At the request of the U.S. Food and Drug Administration, Pfizer Inc. has halted mid-stage clinical studies of what would have been the world’s first biologic pain reliever for back and diabetes-related discomfort.

The news about the once-heralded drug tanezumab, released Monday shortly after the stock market closed, is yet another blow for Pfizer’s new-drug pipeline as the company faces the November 2011 expiration of the patent on Lipitor, the world’s leading medicine, with sales of more than $11 billion last year. It also is disappointing news to Pfizer’s drug-development team in New London, which has been involved in setting up and analyzing tanezumab’s clinical studies.

Just last month, Pfizer had presented positive data on tanezumab, demonstrating the injectable antibody’s effect on reducing knee pain in osteoarthritis patients. A week later, New York-based Pfizer, which has its biggest worldwide research site in Groton, announced that the FDA had asked it to stop a late-stage study of tanezumab in osteoarthritis patients because some people using the experimental drug wound up needing joint replacements.

The FDA’s latest request “follows further consideration of reports of adverse events in osteoarthritis patients,” Pfizer said in a statement, citing “the agency’s concerns regarding the potential for such events in other patient populations in which the compound is being studied.”

Pfizer said it continues to study tanezumab as a pain reliever for cancer patients and in other groups with unmet medical needs.

Pfizer’s stock price was down 18 cents, or about 1.2 percent, at the end of trading Monday, finishing at $14.55 a share.

The latest drug-testing closure for Pfizer follows several years of bad luck and bad decisions regarding some of the company’s most-promising medicines.

Among the most spectacular failures have been heart medication torcetrapib, once heralded as a potential successor to Lipitor but, after an $800 million investment in research during clinical trials, found to result in excessive deaths; the inhaled insulin Exubera, which never caught on with patients and cost the company nearly $3 billion, and the Russian-born antihistamine Dimebon, which had shown excellent results in midstage trials on Alzheimer’s disease but utterly failed in clinical tests that ended earlier this year and cost Pfizer at least $300 million.

Tanezumab was one of the most promising drugs being developed by San Francisco-based Rinat Neuroscience Corp. when Pfizer bought the company four years ago for a reported $500 million. A pipeline review announced by Pfizer just last year put tanezumab as among its top drug prospects.

Earlier studies of the drug showed significant pain relief and no major health risks.

“Repeated dosing with this compound gives sustained pain relief,” Northwestern University researcher Thomas Schnitzer told the website MedPage Today last fall.

But naysayers have questioned the potential market for tanezumab, wondering if an injectable biologic pain reliever would be embraced. Biologic medicines are made with live organisms.

Pfizer indicated it has not given up on tanezumab. It said the shutdown of its latest clinical trials would have no effect on the employment of local scientists.

“Pfizer will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab,” the company said.

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Barclays’ Tony Butler told Bloomberg that a drug that demonstrates an ability to reduce memory loss should be able to garner $5 billion in annual sales. But collecting that money is far from a sure thing. “It’s a very risky area,” says Butler.

Lilly’s strategy has been to target the plaque that accumulates in the brains of Alzheimer’s patients, even though scientific opinion isn’t unanimous that beta amyloid is responsible for the disease.

Nevertheless, Lilly’s semagacestat and solanezumab programs target beta amyloid along different pathways, and researchers have been recruiting more than 1,000 patients for each of a series of late-stage trials. “We know our drugs are having an effect in the brain,” says Eric Siemers, Lilly’s medical director on the Alzheimer’s team. “Now, is it enough of an effect? We don’t know.”

Investors have been here before. The need for Alzheimer’s drugs is so high that the bar for an approval is relatively low. But after Dimebon failed a late-stage trial recently, failing to perform any better than a sugar pill, analysts have grown wary about predicting successes or failures.

One area where there has been clear success, though, is in diagnosing the ailment. Avid Radiopharmaceuticals, in particular, has been singled out for its success in developing an effective new diagnostic test for the disease.

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The researchers’ work, done on rodents, builds on findings that all mammals, including humans, make brain cells throughout their lives. Most of these die, but this drug helps more of the baby cells survive and grow to become functioning brain cells.

