Institutes of Health, said that although it may seem that the revolution promised with the publication of the first draft in 2000 is slow in coming, many early predictions had been prematurely hyped.

Scientists have barely scratched below the surface of the possibilities opened up by having access to the whole human gene map, he said, and when they do, their results will determine the way all people are diagnosed and treated for diseases.

“It’s fair to say that most people have not yet had the experience of having their personal medical care directly affected by the sequencing of the human genome,” Francis told a briefing in London marking the project’s 10-year anniversary.

“So while one might argue that the consequences have not come across in the first 10 years in the most dramatic form that some predictors put forward in the year 2000, I think the predictions … were probably a bit overblown.”

“TRULY TRANSFORMATIVE”

Mike Stratton, another of the project’s founders and now director of Britain’s influential Sanger Institute, pointed to several areas of disease where big medical advances had already come about thanks to the ability to read the map of human life.

Cancer drugs, like so-called BRAF inhibitors for malignant melanoma skin cancers — versions of which are being developed by drugmakers including Switzerland’s Roche and Britain’s GlaxoSmithKline — were examples how quickly gene sequencing had given birth to targeted treatments, he said.

“It has taken (only) eight years for a drug to be developed … then to be put into clinical trials and to be shown to work,” he said. “And it works in a cancer that was otherwise untreatable. That’s an illustration of what is possible.”

The genome founders also noted that scientists had already found more than 800 genetic variants that play a role in risks of common illnesses like heart disease, cancers and diabetes.

“Those are shining new light into the way those diseases come about, with implications for both prevention and (drug) therapies,” said Collins.

The scientists’ comments were echoed in the drug industry, where Glaxo’s chief executive Andrew Witty said that reaping the benefits of genome research was always going to be a long haul.

“The great mistake everybody made was thinking that the decoding of the genome would somehow yield a drug. It’s got nothing to do with yielding a drug — it’s got everything to do with yielding a whole array of components and ways of looking at a problem which, together with other things, will yield drugs. It’s going to take time,” he told reporters earlier this week.

But Collins said he had no doubt the project would live up to its potential:

“When a truly transformative advance occurs in science, inevitably there will be in the short term an overly optimistic set of predictions,” he said. “But in the long term…the consequences will turn out to have been underestimated. I think that will…be true of the Human Genome Project.

“I think we will see in the next 10 or 20 years a virtual revolution in medicine — in prevention, in the choice of the right drug for the right person at the right time, and in the development of entirely new drugs.”

Source: Reuters

Popularity: 2% [?]

Inoculating children against flu protects more people of all ages in the larger community, probably because young people tend to spread viruses through physical play, Canadian researchers said on Tuesday.

Researchers at McMaster University in Hamilton, Ontario found there were 61 percent fewer flu cases in isolated communities where children and adolescents received the seasonal influenza vaccine, compared to communities where children received an unrelated vaccine.

Targeting children with a vaccine could protect the wider population, researcher Mark Loeb and colleagues concluded in their report in the Journal of the American Medical Association.

Influenza struck 2,326 unvaccinated participants in the 46 religious Hutterite communities in western Canada that were chosen for study because they have limited outside contacts.

In communities where roughly four out of five children aged 3 to 15 were vaccinated, 3.1 percent of the people got the flu compared to a 7.6 percent infection rate in communities where no one was vaccinated against flu.

This demonstrated the widely-accepted concept of “herd immunity” — that vaccination programs can still be effective even if not everyone is vaccinated — which could have public health implications, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“Before, the healthy adolescent kids were not among those that were highly recommended to get vaccinated,” said Fauci, whose NIAID is part of the U.S. National Institutes of Health, which helped fund the study.

“Now, this shows that even though they don’t usually get into trouble from the flu, you can get double bang for the buck by protecting not only them but the people they come in contact with.”

For instance, if there was a shortage of flu vaccine, it might be more effective to vaccinate the young, even though the flu presents less of a danger to them, because their rough-and-tumble socializing habits can easily spread viruses.

