- Published: April 2012
Prospects for the Phase III Bapineuzumab Trial
- Published: September 2009
- Region: World
- 37 Pages
- FirstLine Consulting Group
One of the most watched clinical trials is the phase III trial for bapineuzumab, a humanized monoclonal antibody designed to bind to and remove Aß in the blood and in the brain. Concerns have arisen over bapineuzumab phase II data presented last year in which extensive subanalysis was performed indicating strong efficacy in some subgroups. However, the subanalysis is viewed by some to be misleading. To understand the value of the phase II trial and the potential for success for the phase III trial, we performed a comprehensive analysis on the major issues of the trial. In our analysis, we have:
- Researched bapineuzumab phase I and phase II results in depth, and collected vast amounts of information that have helped us assess the true risk to safety and efficacy of the phase III trial.
- Consulted with many clinicians, as well as thoroughly researched comparative phase II and III trials to gain perspective on the results obtained with bapineuzumab so far.
- Carefully analyzed the perceived higher decline of ADAS-cog scores in the placebo arm and found surprising results.
- Investigated the apparent lack of dose response in the phase II trial and compared this to other biologic therapies.
- Assessed the safety issues of the phase III trial and how they may affect ultimate usage.
Our research produces unexpected conclusions about the potential for efficacy and risks of the phase III bapineuzumab trials. The research provided will help investors and companies alike to strategize efforts and investment in the Alzheimer’s disease market SHOW LESS READ MORE >
Causes of the Disease
Aß Plaques Theory of Alzheimer’s Disease
Theory Involging Aß and ADDLs
Neurofibrillary Tangles Theory
Mitochondrial Destabilization Theory
Cerebral Amyloid Angiopathy
How AD Is Diagnosed (adapted from Health and Human Services and Alzheimer’s Association)
Mental Status Tests
Functional Activities Questionnaire
Endpoints Used To Assess Efficacy Of AD Drugs
Symptomatic Trials In Very Early, Mild, And Moderate AD
Disease-Modifying Trials In Very Early, Mild, And Moderate AD
Trials in Severe AD
Current Treatment of Alzheimers Disease
Clinical Trials of Bapineuzumab
Phase II trial
Post Hoc Subset Analysis of Phase II Results
Safety in Phase II Study
Phase III Clinical Trials
What Is Likelihood That Phase III Will Show Positive Outcome, At Least In Apoe4 Non Carriers?
Was There a Greater Than Usual Decline In Placebo Group?
Lack of Dose Response
How Predictive Were Phase II Trials For Existing Therapies?
How Other Antibodies Have Performed in Phase II
Lilly- LLY2062430, solanezumab
- Forest Labs
- Sciele Pharma
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