“We make new neurons every day in our brain,” Andrew Pieper of the University of Texas Southwestern Medical Center in Dallas who worked on the study, said in a telephone interview. “What our compound does is allow more of them to survive.”

The compound is called P7C3 for now, and the researchers have already started tweaking it to make it more effective. They said it seems safe and appears to work even when taken as a pill.

The compound is similar to Medivation and Pfizer experimental Alzheimer’s drug, Dimebon, and may provide ways to improve its effects, Pieper and colleagues reported in the journal Cell.

It is also similar to some compounds owned by Serono, the researchers said.

Dimebon, originally a Russian-made antihistamine also known as latrepirdine, failed in a clinical trial for Alzheimer’s disease in March.

“For the sake of patients suffering from Alzheimer’s disease, it is hoped that the apparently marginal clinical utility of Dimebon might be enhanced by improvements in both its potency and ceiling of proneurogenic, neuroprotective efficacy,” the researchers wrote.

“If so, our work offers concrete assays for the development of improved versions of these neuroprotective drugs.”

Alzheimer’s gradually destroys the brain and affects 26 million people globally. Drugs, such as Pfizer’s Aricept, improve symptoms only minimally.

The researchers went through 1,000 representative compounds from 300,000 chemicals, pooled them, and administered them to mice. They then dissected the brains to see whether any of the mice had made new cells in the hippocampus, a region of the brain associated with learning and memory.

They eventually narrowed the field to P7C3.

When they gave it to old rats for two months, the elderly rodents did far better than other old rats in learning their way around a water maze.

When dissected, the treated rats turned out to have three times the usual number of newborn neurons in a brain region called the dentate gyrus.

They made a derivative of P7C3 called A20 that worked even better

When the researchers tested Dimebon and the Serono compounds, they found these drugs also stimulated the growth of new brain cells. Being able to target their effects could lead to better drugs to treat Alzheimer’s and perhaps other diseases that destroy brain cells like strokes and amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig’s disease.

“This striking demonstration of a treatment that stems age-related cognitive decline in living animals points the way to potential development of the first cures that will address the core illness process in Alzheimer’s disease,” said Dr. Thomas Insel, director of the National Institute on Mental Health, which helped pay for the study.

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through a maze when other rats, who had not received the drug, could not. The researchers hope the drug can be used to increase the effectiveness of Alzheimer’s drugs like Dimebon, which recently failed in clinical trials.

“For the sake of patients suffering from Alzheimer’s disease, it is hoped that the apparently marginal clinical utility of Dimebon might be enhanced by improvements in both its potency and ceiling of proneurogenic, neuroprotective efficacy,” the researchers wrote. “If so, our work offers concrete assays for the development of improved versions of these neuroprotective drugs.”

More than 25 million people currently suffer from Alzheimer’s disease, which is a progressive disease that destroys the brain until autonomic functions cease and the sufferer dies. P7C3 represents a hopeful breakthrough in research that could lend itself to other areas of brain trauma treatment, including helping people with ALS (also known as Lou Gehrig’s disease).

Dr. Thomas Insel, director of the National Institute on Mental Health, said, “This striking demonstration of a treatment that stems age-related cognitive decline in living animals points the way to potential development of the first cures that will address the core illness process in Alzheimer’s disease.” The National Institute on Mental Health helped fund the study.

The rats that were treated with the drug had three times as many developing brain cells. Researchers have since used P7C3 to create a derivative drug called A20 that shows even more promise. When the derivative was combined with Dimebon and Sereno, two test-phase Alzheimer treatments, it caused new brain cell growth stimulation.

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The studies raise the possibility of a cure for memory loss and fading mental faculties in an ageing population, according to experts who stress that a lot more work is needed to develop the early animal research.

Alzeheimer Scotland says about 65,000 people have the condition in Scotland and the number of people affected will pass 100,000 by 2029.

Scientists in the US screened thousands of compounds for their brain-protective properties. They identified one called P7C3 that had dramatic effects on ageing rats and genetically engineered mice.

The molecule spurred on the growth of new neurons in a part of the brain vital to memory, according to the research, which has been reported in the journal Cell.

