Phase 3 Intraveneous Bapineuzumab Clinical Trial Results

Posted Friday, July 27, 2012

Source: Butler Hospital

On July 23, 2012, Pfizer Inc. announced the results of a Phase 3 trial of intravenous (IV) bapineuzumab in the Janssen Alzheimer's Immunotherapy R&D LLC-led research study. Pfizer and Janssen AI are partners in the Alzheimer's Immunotherapy Program (AIP). Pfizer reports that no statistically significant benefit in cognitive or functional performance was seen in the 18-month trial of bapineuzumab-treated participants who carry the ApoE4 (apolipoprotein E epsilon 4) gene, which is known to increase risk of Alzheimer's disease and potentially affect its severity. Results of a second 18-month study which tested the effects of bapineuzumab on cognitive and functional performance in participants who did not carry the ApoE4 gene are expected later this summer.

"We are very disappointed about the lack of clinical efficacy in the ApoE4 carriers at the stage of mild to moderate dementia. However, we are hopeful that we might see a more positive clinical result in the ApoE4 non-carriers, as we reported in an exploratory analysis in an earlier phase 2 study with bapineuzumab," said Stephen Salloway, MD, director of Neurology and the Memory and Aging Program at Butler Hospital, and professor of Neurology and Psychiatry at the Warren Alpert Medical School of Brown University.  Salloway chairs the steering committee for these Janssen phase 3 trials of bapineuzumab. "We eagerly await the biomarker evidence, including PET amyloid imaging and spinal fluid markers, to determine whether there are any signals suggestive of disease-modifying activity that might support further investigation into earlier intervention." The results, including biomarker data, were accepted as a late-breaker and will be presented at the European Federation of Neurological Societies in Stockholm, Sweden in September.

Filed under: Neurosciences Institute,