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NAPC News 10 August 2012

Teva

Teva Pharmaceuticals is the target of a federal bribery investigation into its business in Latin America.

The company said the US Securities and Exchange Commission was looking into its compliance with the Foreign Corrupt Practices Act, a law that makes it illegal for people or companies to make payments to officials of foreign governments to get or keep business.

Alzheimer’s Disease Drug Shelved After Trial Failure

Two US drug companies have said they will stop the development of an Alzheimer’s drug because it failed in two late stage clinical trials.

Bapineuzumab, made by Pfizer and Johnson & Johnson, was designed to halt build-up of plaque in the brain.  But it failed to improve cognitive or functional performance, compared with a placebo in certain patients.

Alzheimer’s is the most common form of dementia, as well as the sixth leading cause of death in the United States.  An estimated 36 million people worldwide are believed to have dementia, including Alzheimer’s disease.

Both firms announced on 23 July that the first clinical trial of the intravenous (IV) version of bapineuzumab had failed.  In that study, patients with a gene that is associated with a greater risk of Alzheimer’s disease were tested.  But the results with the group were largely the same as with those who did not have the gene, who were tested in the second study.

The second trial’s end means that additional studies on the IV version will not now take place; however, Johnson & Johnson said a study of subcutaneous use would continue.
Some had predicted that the IV studies of bapineuzumab would fail because they were treating those whose brains were already damaged.

‘One of the strong thoughts in the field is that you really have to treat people before they become demented,’ William Thies, chief scientific officer of the Alzheimer’s Association told Reuters, adding that the announcement did not prevent the drug from being tested as a preventative form of treatment.  

Mr Thies said that despite the trial’s failure, data from the experiment could still be useful.  ‘These studies are terribly important for us to learn about Alzheimer’s disease, and that part of the process is just starting as data continues to be crunched in a variety of ways.’

Johnson & Johnson had agreed in 2009 to invest up $1.5bn in bapineuzumab.
In a statement, Steven Romano, head of Pfizer’s Medicines Development Group, said they were ‘obviously very disappointed’ with the trial’s outcome.  We are also saddened by the lost opportunity to provide a meaningful advance for patients afflicted with mild to moderate Alzheimer’s disease that their caregivers.’

A similar drug is being developed by Eli Lilly, solanezumab, is also considered a long-shot to succeed, but results of the trials will  not be made available until later this year.

Cancer Stem Cell Discovery Could Signal Paradigm Shift
Researchers have discovered the cells in tumours that seem to be responsible for their regrowth.

Three separate studies on mice appear to have confirmed the view that the growth of tumours is driven by so-called cancer stem cells.

The researchers claim to resolved one of the biggest controversies in cancer research and say their work marks a ‘paradigm shift’ in the field.

The studies have been published in the journals, Nature and Science.
Doctors often successfully reduce the size of tumours through various therapies, but often patients suffer a relapse and the tumour regrows.  Some researchers believe this happens because therapies fail to eradicate a small proportion of cells that drive tumour growth known as cancer stem cells.  They think that these are the cells that should be targeted to eliminate the tumour permanently.

Evidence for the existence of cancer stem cells has been weak.  Now, however, three separate groups of researchers working independently have found direct evidence of cancer stem cells driving tumour growth in brain, gut and skin cancers.  The suggestion is that the same may be true of all cancers, which produce solid tumours.
According to Professor Cedric Blanpain of the Free University of Brussels, who led one of the studies, the results could pave the way for a new approach to treating many cancers.  ‘If these cells are indeed the cells that fuel tumour growth then maybe you can target these cells.’

That may, however, be easier said than done.  The newly identified cancer stem cells are very similar to healthy stem cells responsible for growing and renewing tissue in the body.  Any therapy to target cancer stem cells may also destroy healthy tissues.  A priority for researchers will be to see if there are important differences between normal and cancer stem cells so that therapies can distinguish between them.
According to Professor Hugo Snippert of the University Medical Centre in Utrecht, who led the study into intestinal tumours, the confirmation that these cells exists is an important step in future cancer research.  ‘Many argued that these cells did not exist.  But we have shown for the first time that there is such a thing as a cancer stem cell and that tumours are maintained by them.’

Professor Luis Parada of the University of Texas, who led research that identified stem cells in brain tumours in mice, said he believed there would now be a new approach to developing new treatments for solid tumour cancers.  Cancer stem cells change the paradigm.  The goal of shrinking tumours may well turn out to be less important than targeting the cancer cells in those tumours.

Dr Michaela Frye, a Cancer Research UK scientist, based at the University of Cambridge, said: ‘These results add even more weight to the theory that cancers are driven by a distinct group of cells called cancer stem cells.  Because cancers are proving to be so complex, we don’t yet know how relevant this research into mice is to humans, but it gives us new insights into how cancers might develop, and why they can sometimes grow back after therapy.’

Drug Companies Putting Profit Ahead Of Medical Discoveries

According to a report in the Independent this week, scientists have warned that the pharmaceutical industry has been spending the last decade developing new drugs, which have produced little benefit and caused considerable harm in order to maximise profits.
Independent reviews suggest that 85 to 90 per cent of new drugs provide little benefit over existing treatments with some, such as Merck’s painkiller, Vioxx and GlaxoSmithKline’s diabetes drug, Avandia, causing serious side effects, which led to their withdrawal.

Liquid To Wipe Out Superbug

Researchers have created a disinfectant that could save thousands of lives by killing hospital superbugs in seconds.

The liquid called, Akwaton, kills C.diffficile and MRSA bacteria, which are responsible for 5,000 patient deaths a year.

Researcher, Dr Mathia Oule from Winnipeg, Canada, said: ‘It’s an ideal disinfectant for hospitals and laboratories.’

The UK Society of Microbiology hailed it as a major clinical advance.    
Drug Setback Leaves Astra And BTG In Poor Health
AstraZeneca and BTG have axed plans to develop a new drug to treat severe blood poisoning after it failed medical trials, sending both companies’ shares plunging.
Stage II trails comparing doses of the duo’s CytoFab treatment with placebo drugs in patients with severe septicaemia or septic shock ‘did not show any significant improvements versus the placebo’, the firms said.

BCG Injection Could Offer Fresh Hope For Diabetics

The generic BCG vaccine given to thousands of British children has the potential to become a treatment for type 1 diabetes.

The vaccine briefly allowed three patients to begin producing insulin again after more than a decade with the condition, which was previously thought to be irreversible, a preliminary study found.  ‘These are not people throwing their syringes away – the increase is tiny- but it’s proof of the concept that we can kill the bad T-cells in a targeted way’, said Denise Faustman, of Harvard Medical School, who led the research.  ‘If we can take people 15 to 20 years out and stabilise them, it could have substantial long-term effects.’