Dreams,
Goals Filling Bucket Lists Nationwide
Health Insurance Options for Pre-Medicare Spouses
Reduce Risk of Falling by Maintaining Health
Ken's Corner: Getting From A to B: Adventures in Jaywalking
Lilly Alzheimer’s Drug Shows Some Promise in Study
By Tom Murphy
INDIANAPOLIS
(AP) — A possible Alzheimer’s disease treatment from
drugmaker Eli Lilly showed some promise in late-stage research, even
though the drug failed to slow a form of mental decline in two separate
studies of patients with the mind-robbing condition.
Shares of the Lilly climbed recently in morning trading after the Indianapolis
company announced what could be a step toward a long-awaited breakthrough in
the fight against a disease that has no cure and ultimately proves fatal. But
Lilly officials cautioned that it’s important not to overreact to their
initial results.
Lilly said its treatment, solanezumab, failed to slow cognitive decline, which
involves a person’s memory, in two late-stage studies of about 1,000 patients
each. But when data from the trials were combined, scientists saw a statistically
significant slowing of the rate of cognitive decline in the bigger population.
They also saw a statistically significant result when they examined a subgroup
of patients with mild cases of Alzheimer’s disease. The studies focused
on patients with mild to moderate Alzheimer’s cases.
The studies fell short of their main goals, and that means the drug “isn’t
going to the (Food and Drug Administration) tomorrow to be approved for sale,” said
William H Thies, chief medical and scientific officer for the Alzheimer’s
Association, which was not involved in Lilly’s research. Still, he said
the statistical significance of the combined results is important.
“If that can be replicated, that is a major finding,” he said. “It’s
the first time we’ve been able to change the course of Alzheimer’s
disease or any part of Alzheimer’s disease in people.”
Lilly said it will discuss the results with regulators and plan the next steps.
Full results from the studies will be presented at two scientific conferences
in October.
If you look through “rose-colored glasses” at the results, there
may be a sign of potential benefit on cognitive tests, but it is not clear whether
that is enough to make a real difference clinically in how patients do, said
Dr. Ronald Petersen, director of the Mayo Clinic’s Alzheimer’s Disease
Research Center.
The key will be details the company will present later on brain imaging and other
tests, he said. If those show that the drug is helping clear plaque, “it
might mean that the drug is doing what it’s supposed to be doing, but we’re
just attacking the disease too late,” said Petersen, who heads a safety
monitoring panel for two companies working on a different Alzheimer’s treatment.
It’s up to the FDA to decide how much faith to put in secondary analyses
or results in subgroups, he added.
“The danger would be an over-interpretation of a small finding or a subtle
effect,” Petersen said.
About 35 million people worldwide have dementia, a term for brain disorders that
affect memory, judgment and other mental functions. Alzheimer’s is the
most common type. In the United States, more than 5 million people have Alzheimer’s,
which is the country’s sixth-leading cause of death.
Many Alzheimer’s patients typically live four to eight years after diagnosis,
as the disease gradually erodes their memory and ability to think or perform
simple tasks. Current Alzheimer’s treatments only temporarily ease symptoms
such as memory loss, confusion and agitation. They don’t slow, stop or
reverse mental decline.
Drugmakers have tried and failed for years to develop successful treatments for
the disease, and patients and doctors are anxious for any signs of promise. Analysts
have said an approved treatment that slows the disease’s progression could
be worth billions of dollars in sales.
Last month, Pfizer Inc. and Johnson & Johnson said they would end development
of an intravenous version of their potential Alzheimer’s treatment, bapineuzumab,
after two late-stage studies showed it worked no better than a placebo in patients
with mild-to-moderate cases.
Lilly officials cautioned Friday that their study did not show that solanezumab
slowed the progression of Alzheimer’s. It showed signs of slowing cognitive
decline, one of many ways the disease impacts a person’s mind. Even so,
they were encouraged.
Solanezumab binds to beta-amyloid protein, which scientists believe is a key
component to sticky plaque that basically gums up the brain of a patient with
Alzheimer’s disease. The drug is designed to bind to the protein and help
the body remove it from the brain before it can form that plaque. Lilly said
that while the individual trials missed their main goals, the combined results
showed there may be some validity to this approach.
But Dr. Sam Gandy, head of Alzheimer’s disease research at Mount Sinai
School of Medicine in New York, said Lilly’s statement on the results “is
very tentative.”
Baxter International Inc. also reported some encouraging results in July from
its potential Alzheimer’s treatment, Gammagard. The company said a tiny
study indicated Gammagard might help stabilize Alzheimer’s for up to three
years. Four patients who got the highest dose of Gammagard for three years showed
no decline on memory and cognition tests, but a dozen others on different doses
or shorter treatment times didn’t fare as well.
That study was too small to prove the treatment works, but a more rigorous one
involving 400 patients will end late this year, with results expected by early
next year.
This page and its contents ©2012
Metropolitan News Company, Inc.
