* Groups say new guidelines may make drug trials easier
* Findings may improve odds for J&J/Pfizer drug
By Julie Steenhuysen
CHICAGO, July 12 Academic and industry experts
said on Tuesday they have convinced U.S. regulators to ease
safety restrictions imposed on clinical trials of Alzheimer's
drugs, a move that could improve the chances that a drug being
developed jointly by Pfizer (PFE.N) and Johnson & Johnson
(JNJ.N) might succeed.
A 2008 study of 240 patients testing that drug, known as
bapineuzumab, found a dozen cases of a brain swelling condition
called vasogenic edema, shaking confidence in the safety of
agents that reduce levels of a protein called beta amyloid that
accumulates in the brains of Alzheimer's patients.
That study prompted the U.S. Food and Drug Administration
to issue stricter safety guidelines for clinical trials of
drugs that alter amyloid in the brain, Maria Carrillo of the
Alzheimer's Association said in a telephone interview.
The guidelines restricted patients in the trials to having
no more than two incidents of cerebral microhemmorhages, or
tiny leaks of blood in the brain, before they enter a study.
They also called for frequent MRI scans to check for brain
swelling or other problems that might be caused by the study
drugs, Carrillo said.
Under new guidelines ironed out through the Alzheimer's
Association's Research Roundtable -- which included both
industry and academic researchers -- the FDA has now eased
those guidelines, Carrillo said in a telephone interview.
Many companies, including Pfizer and J&J and Eli Lilly
(LLY.N), are working to develop drugs that reduce levels of
Carrillo said the new guidelines -- based on the latest
research -- recognize that many patients with Alzheimer's
disease have had these types of brain events, and excluding so
many people from clinical trials would make it more difficult
to find effective drugs.
"We were able to bring together all of the literature
involved in the discussion of MRI abnormalities that could
occur when you are aging with Alzheimer's disease and when you
are participating in clinical trials with an amyloid-modifying
Carrillo said the group of industry experts and researchers
submitted their report to the FDA, which has adopted the new
recommendations. The report was published on Tuesday in the
journal Alzheimer's and Dementia.
The new guidelines allow some patients who develop brain
swelling to stay in clinical trials, she said.
"We don't want to compromise safety, but we also want to
make sure as many people as possible can participate in
Alzheimer's clinical trials," Carrillo said.
In January, Eli Lilly said one patient in ongoing trials of
the company's drug solanezumab temporarily developed brain
swelling, although it was not clear whether the patient was
taking the Lilly drug or a placebo. The problem was not seen in
a follow-up brain scan and the patient resumed treatment.
Rachel Schindler, an Alzheimer's disease expert at Pfizer
who worked on the study and wrote an editorial in the journal,
said, "broadening the restrictions would allow a better
understanding of the potential risks and benefits of
In May, J&J said it plans to seek U.S. regulatory approval
for bapineuzumab in 2012 or 2013, but analysts have said more
studies may be needed because of issues with brain swelling.
Currently, there are no drugs that alter the course of
Alzheimer's, which affects 26 million people globally and costs
more than $600 billion a year to treat.
(Editing by Eric Walsh)
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