It significantly improved the ability of ageing rats to swim through a water maze – a standard test of memory-dependent learning – and assisted the birth of brain cells in mice.

Further research showed that a derivative of the compound, called A20, had an even bigger impact on the brain.

The scientists are still trying to find out how the drugs work. They appear to prevent a process called apoptosis, which causes cells to self-destruct.

Thomas Insel, director of the US body that funded the work, the National Institute of Mental Health (NIMH), said: “This striking demonstration of a treatment that stems age-related cognitive decline in living animals points the way to potential development of the first cures that will address the core illness process in Alzheimer’s disease.”

A key factor is that P7C3 can be swallowed, rather than having to be injected.

Dr Steven McKnight, one of the research leaders from the University of Texas Southwestern Medical Centre in ­Dallas, said: “The neuroprotective compound, called P7C3, holds special promise because

of its medication-friendly properties.

“It can be taken orally, crosses the blood-brain barrier with long-lasting effects, and is safely tolerated by mice during many stages of development.”

The “blood-brain barrier” is a biological wall designed to prevent potentially harmful substances entering the brain.

Drugs that target the brain have to overcome this obstacle if they are to be effective.

Scientists now know that the adult brain is “plastic” and capable of regenerating itself under the right conditions.

Nerve growth in the hippocampus, the brain’s memory ­centre, can potentially stave off mental decline.

However, even in a normal brain most of the newborn neurons die during the month or more it takes them to develop and become “wired in”.

Newborn hippocampus neurons are known to fare much worse in people with age-related disorders such as Alzheimer’s, which cause the runaway death of nerve cells.

The scientists set about trying to find compounds that might protect vulnerable growing neurons in the dentate gyrus, a key area of the hippocampus.

They found that giving P7C3 to the genetically engineered adult mice reduced the death of newborn cells.

It prevented the stunted growth of branch-like neuronal extensions, and thickened an abnormally thin layer of cells by 40%.

When the compound was fed to ageing rats, they outperformed other rodents in the water maze test.

This was traced to a level of newborn neurons in the dentate gyrus of the treated animals, which was three times higher than normal.

Other compounds with structural similarities to P7C3 may also be worth investigating, said the scientists.

At least two of these have already been looked at as potential Alzheimer’s treatments. The P7C3 derivative A20 was 300 times more potent than one of these drugs, Dimebon, which failed in a Phase III patient trial, the researchers said.

They wrote: “The speculative idea that these chemicals share a common mode of action will only be rigorously tested upon identification of their molecular target.”

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The drug, discovered by sheer luck according to researchers, stops brain cells from dying, boosting their numbers and sharpening memory.

Given early enough, it could prevent sufferers from reaching the devastating final stages of the disease, in which they lose the ability to walk, talk and even swallow.

Some experts believe it could even be a cure.

Alzheimer’s and other forms of dementia blight the lives of more than 800,000 Britons, and the number of cases is expected to double within a generation.

With the death of brain cells at the core of Alzheimer’s, the breakthrough brings fresh hope.

U.S. researchers found the drug after testing more than 1,000 chemicals on mice. Dr Steven McKnight said: ‘We really didn’t know if the screen would turn up a favourable compound or not. It was blind luck.’ In tests, the drug, known only as P7C3, boosted the production of cells in a part of the brain critical to memory.

Dr McKnight, of the University of Texas Southwestern, said: ‘These mice are bad at making new neurons. The question was, “Can you fix that?” And the answer to that was “yes”.’ Not only did the new brain cells form, but they also worked properly, the journal Cell reports.

In other experiments, the drug improved memory in ageing rats, making it easier for them to find their way through a maze. Further research showed that a derivative of the compound, called A20, had an even bigger impact on the brain.

Dr McKnight and colleague Dr Andrew Pieper are still trying to find out how the drug works.

It appears to prevent a process called apoptosis, which causes cells, including many newly-formed brain cells, to self-destruct.

It also seems to give a boost to the mitochondria, the tiny batteries that power cells.

