Phase 2 Trial of Immunotherapy in Alzheimer's Disease Offers Encouraging Results
(June 18, 2008) - Preliminary results from a Phase 2 trial of bapineuzumab (AAB-001) were released by the sponsoring companies Elan and Wyeth on June 17, 2008. The findings revealed statistically significant and clinically meaningful differences between drug and placebo groups in an identified subgroup of the study population: non-carriers of the Apolipoprotein E4 (ApoE-4). Although statistically significant differences on efficacy measures were not observed in the general study population, the findings from the subgroup analyses suggest that bapineuzumab, a humanized monoclonal antibody that was designed to clear beta-amyloid from the brain, has the potential to offer meaningful benefits for patients with Alzheimer’s disease who do not carry the ApoE-4 gene.
Safety data from the Phase 2 trial showed similar rates of serious adverse events between the placebo group and ApoE-4 non-carriers treated with bapineuzumab. When comparing ApoE-4 carriers treated with bapineuzumab to patients taking placebo, however, an elevated rate of serious adverse events was found in the treatment group. Of particular notice was vasogenic edema, a type of swelling of the brain, which occurred only in patients treated with bapineuzumab, and at higher rates in ApoE-4 carriers and patients treated at higher doses. Largely due to these differences in the rate of serious adverse events, the ongoing Phase 3 studies were designed so that ApoE-4 carriers are given lower doses of bapineuzumab with the hopes of mitigating the risk of these serious adverse events.
For more information related to the Phase 2 results and ongoing Phase 3 study, please go to the following links:
USA Today: Promising Alzheimer’s Drug Approved for Late-Stage Trials, June 17, 2008
Business Week: Alzheimer’s Drug Shows Progress, June 18, 2008
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