Advances in Imaging Biomarkers: Innovative Technologies, Applications in R&D and Clinical Practice, and Informatics and Regulatory Requirements

22 Jul 2010 • by Natalie Aster

Alseres Pharmaceuticals is developing Altropane, a I-labeled small molecule with high selectivity for the Dopamine Transporter (DAT), which can be imaged using SPECT. A SPECT scan using Altropane visibly displays DATs on the surface of the dopamine neurons providing insight into the number of DATs present. A low signal with Altropane suggests low DAT levels and therefore low numbers of dopamine- producing neurons, a hallmark of PD. The company has designed to demonstrate that SPECT scans of individuals with Parkinson's disease show a marked decrease in the binding of Altropane when compared with individuals without loss of these neurons.

Five clinical studies testing nearly 500 individuals have been completed using Altropane as a molecular imaging agent. Results from the completed studies met their endpoints with statistical significance. The results of the Phase III POET-1 clinical trial, announced in 2006, showed that diagnosis from Altropane scans had statistically significant superiority over the diagnosis of general practitioners on measures of both specificity and sensitivity. A second Phase III trial (POET-2) is now underway and enrolment of patients in the first stage of the trial, which aims to acquire the set of Altropane images to train expert readers for the Phase III registration portion of the program, completed in February 2009. In April 2009, the company announced that it had agreed a Special Protocol Assessment with the FDA to define the size, design and analysis of clinical trials that will form the primary basis of approval. 123I-Altropane is also in development as an imaging biomarker for Dementia with Lewy Bodies and Attention Deficit Hyperactivity Disorder.

Alseres is also developing second-generation molecular imaging agents highly selective for DAT that incorporate technetium (99m Tc) as the radiolabel. This label offers advantages over 123 I, as it is relatively inexpensive, has a short but useful half- life, and is readily available from portable generators at nuclear pharmacies or the imaging site.

Imaging biomarkers in clinical practice: cardiovascular disease

The development of imaging biomarkers for diagnosis and management of cardiovascular disorders is somewhat behind efforts in the fields of oncology and neurology. Nevertheless, there are a large number of ongoing research projects to develop new biomarkers and to conduct the relevant clinical studies to establish their use in clinical care. Key areas of development include the measurement of stenosis, assessing the condition of atherosclerotic plaque and imaging heart function. Growth in the use of imaging to diagnose and manage heart disease mirrors the evolving understanding of the underlying causes of the disease and the growing realization that the ability to create a picture of the disease early on, before major arteries are blocked, would be highly advantageous.

More information on advances in imaging biomakers you can find from the report “Advances in Imaging Biomarkers: Innovative Technologies, Applications in R&D and Clinical Practice, and Informatics and Regulatory Requirements” published by Business Insights.

“Advances in Imaging Biomarkers: Innovative Technologies, Applications in R&D and Clinical Practice, and Informatics and Regulatory Requirements”

Published: July, 2010
Pages: 198
Price: US$ 3,835.00


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