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http://dailynews.yahoo.com/h/nm/20020118/sc/health_elan_dc_2.html
Friday January 18 10:24 AM
ET
By Ben Hirschler and
Michael Roddy
LONDON/DUBLIN (Reuters) - Hopes for a new
vaccine to treat Alzheimer's disease suffered a setback on Friday when the
Irish drug firm behind the product announced it had temporarily suspended
trials after four patients fell sick.
Elan Corp stock slumped 15 percent in early
trade in New York, where most of its shares change hands, as investors fretted
that the pioneering vaccine, being developed with American Home Products Corp,
might never make it to the market.
The drug, dubbed AN-1792, was hailed last
year as a potential breakthrough in treating and possibly curing Alzheimer's,
after studies in mice showed it could clear the brain-clogging plaques that are
a hallmark of the disease.
It is designed to stimulate the body's immune
system to destroy the build-up of waxy proteins found in the brains of people
suffering from the debilitating disorder.
But news that four out of 97 patients in
France had suffered from inflammation of the central nervous system after being
given the vaccine suggests it may have unwanted side effects. Some 360 patients
have so far received the drug worldwide.
Elan said it would suspend dosing in the
Phase IIa trials until the cause of the inflammation could be determined,
although the study itself would continue.
``Our decision to temporarily suspend further
dosing, pending the results of our evaluation, is a standard approach to
protect the safety of patients in clinical trials,'' said Dr. Ivan Lieberburg,
Elan's chief scientific and medical officer.
Given the intermittent nature of the
injections, Elan hopes the problem can be resolved without jeopardizing the
conduct of the study.
The current trials, which began in the latter
part of 2001 and had been expected to last around two years, follow successful
Phase I safety tests on more than 80 patients. Drugs need to pass through three
sets of clinical trials before they are ready for approval.
HIGH-RISK PROJECT
Industry analysts said the problem with
AN-1792 was a blow to Elan since the drug -- together with Antegren for
multiple sclerosis -- was viewed as the most exciting to emerge from the company's
in-house research.
But Max Hermann of ING Barings in London said
the market was over-reacting and reiterated his ``buy'' recommendation, despite
a $6.82 fall in Elan shares to $38 on the New York Stock Exchange by 1500 GMT.
They had earlier lost 12 percent in Europe.
``It's a disappointment but AN-1792 was
always going to be very high-risk,'' he said.
A Dublin-based analyst agreed. ``It's one of
the biggest pipeline projects but it's far enough from the market that nobody's
factored any revenues in for it,'' he said.
AN-1792 is one of three therapeutic vaccine
approaches being developed by Elan and American Home Products' Wyeth-Ayerst
Laboratories unit to fight Alzheimer's, a progressive disease which leads
eventually to profound dementia.
Around four million people in the United
States alone suffer from the disease, and the Alzheimer's Association predicts
the number of American sufferers will increase to 14 million by 2050 unless a
prevention or cure is found.
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