The research team hope the chemical can be turned into a once-a-day pill. Those with multiple sclerosis, Huntington’s disease and schizophrenia might also benefit. Dr McKnight said: ‘The neuroprotective compound P7C3 holds special promise because of its medicationfriendly properties.

‘It can be taken orally, crosses the blood-brain barrier with long-lasting effects, and is safely tolerated by mice during many stages of development.’

The blood-brain barrier is a biological ‘wall’ designed to prevent potentially harmful substances entering the brain.

Thomas Insel, director of the U.S. body that funded the work, the National

Institute of Mental Health, said: ‘This striking demonstration of a treatment that stems age-related cognitive decline in living animals points the way to potential development of the first cures that will address the core illness process in Alzheimer’s disease.’

But the development of an effective pill does not bring with it a guarantee of treatment on the NHS, with current drugs severely rationed.

One, Aricept, costs just £2.50 a day but is rationed to those with ‘ moderate’ illness.

Rebecca Wood, of the Alzheimer’s Research Trust, said: ‘Any research that moves us towards a way of preserving the life of cells in the brain is worthy of attention. Steps must now be taken to research whether the compound can be used beneficially and safely in people.’

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Dimebon Over Counter Treatment

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The researchers’ work, done on rodents, builds on findings that all mammals, including humans, make brain cells throughout their lives. Most of these die, but this drug helps more of the baby cells survive and grow to become functioning brain cells.

“We make new neurons every day in our brain,” Andrew Pieper of the University of Texas Southwestern Medical Centre in Dallas who worked on the study, said in a telephone interview. “What our compound does in allow more of them to survive.”

The compound is called P7C3 for now, and the researchers have already started tweaking it to make it more effective. They said it seems safe and appears to work even when taken as a pill.

The compound is similar to Medivation Inc (MDVN.O) and Pfizer Inc’s (PFE.N) experimental Alzheimer’s drug, Dimebon, and may provide ways to improve its effects, Pieper and colleagues reported in the journal Cell.

It is also similar to some compounds owned by Serono, the researchers said.

Dimebon, originally a Russian-made antihistamine also known as latrepirdine, failed in a clinical trial for Alzheimer’s disease in March.

“For the sake of patients suffering from Alzheimer’s disease, it is hoped that the apparently marginal clinical utility of Dimebon might be enhanced by improvements in both its potency and ceiling of proneurogenic, neuroprotective efficacy,” the researchers wrote.

“If so, our work offers concrete assays for the development of improved versions of these neuroprotective drugs.”

Alzheimer’s gradually destroys the brain and affects 26 million people globally. Drugs, such as Pfizer’s Aricept, improve symptoms only minimally.

OLD RATS, NEW TRICKS

The researchers went through 1,000 representative compounds from 300,000 chemicals, pooled them and administered them to mice. They then dissected the brains to see whether any of the mice had made new cells in the hippocampus, a region of the brain associated with learning and memory.

They eventually narrowed the field to P7C3.

When they gave it to old rats for two months, the elderly rodents did far better than other old rats in learning their way around a water maze.

When dissected, the treated rats turned out to have three times the usual number of newborn neurons in a brain region called the dentate gyrus.

They made a derivative of P7C3 called A20 that worked even better.

When the researchers tested Dimebon and the Serono compounds, they found these drugs also stimulated the growth of new brain cells. Being able to target their effects could lead to better drugs to treat Alzheimer’s and perhaps other diseases that destroy brain cells like strokes and amyotrophic lateral sclerosis, also know as ALS or Lou Gehrig’s disease.

“This striking demonstration of a treatment that stems age-related cognitive decline in living animals points the way to potential development of the first cures that will address the core illness process in Alzheimer’s disease,” said Dr. Thomas Insel, director of the National Institute on Mental Health, which helped pay for the study.

http://www.dimebonalzheimers.com/

Dimebon Over Counter Treatment

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Gloria Lucio had two pencil-sized holes drilled into her skull in April, part of a procedure to possibly combat her Alzheimer’s disease.

The surgeon may have injected an experimental gene therapy drug deep into her brain. Or, after months of tests, consultations and preparation, the Pasadena woman may not have received any treatment at all.

