Lilly trial will test drug for Alzheimer's Phase III stage is a promising step for treatment of disease

It's a disease that slowly shuts down the mind, eventually leaving its victims unable to think, remember or take care of themselves.
But now, Alzheimer's disease, which has puzzled medical researchers for more than a century, is attracting a new wave of drug development, including a move announced today by Eli Lilly and Co. that it is launching its first-ever Phase III trial on Alzheimer's patients.

The Indianapolis drug maker plans to enroll 1,500 patients in 22 countries to test an experimental drug to see if it can slow the progression of the disease.

It's the most sweeping step by Lilly to come up with a treatment for Alzheimer's disease, which is the seventh-leading cause of death in the U.S., affecting about 5 million elderly Americans.
The trials, if successful, could help Lilly overcome numerous setbacks to its drug pipeline in recent years. The company hasn't launched a new drug for humans since 2005. Several of its promising late-stage experimental drugs, including those for brain cancer and diabetes-related eye problems, have run into difficulties with regulators or had disappointing clinical results.
Meanwhile several other drug and biotech companies, including Wyeth Pharmaceuticals and Myriad Genetics, are also pushing hard with late-stage clinical trials in experimental drugs for Alzheimer's disease. Other companies are in earlier stages of research.

At stake is treatment of a disease that robs elderly people of their ability to think and costs the U.S. an estimated $150 billion a year, much of it picked up by taxpayers.

There is currently no cure for Alzheimer's disease. The handful of drugs on the market help patients manage the symptoms.
It generally takes 10 years before a patient dies of complications from being bedridden, often pneumonia or infections.

"That 10 years from diagnosis to death is kind of an awful time, really, because patients can't remember things," said Dr. Steven Paul, Lilly's executive vice president for science and technology. "They become increasingly demented. They can become psychotic and paranoid. It's very difficult to treat them in that condition."

For years, the disease had a low profile, because few people lived into their 80s and 90s. A century ago, the average U.S. lifespan was 52 years. But with medical advances, more people are living decades longer -- and becoming Alzheimer's victims.

"Just a generation ago, in medical schools, when the professors talked about Alzheimer's disease, they said: 'It's very rare. You'll probably never see it,' " said Eric Siemers, medical director of Lilly's Alzheimer research.

What many drug makers, including Lilly, are hoping to do is slow the progression of the disease by attacking what many scientists see as the culprit: the buildup of a sticky protein, called amyloid beta, that turns into a plaque on the brain and eventually kills off brain cells. Lilly's drug, called LY450139, is designed to inhibit an enzyme that creates the sticky protein that typically builds up for years before the first symptoms, mild forgetfulness and cognitive impairment, appear.

One small company, Myriad Genetics of Salt Lake City, last week wrapped up its own Phase III clinical trial of more than 2,500 patients of an experimental drug called Flurizan. The drug is being studied to stop progression of Alzheimer's for patients with a mild form of the disease.
"The new hope is to effect the disease at the very basic pathology, so you're actually stopping it, not just managing the symptoms," said Dr. Daniel D. Christensen, professor of psychiatry, neurology and pharmacology at the University of Utah's Neuropsychiatric Institute.

Most of the drug development is geared toward what researchers call the "amyloid hypothesis" -- that finding a way to stop the buildup of plaque could slow down the disease.

"It's taken the last 20 years of steady progress in understanding how this protein is deposited, how it's metabolized, all the enzymes involved," said Dr. Martin Farlow, professor of neurology at the Indiana University School of Medicine. "But we are now at a point that a number of companies have developed drugs that attack different parts of the process. Now there's a very realistic possibility of stopping this disease."

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