Last month, vaccine advisers to the U.S. Centers of Disease Control and Prevention recommended everyone over the age of six months should receive seasonal flu vaccines every year.

Seasonal flu is blamed for 36,000 U.S. deaths each year.

Fauci said the same universal vaccination policy might apply against the pandemic H1N1 virus known as swine flu, which the CDC estimated has killed about 12,000 Americans.

“Now that we’re talking about vaccinating everyone, this (idea of selective vaccination of children) becomes a little bit of a moot point,” Fauci added in a telephone interview.

Source: Reuters

Popularity: 2% [?]

A comparative Phase IV study of Merck & Co. and Schering-Plough’s Zetia (ezetimibe) and Abbott’s Niaspan (niacin) was stopped early last month, according to a notice posted on the US National Institutes of Health’s online registry of clinical trials. The posting indicated that an “independent steering committee has stopped the trial based on results of a pre-specified, blinded interim analysis,” and that the decision was not due to safety concerns. Merck’s shares fell as much as 5 percent on the news.

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Abbott is listed as one of the trial’s sponsors and collaborators, though spokespeople for the drugmaker, as well as those for the joint venture between Merck and Schering-Plough, said they did not know why the study ended and were not involved in the decision. The trial’s lead investigator, Allen Taylor, declined to disclose the reason for the termination, adding that more information may be provided at a later date.

The randomised ARBITER 6 – HALTS trial began in November 2006 with a planned enrollment of 400 patients who had atherosclerotic coronary or vascular disease, or who were at high cardiovascular risk due to certain other medical conditions. The study, which was expected to conclude later this year, was designed to compare HDL- and LDL-focused dyslipidaemia treatment strategies on carotid atherosclerosis. The primary endpoint was change in carotid intima-media thickness after 14 months, according to the NIH registry.

Commenting on the development, Wells Fargo Securities analyst Larry Biegelsen speculated that “Niaspan likely performed better than Zetia in the HALTS study,” estimating that positive data could eventually add as much as $400 million in sales for Abbott’s product. In addition, Natixis Bleichroeder’s Jon LeCroy, who said a positive or negative outcome for either drug could lead to a rise or fall in prescriptions of up to 20 percent, remarked: “We are now assuming that this trial significantly favoured Niaspan and, as a result, we are decreasing our sales estimates for both Zetia and [Merck and Schering-Plough's] Vytorin.” Analyst Barbara Ryan of Deutsche Bank stated, however, that the negative impact on Merck’s stock was “extremely premature and probably unwarranted.”

Zetia generated revenue of $2.2 billion last year, while Niaspan garnered $786 million in sales.

Source: FirstWord

Popularity: 10% [?]

Scientists believe they have found a potential way to stop cancers establishing themselves in the brain, and essentially becoming terminal.

A UK team discovered cancer cells hijack the brain’s blood vessels to get all the nourishment they need to seed themselves there.

Key to this is a protein on the surface of cancer cells called integrin which allows them to stick to the vessels.

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Drugs that block integrin may stop cancer spread PLoS ONE journal reports.

A fifth of all cancer patients will eventually have disease that has spread to the brain.

Indeed, brain metastases are the most common malignant tumours of the central nervous system, outnumbering by 10 times those that originate in the brain.

Once a cancer has spread to the brain the outlook is not good – even with maximal treatment the median survival is nine months.

Scientists at Oxford University, with funding from Cancer Research UK, the Medical Research Council and the US National Institutes of Health, wanted to investigate exactly how cancers spread.

New understanding

Previously it had generally been assumed that tumour cells grew on the cells that make up the grey and white matter of the brain – the neurons and glial cells.

But Dr Shawn Carbonell and his team found that the metastatic cancer cells start to grow on the walls of blood vessels in the brain in over 95% of cases, and not on the nerve cells.

They looked at samples of a range of cancer cell types from humans and mice.

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From this they also discovered that the removal of the integrin stopped the cancer cells from attaching to the blood vessels and starting to grow.