The willingness to endure such a surgery for a clinical trial with no guarantee of treatment seems extraordinary. But Lucio and her husband, Don Jones, acknowledge a biting reality: Even if she did get the drug, it may not work.

The substance that may have been injected — a virus carrying genes intended to produce a chemical called nerve growth factor — looked promising in a preliminary trial, but so have many other now-failed treatments.

Such are the options for someone with Alzheimer’s disease in 2010.

The Alzheimer’s Assn. recently estimated that cases of the neurological disease, which now affects about 5 million Americans, will more than double in the next 40 years — at enormous personal, social and economic costs.

The report was the latest in a drumbeat of dismal news about Alzheimer’s. In March, a Phase 3 clinical trial of the promising drug Dimebon failed to produce positive results — another highly anticipated experiment gone bust. Medications currently in use can only mitigate early symptoms; none have been found to slow the disease.

“There’s a feeling of desperation, not only among people with Alzheimer’s disease or mild cognitive impairment but also with their family caregivers,” said Gail Hunt, president of the National Alliance for Caregiving.

But behind the gloomy headlines, researchers say they know more about the cunning illness than ever before. They’re developing techniques to identify it in its earliest stages, and within the next decade they expect treatments to slow or forestall the disease.

Given the swelling numbers of those afflicted, any advance can’t come too soon.

“I want to get well,” Lucio said on a rainy morning, a few days before her April surgery. “I want my brain to be healthy. But I’m scared. The holes — how big will they be?”

Her son, Valentin, 18, was sitting nearby. He points to the tip of his pinkie finger. “The holes are this big, Mom.”

She nodded, still worried.

Lucio was reluctant to undergo the experimental treatment but, with a clear understanding of the situation, felt she had no choice. The disease had been making steady advances for years, quietly stealing pieces of her identity.

A former nurse-practitioner and political activist, she was afflicted with Alzheimer’s at an earlier age than most patients. Lucio is homebound now and no longer fixes meals or pays bills. Her short-term memory is a sieve, and her husband and son don’t leave her alone for long.

“How old are you?” she is asked.

“Sixty-eight,” she said, somewhat hesitantly.

She is 57.

“How big are the holes?” she asked again.

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The failure of Pfizer Inc.’s tanezumab in a study of osteoarthritis patients is the latest in a string of disappointments on promising drugs that didn’t work well or showed safety problems after making it through years of expensive testing:

Last week, two small companies partnering with Pfizer to develop multiple pain drugs said those compounds failed in mid-stage studies.

On Friday, Adolor Corporation said two experimental pain treatments for osteoarthritis of the knee, ADL5747 and ADL5859, didn’t work. Adolor and Pfizer are deciding whether to continue testing them for chronic inflammatory pain.

On Monday, Trubion Pharmaceuticals Inc. said Pfizer ended development of one experimental drug for rheumatoid arthritis, PF-05212374, that didn’t work well. The companies plan to keep testing a second such drug.

In a major setback, a potential blockbuster Alzheimer’s disease drug that Pfizer and a partner were developing, Dimebon, in March failed in a late-stage study to keep symptoms from worsening. Two other studies of Dimebon continue – in combination with other Alzheimer’s drugs and in patients with Huntington’s disease – and might salvage the drug.

Sutent, a pill approved for kidney cancer and gastrointestinal cancer, failed this spring in testing against two other types of cancer. In April, Pfizer stopped a late-stage study in liver cancer patients because they were dying faster than the group taking an existing drug. In March, Pfizer said Sutent did not meet goals in two late-stage studies for advanced breast cancer.

In April 2009, Pfizer stopped another late-stage study of Sutent for advanced breast cancer because it didn’t improve survival rates.

In January 2009, Pfizer stopped development of a drug for advanced pancreatic cancer, axitinib, in late-stage testing. It wasn’t improving patients’ survival.

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DRUG companies are notoriously secretive. The clock starts running on a patent when it is filed, so the longer something can be kept under wraps before that happens, the better for the bottom line. You know something is up, then, when a group of these firms announce they are banding together to share the results of abandoned drug trials. And on June 11th several big companies did just that. They publicised the profiles of 4,000 patients from 11 trials so that they could learn from each other’s failures. An act of selflessness, perhaps, but also one of desperation.

