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Elan Inc. Halts Alzheimer’s Trial

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Shares in Elan Inc. dropped 62 cents after the company said it was stopping clinical trials of an Alzheimer’s disease vaccine after a patient developed an unexplained skin disorder. Following the announcement, Elan’s American Depositary Receipts – securities that allow U.S. investors to trade shares of companies based overseas – fell 2.6 percent, to $23.68. Shares in Wyeth Pharmaceuticals – which was developing the drug with Elan – slipped 33 cents to $43.90.

That followed a recent up-tick in Elan’s stock after the company announced a stronger-than-expected increase in the number of patients treated with its controversial multiple sclerosis (MS) drug Tysabri. Tysabri had actually been removed from the market in 2005 because several patients taking it had died from a neurological disorder called progressive multi-focal leukoencephalopathy. The FDA later re-approved Tysabri in 2006, after deciding that benefits in slowing MS relapses outweighed Tysabri risks. In February, Elan and Biogen Idec, its partner in Tysabri, warned that the drug had also been linked to instances of serious liver failure.

The halted clinical trials involved ACC-001, a vaccine designed to help the body’s immune system create antibodies against beta amyloid, the toxic protein that forms plaques in the brain believed to play a key role in Alzheimer’s disease. ACC-001 is a second-generation version of another Alzheimer’s vaccine, AN1792. Work on that vaccine was stopped in 2001 after some patients were hospitalized due to swelling in the brain.

According to Elan, clinical trials for ACC-001 were halted after a patient developed unexplained skin lesions and had to be hospitalized. It was thought the skin lesions may have been vasculitis, an inflammation of the blood vessels that can be caused by an immune reaction. But a Wyeth spokesperson told TheStreet.com that a biopsy did not confirm the disorder. The patient in question has since recovered.

According to The Wall Street Journal, the companies said the suspension came after discussions with Food and Drug Administration. Elan and Wyeth have also voluntarily suspended studies on ACC-001 that were taking place outside of the U.S. However, the companies are not saying the clinical trial suspensions are permanent.

Elan said the problems with ACC-001 are not affecting clinical trials for bapineuzumab, another promising Alzheimer’s treatment it is developing with Wyeth. An early, small study suggested bapineuzumab has potential to improve cognitive function in Alzheimer’s patients, though the drug has also been associated with a fluid buildup in the brain.

Alzheimer’s disease is a progressive and fatal that disorder destroys brain cells, causing problems with memory, thinking and behavior severe enough to affect work, lifelong hobbies or social life. As many as 5 million Americans are living with Alzheimer’s disease, and it is the seventh-leading cause of death in the US. According to The Wall Street Journal, sales of a drug that significantly improves treatment could reach into the billions of dollars.

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