Dr Carbonell said although this finding was still a long way from coming up with a new treatment for those with brain metastases, it was exciting.

“We have identified the protein that cancer cells use to anchor themselves to blood vessels in the brain. Now we can try to come up with drugs to target this protein and stop metastatic cancer cells from taking hold in the brain.”

Dr Helen George of Cancer Research UK said the discovery was “an important part of the puzzle” and paved the way for new and much-needed treatments to tackle cancers that have spread to the brain.

Source: BBC NEWS

Popularity: 3% [?]

The New York Times reported that a child psychiatrist and researcher made presentations to Johnson & Johnson executives in the past describing how proposed studies of the company’s drugs in children would produce results beneficial for the drugmaker. The information was revealed in court documents pertaining to litigation by state Medicaid programmes in the US, which allege that the programmes were defrauded by the makers of antipsychotic drugs through improper marketing of these products.

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As part of the multistate litigation, Joseph Biederman, who was director of the Johnson & Johnson Center for Pediatric Psychopathology Research, gave lawyers documents that included presentations he made to Johnson & Johnson summarising the centre’s work. In one presentation, documents for a planned trial in paediatric bipolar disorder, which would compare Risperdal (risperidone) to rival drugs, stated that the trial “will clarify the competitive advantages of risperidone versus other neuroleptics.” Another document referring to “Key Projects for 2005″ mentioned a planned study of Concerta (methylphenidate) in adolescents that “will extend to adolescents positive findings with Concerta in ADHD NOS in adults.”

Commenting on the matter, Josephine Johnston, a research scholar at the Hastings Center bioethics research institute, remarked that the documents “raise questions about how well-designed Dr. Biederman’s trials were in that he promised a result to his funders.” Meanwhile, Biederman’s lawyers are asking the judge in the case to seal his testimony and accompanying documents in the lawsuit, claiming they “could be immensely damaging to him, both personally and professionally.”

In a separate matter, Biederman is under investigation by Harvard University and the US National Institutes of Health for the violation of federal and university research rules, following news last year that he allegedly reported to Harvard officials only around $200 000 of the $1.6 million he earned in consulting fees from drugmakers during the period of 2000 to 2007.

Source: FirstWord

Popularity: 3% [?]

Plenty of vigorous exercise may cut a healthy, older woman’s breast cancer risk by 30 per cent, researchers said on Friday.

A study of more than 30,000 post-menopausal women showed that strenuous activity — ranging from housework such as scrubbing floors to running — protected against breast cancer even among those who do not have a higher risk, the researchers said.

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The effect was clearest among lean women.

“We know that being overweight puts women at increased risk of breast cancer,” said Michael Leitzmann, who led the study while at the National Cancer Institute of the U.S. National Institutes of Health.

“What our study shows is that even among women without this increased risk, if they exercise they can get some benefit.”

Breast cancer is the leading cause of cancer deaths among women worldwide, according to the American Cancer Society. The group estimates about 465,000 women died of breast cancer globally in 2007, and 1.3 million new cases were diagnosed.

A number of studies have shown that regular strenuous exercise can help people avoid heart disease, cancer and a range of other conditions.

Leitzmann and colleagues used questionnaires to determine how often the women exercised vigorously. All were healthy when the study began.

After 11 years the researchers found that overall the volunteers who exercised most were 13 per cent less likely to have developed breast cancer.

The reduced risk was even higher — 30 percent — when the researchers compared only women of normal weight, Leitzmann, now working at Germany’s University Hospital in Regensburg, said in a telephone interview.

“The relationship was much stronger among leaner women,” he added.

Interestingly, non-vigorous activity such as light housework, walking, hiking and easy jogging, did not seem to offer any protection against breast cancer, the team reported in BioMed Central’s Breast Cancer Research journal.

The researchers did not look at why exercise may help but Leitzmann noted other studies have shown that working out reduces estrogen levels —a known risk factor for the disease — and protects the body’s general immune system.

Source: CBCnews.ca

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