Alzheimer’s Disease Vaccine Tests Ended on Safety Concerns |
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By Rich O’Boyle, Publisher The much-watched Alzheimer's Disease vaccine trials have been cancelled after 15 patients developed a serious brain inflammation. Elan Pharmaceuticals announced on March 1, 2002 that due to safety concerns, the developmental vaccine, AN-1792 (also known as AIP-001), would no longer be administered to patients. In January Elan suspended the ongoing Phase II clinical trials into their experimental vaccine, when researchers found a handful of individuals who were taking the drug in clinical trials developed unexpected side effects. In later weeks, the number of patients experiencing the dangerous side effects climbed to 15. Now the trials have been cancelled all together. Elan, along with Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation, reported in January that four of the 97 patients taking the drug had developed a severe inflammation in the central nervous system. All patients who experienced this event have, or are, receiving medical care and most have shown improvement or recovered, according to Elan. “We will continue to monitor all patients who have received [the] drug in these studies,” said Dr. Ivan Lieberburg, Elan’s Chief Scientific and Medical Officer on March 1. “The well-being of patients is always our paramount concern. Our decision to first suspend dosing, and now permanently discontinue dosing in this exploratory phase of clinical research with this single compound, in our opinion, remains in the best interest of the health and safety of patients. There are additional compounds under preclinical evaluation as part of this collaboration. We believe that these alternative therapeutic candidates may result in a treatment for Alzheimer’s disease.” Many regarded the drug as a major breakthrough last year when research showed that it actually cleared plaques associated with Alzheimer’s Disease from the brains of experimental mice. According to the Alzheimer Research Forum, two studies performed on mice with a genetic predisposition to developing Alzheimer’s Disease show remarkable results when treated with the vaccine. One study found that virtually all of the mice treated with AN-1792 had no detectable amyloid deposits in their brains compared to controlled groups that had no reduction in the progressive deposition of plaques. Another study showed that the treated mice had significantly less plaque and neuropathology than untreated mice. Recent studies also indicate that vaccination reverses or prevents cognitive deficits in transgenic mice that are susceptible to deposit amyloid plaque. During Phase I clinical studies, the vaccine was found to be safe in patients with mild to moderate Alzheimer’s disease in a variety of dosage regimens. Phase II trials are designed to determine the correct dose at which the vaccine immunizes the patients against the buildup of beta amyloid plaques. Phase III trials are large scale tests designed to gauge long-term efficacy. Additional Resources: Elan Pharmaceuticals Website http://www.elan.com Related Articles: Vaccine
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