Interim Phase III data to be presented on landmark florbetapir-PET imaging and beta-amyloid pathology correlation study
Philadelphia, PA, June 2, 2010 – Avid Radiopharmaceuticals, Inc. announced today that seven oral presentations and three poster presentations will be made about the company’s PET imaging programs in three focus areas — Alzheimer’s disease (“AD”), Dementia with Lewy Bodies (“DLB”) and Diabetes — at the upcoming 2010 Annual Society of Nuclear Medicine (SNM) meeting in Salt Lake City, Utah, beginning Sunday, June 6, 2010.
Avid is a leading company in the development of novel molecular imaging compounds intended for the early detection and monitoring of significant chronic human diseases. Avid has completed enrollment of a landmark “Image-to-Autopsy” Phase III study of florbetapir F 18 (18F-AV-45), its amyloid imaging agent for the detection of the hallmark pathology of AD.
The results from the first cohort of subjects in the Avid Phase III trial showing the correlation between florbetapir-PET scans and the levels of beta-amyloid pathology later found in their brains at autopsy will be presented (June 8, Presentation No. 387). These interim data are the first ever Phase III results for an agent designed to image beta-amyloid aggregates, a defining pathology in AD. Today, AD can only be definitely diagnosed by microscopic detection of beta-amyloid aggregates at autopsy. Full data from this Phase III trial are expected later this year.
Avid’s second pipeline program, VMAT2 imaging of nigrostriatal degeneration with 18F-AV-133 (“AV-133”), is in Phase I and II clinical trials. These early clinical studies have shown encouraging results for the ability of AV-133 to visualize decreases in VMAT2 signal in the brain associated with Parkinson’s disease (“PD”) and DLB. In addition, research studies of AV-133 have shown it to be a marker of VMAT2 on beta cells, the key insulin-secreting cells of the pancreas. New data being presented at this SNM meeting report the specificity of AV-133 VMAT2 binding in rats.
In addition, a Yale study reports preliminary data on the reversibility and specificity of AV-133 binding in rats and preliminary human data to assess the feasibility of imaging beta cells. (June 7, Presentation No. 130). Further clinical data on the performance of AV-133 in differentiating between DLB and AD from research conducted at Austin Health in Melbourne, Australia will also be presented (June 8, Presentation No. 442).
Poster and oral presentations on Avid’s three pipeline programs will be held on the following days:
SUNDAY, JUNE 6, 2010
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No. 53 (Presentation) — A novel approach for semi-quantitative estimation of global amyloid uptake utilizing florbetapir and positron emission tomography. Krishnendu Saha, Avid Radiopharmaceuticals, Philadelphia, PA.
MONDAY, JUNE 7, 2010
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No. 130 (Presentation) — PET imaging of pancreatic beta cell mass with AV-133. Marc Normandin, YaleUniversity, New Haven, CT.
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No. 1291 (Poster) — Quantification of florbetapir-PET imaging in presence of brain atrophy: A comparison of manual and automatic approaches. Grzegorz Romanowicz, Nuclear Medicine Dept, Gdanski Uniwersytet Medyczny, Gdansk, Poland
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No. 1417 (Poster) — A retrospective evaluation of PET scanner properties utilizing brain Hoffman phantom imaging for florbetapir study. Krishnendu Saha, Avid Radiopharmaceuticals, Philadelphia, PA.
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No. 2021 (Presentation) — Beta-amyloid imaging utilizing florbetapir: A technologist’s perspective. Jason Burns, Avid Radiopharmaceuticals, Philadelphia, PA.
TUESDAY, JUNE 8, 2010
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No. 387 (Presentation) — Florbetapir-PET imaging of beta-amyloid plaques is highly correlated with histopathological assays at autopsy.Mark Mintun, Washington University, St. Louis, MO.
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No. 442 (Presentation) — Differential diagnosis of dementia with Lewy bodies from AD using AV-133, a novel PET tracer for VMAT2. Victor Villemagne, Centre for PET, AustinHospital, Melbourne, VIC, Australia.
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No. 1441 (Poster) — Human biodistribution and radiation dosimetry of AV-133: A novel vesicular monoamine transporter 2 agent.
Kun-Ju Lin, Nuclear Medicine, ChangGungUniversity and ChangGungMemorialHospital, Taipei, Taiwan.
WEDNESDAY, JUNE 9, 2010
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No. 570 (Presentation) — Validation of a novel PET method for quantization of amyloid pathology. Grzegorz Romanowicz, Gdanski Uniwersytet Medyczny, Gdansk, Poland.
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No. 584 (Presentation) — A comparative dynamic PET imaging of monkey brains between solid phase extraction and HPLC purified AV-133. Lin Zhu, College of Chemistry, BeijingNormalUniversity, Beijing, China.
“This has been a year of great progress with our development pipeline. Florbetapir and AV-133 will be the focus of several different presentations at this year’s SNM scientific program,” said Daniel M. Skovronsky, MD, PhD, Founder and CEO of Avid. “I am really excited to see the acceleration of new developments in PET imaging compounds with the potential to identify patients who will most benefit from early intervention in major diseases.”
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’s lead program is a molecular imaging agent for amyloid plaque that could lead to earlier detection and better evaluation of drugs designed to prevent or reverse amyloid plaque build-up in the brain. Avid is currently conducting Phase III clinical studies of florbetapir for imaging amyloid plaques in Alzheimer's disease, and is in 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). For more information, please visit www.avidrp.com.