Alzheimer's Drug Is Found Safe Enough For Elan to Start Wider Clinical Trials
By ANTONIO REGALADO
Staff Reporter of THE WALL STREET JOURNAL
Initial human tests of an unconventional treatment for Alzheimer's disease show the drug is safe enough to enter expanded clinical trials. Its developer, Elan Corp., said it would announce the results Monday.
In tests on about 100 elderly patients with moderate forms of Alzheimer's disease, AN-1792 caused no major side effects, according to the company. The drug is designed to stimulate the body to destroy the brain plaque that causes Alzheimer's. Ivan Lieberburg, Elan's chief scientific and medical officer, said the study found evidence of a beneficial immune response. A larger study is set to be launched this fall, and will involve 375 patients in the U.S. and Europe.
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According to the Centers for Disease Control and Prevention in Atlanta, Alzheimer's disease ranks as the eighth-leading cause of death in the U.S., and accounted for 44,507 deaths in 1999.
Elan, Dublin, Ireland, is developing AN-1792 along with American Home Products Corp. of Madison, N.J. The partners are conducting preliminary animal tests on several related compounds, and Dr. Lieberburg said he expected to ask the Food and Drug Administration for permission to begin testing two of those sometime next year. Further human studies will show which member of the drug family works best.
The progress of AN-1792 is being closely watched by many scientists, since the experimental drug contains the same molecule that is believed to cause Alzheimer's when it builds up in the brain. Elan scientists believe the treatment teaches the body's immune system to eliminate the harmful molecule, known as beta-amyloid.
In the new study, Elan says it will seek further data on the drug's safety and proper dosage. Elan will also test some new ideas for measuring anti-Alzheimer's effects, including imaging patients' brains with magnetic resonance imaging, or MRI.
"For a first-in-its-class drug like this, the biggest challenge is in not exactly knowing what you are going to see," said L. Patrick Gage, president of research at AHP's pharmaceutical division, Wyeth-Ayerst Laboratories. "We think this clinical study is important to help us know how to better design" future human tests.
In related news, scientists at University College London reported in the July issue of the Lancet that they used MRI to detect the onset of Alzheimer's disease in patients about three years before they began to experience clinical symptoms, such as memory loss. |
