Trial of Alzheimer's Vaccine Suspended
By Biotechdaily staff writers
Posted on 20 May 2002
A phase 2A clinical trial of an experimental immunotherapeutic for the treatment of mild- to-moderate Alzheimer's disease has been suspended by the company sponsors because four patients appear to have inflammation in the central nervous system. Posted on 20 May 2002
The four patients, in France, are receiving appropriate medical care and the companies are working with clinical investigators to determine the cause of this development. Trials were being conducted in the US and four European countries of the immunotherapeutic, called AN-1792. To date, about 360 patients have received multiple doses of AN-1792.
The presence of virus within the cerebrospinal fluid was reported in some of the four patients. However, the cause of the inflammation remains to be determined.
In Phase 1 safety studies, the drug was administered to more than 80 patients and was well tolerated, with some patients developing an appropriate immunologic response to the drug. The trials are being sponsored by Elan Corp. (Dublin, Ireland) and Wyeth-Ayerst Laboratories (Madison, NJ, USA) in a collaborative effort. The phase 2A study was designed to measure the immune response of Alzheimer's patients to beta amyloid peptide immunization.
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