Positive Interim Results From Phase III Trial of Amyloid Imaging Agent Florbetapir F18 Presented at American Academy of Neuro...
Avid Radiopharmaceuticals, Inc. (“Avid”) today announced the presentation of interim data from its landmark florbetapir “Image-to-Autopsy” Phase III study. These data come from the first cohort of subjects in the trial and are the first ever Phase III results for an agent designed to image Alzheimer’s disease pathology. Today, Alzheimer’s disease can only be definitely diagnosed by microscopic detection of beta-amyloid at autopsy. The goal of Avid’s Phase III trial is to test the ability of florbetapir to image beta-amyloid in living patients.
The interim data showed that florbetapir PET imaging results in patients correlated with the levels of beta-amyloid pathology later found in their brains at autopsy. Dr. Adam Fleisher, Associate Director of Brain Imaging at Banner Alzheimer’s Institute, presented the analysis at the 2010 Annual Meeting of the American Academy of Neurology in Toronto, ON.
Dr. Fleisher commented “These preliminary results are very encouraging for the field of amyloid imaging and the future management of Alzheimer’s disease. The data suggest that florbetapir imaging may offer an opportunity to detect amyloid plaques in-life. Knowing if a patient has Alzheimer’s pathology might lead to better patient management -- for example, if a patient has memory loss but no amyloid pathology, we could rule-out Alzheimer’s disease, and instead focus on looking for other causes for their symptoms.”
Dr. Fleisher reported the results from the analysis of the first six subjects of the florbetapir “Image-to-Autopsy” Phase III study. The data from this cohort demonstrated that the florbetapir PET images correlated strongly with the post mortem histopathology findings. The PET images not only correctly identified which subjects had beta-amyloid deposits, but also showed where in the brain the deposits had accumulated. The full trial data are expected to be available later this year.
Avid’s florbetapir was the first beta-amyloid imaging compound to enter multi-center, IND clinical studies in the U.S., and has now been studied in more than a dozen trials in over 700 subjects ranging from cognitively normal individuals to those with Alzheimer’s dementia. As well as the pivotal Phase III Image-to-Autopsy study, additional clinical studies in the E.U., South America, Australia and Asia are also being conducted.
About Alzheimer’s Disease and Beta-Amyloid Plaque Deposits
Alzheimer’s disease, a chronic neurodegenerative condition that currently affects over 5 million Americans1, cannot be definitively diagnosed until after death, when a brain autopsy is performed on a patient and evidence of beta-amyloid plaque deposits in the brain – which are a hallmark pathology of the disease – can be found. Accurate diagnosis during life can be challenging, particularly in the early stages of disease, when symptoms are mild and non-definitive and can be mistaken for those of other treatable conditions. Florbetapir, used with positron emission tomography (PET) technology is being assessed for the ability to detect beta-amyloid plaque deposits in-vivo, potentially offering clinically useful diagnostic insight at an early stage.
About Avid Radiopharmaceuticals, Inc.
Avid Radiopharmaceuticals is a leader in the development of molecular imaging products with the potential for earlier and more effective detection, diagnosis and monitoring of major chronic human diseases. Based in Philadelphia, PA, the company is a pioneer in the development of molecular imaging agents for Alzheimer’s disease that could lead to earlier diagnosis and better evaluation of drugs designed to prevent or reverse beta-amyloid plaque build-up in the brain. As well as florbetapir, Avid is currently conducting Phase I and II trials with 18F-AV-133 for imaging the vesicular monoamine transporter (VMAT2) in diseases involving dopaminergic degeneration (Parkinson’s disease and Dementia with Lewy Bodies) and beta cell dysfunction (Type I and Type II Diabetes Mellitus). More information about Avid is available at www.avidrp.com.
1 Source: Alzheimer's Association 2010 Alzheimer's Disease Facts and Figures
“Those who don't know history are destined to repeat it.”
Edmund Burke (British Statesman and Philosopher, 1729-1797
