Will the outcome of the bapineuzumab Phase III pivotal trials give relief to our intense interest in biomarkers?



As Exploratory Clinical Development World Europe 2012 is based with our Biomarker World Europe event, I thought it would be interesting to comment on today's news on the development of Bapineuzumab, a therpy which was confirmed to lower Amyloid in a PIB-PET biomarker study.

Elan today announced that their CEO, Kelly Martin, was staying on to take responsibility of the big Phase III program, which the company still has a 25% stake in after J&J and Pfizer agreed to drive development. The study is due in the mid-year and the Pfizer R&D chief, Mikael Dolsten, has already said that the data so far has been more compelling than Eli Lilly's Solanezumab. However the Alzheimer's arena is littered with failures, so we shouldn't hold our breath.

Looking back at the early clinical study, these ongoing Phase 3 trials were based on live brain imaging which confirmed anti-A(beta) peptides could help shrink amyloid plaques in the brains of Alzheimers patients. The ultimate test is whether these biomarkers studies are linked with a functional benefit in patients. This is a huge missing link and would it be so bold to state that this is a common occurrence in many biomarker investigations? How can we avoid this? Is it a question of getting the initial biomarker studies right – in the early bapineuzumab studies many investigator have speculated the PIB-PET imaging likely affected the outcome by enabling the investigators to scrap potential participants on the basis of their baseline amyloid load. The power of PET amyloid imaging was to select people who have pathology in order to maximise the chance of a drug effect, but maybe some excluded people wont necessarily PIB-negative. Very interesting opinions in this article – http://www.alzforum.org/new/detail.asp?id=2389

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