Global Standardization for Alzheimer's Biomarkers Moves a Major Step Closer to Reality

NEW YORK, August 11, 2011 /PRNewswire/ --

Alzheimer's Association Analysis of APOE-e4 on amyloid deposits shows abnormal levels can be detected at least 10-years and possibly 20-years prior to onset

Citeline, an Informa business unit, and the world's leading research authority on pharmaceutical clinical trials recently reviewed the findings from the 14th International Conference on Alzheimer's Disease (ICAD 2011/AAIC 2011) July 16-21, 2011, noting that while pharma continues to develop beta amyloid targeting drugs, amyloid targets are moving ahead in terms of biomarkers and early warning for risk of Alzheimer's.

According to Dr. Revati Tatake, CNS Analyst at Citeline, noteworthy among the biomarkers/genomics-focused on-going studies were multiple studies under the worldwide initiative, "Alzheimer's Disease Neuroimaging Initiative (ADNI)", spearheaded by the Alzheimer's Association in an effort to globally standardize Alzheimer's biomarkers, and the "Dominantly Inherited Alzheimer's Network (DIAN)" study.  The results from three ADNI studies from different countries suggested that a worldwide ADNI data set can be used for combined analysis of APOE-e4 on amyloid deposition, a step closer to the goal of global standardization of biomarkers. The DIAN study has a slightly different focus and indicated that abnormal levels of CSF amyloid-beta42 and tau protein, brain chemistry and imaging changes can be detected at least 10 years and up to 20 years before the expected onset of Alzheimer's in the subjects with genetic predisposition.

"The progress in Alzheimer's biomarkers/genomics field is especially significant as several clinical studies involving anti-Alzheimer's drugs are investigating CSF/plasma/brain amyloid-beta levels as one of the major efficacy biomarkers and using APOE-e4 genotype for stratifying patients for the treatment," commented Dr. Tatake.  In fact out of the 40 abstracts involving pipeline drugs presented at this meeting, 14 trials contained analysis of biomarker and/or genomic parameters.

A late breaking report concerning long-term safety results of an ongoing Phase II trial of bapineuzumab beyond 78 weeks is worth mentioning.  The long term safety data that bapineuzumab was generally well-tolerated and side-effects tended to be mild and less frequent over time are certainly encouraging, as bapineuzumab is one of the most advanced anti- beta amyloid antibodies that are in clinical development.  Bapineuzumab, jointly developed by Pfizer and J&J, is currently in several ongoing pivotal trials.

Among other approaches targeting the beta amyloid pathway, AFFiRiS/GSK presented safety data for active immunotherapy approach by AFFITOPE AD02.  Bristol-Myers Squibb and Chiesi presented safety and tolerably results of their gamma secretase inhibitors, avagacestat (BMS-708163) and CHF-5074, respectively.   The safety results of gamma secretase inhibitors are particularly important in light of termination of pivotal trials of Lilly's gamma secretase inhibitor, semagacestat, for safety reasons. "It remains to be seen if Lilly's termination of semagacestat has impacted/will impact the course for other gamma secretase inhibitors that are in clinical development," added Dr. Tatake.

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