Alzheimer’s disease is one of those things that policymakers would rather hide from. It is, perhaps, the classic illness of old age. Physical frailty is expected, and can be coped with. Mental frailty is much scarier for the sufferer and more demanding for those who have to look after him. It is expensive, too. Alzheimer’s is estimated to cost America alone some $170 billion a year. And it is getting commoner as average lifespans increase. The number of people suffering from the disease is expected to triple by 2050. Effective treatments would thus be embraced with enthusiasm by sufferers and society alike. The right Alzheimer’s drug could earn a drugmaker a lot of money. The incentives are there. But the science has still failed to deliver.

At the turn of the century, Alzheimer’s research seemed promising. A flurry of drugs which treated symptoms of the disorder had just hit the market and researchers were setting out confidently on a deeper investigation of its causes. Understanding those, they felt sure, would result in a cure. It still might, but the truth is that the hoped-for understanding has not come. As a consequence, a long list of would-be cures have failed in late-stage clinical trials, at enormous cost to the companies producing them. The latest of these, Dimebon, made by Pfizer, was abandoned as recently as March, after $725m had been spent on research and development.

Beta testing

The problem of what causes Alzheimer’s is profound. The physical manifestations of the disease that Alois Alzheimer noticed in 1906 are sticky plaques of one type of protein, now known as beta-amyloid, and nerve-cell-engulfing tangles of a second type, called tau protein. Since 1991 the smart money has been on the hypothesis that the disease is caused by the plaques, and that the tangles are mere consequence. For the past two decades, therefore, most attention has been given to developing drugs that will remove amyloid plaques from an affected brain. Five drugs that do this are on the market, but they only delay the onset of dementia. Once their effectiveness has run its course, memory loss and cognitive decline progress unimpeded, and sometimes even accelerate.

Partly as a consequence of this, the plaque theory is waning. Most researchers still believe beta-amyloid is the culprit, but the idea that free-floating protein molecules, rather than the proteins in the plaques, are to blame is gaining ground. This idea is supported by a study published in April in the Annals of Neurology, which showed that mice without plaques, but with floating beta-amyloid, were just as weakened by the disease as mice with both. If that is true in people, too, many more drugs now in clinical trials may prove to be ineffective.

Another fundamental problem is that, whatever is causing the damage, treatment is starting too late. By the time someone presents behavioural symptoms, such as forgetfulness, his brain is already in a significant state of disrepair. Even a “cure” is unlikely to restore lost function. A biochemical marker that indicates the progress of the disease would thus help identify those for whom early action would be advisable, and might help to distinguish people with Alzheimer’s from those with the less hostile forms of forgetfulness that tend to come with old age. Such a marker would also benefit the organisers of clinical trials. They would be able to see more easily whether a drug was working.

To this end, the Alzheimer’s Disease Neuroimaging Initiative (ADNI), established by America’s National Institutes of Health (NIH) in 2004, is measuring the levels of certain proteins in the cerebrospinal fluid of people who may have Alzheimer’s or may go on to develop it. Though the project still has a long way to go, it has already helped develop a test to diagnose the early stages of the disease.

ADNI’s anagram DIAN, the Dominantly Inherited Alzheimer Network, based at Washington University in St Louis, is taking another approach to the biomarker question. Its researchers are studying families with a genetic mutation that triggers the early onset of Alzheimer’s. That terrible knowledge means it is possible to predict which members of a family are destined to get the disease, and compare their biochemistry with that of relatives who do not have the mutation.

It is hard pounding, however, and—as the drug companies’ confession suggests—it is the “R” rather than the “D” of research and development that needs to be emphasised at the moment. A bad time, then, to be cutting back on “R”. That tripling of future sufferers is going to be expensive. Yet Alzheimer’s research, on which the NIH spent $643m in 2006, is to receive only $480m in 2011. It has not been singled out for these cuts. They are part of a general belt-tightening at the agency. But in this as in everything, you get what you pay for. And that might, in the future, be an awful lot of witless, wandering elderly.

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