Pre-Competitive Consortium to Develop, Standardize, and Validate Preclinical Aged Canine Model of AD

January 02, 2013ST. LOUIS, TORONTO & BOSTON - C2N Diagnostics, InterVivo Solutions, and inviCRO (“Companies”) today announced the formation of a pre-competitive consortium to develop, standardize, and validate an aged-canine model of Alzheimer’s disease (AD) progression. The multi-year collaboration is believed to be the first-of-its-kind. It will rely on the longitudinal measurement of disease-specific and clinically relevant biomarkers in canine aging. The study is modeled after the Alzheimer’s Disease Neuroimaging Initiative (ADNI) initiative in humans. The characterization of AD relevant biomarkers in a preclinical model of disease aims to create a robust and reliable method for the screening of candidate therapies that may prevent, slow, or reverse Alzheimer’s pathology and symptomology. Ultimately, the work from this collaboration intends to improve the translatability of Alzheimer’s preclinical drug development to human drug development.

The longitudinal study will establish temporal patterns of AD biomarkers in canine aging. Markers will derive from cerebrospinal fluid and blood, brain imaging, and cognition / behavioral measures. These markers will be used for establishing criteria for selecting clinically relevant sub-populations of aged dogs for therapeutic screening studies. The study will also establish pre-clinical biomarkers that predict clinical outcomes of disease modifying AD therapeutics.

The three contract research organizations that have formed this consortium have industry-leading expertise relevant to the project. They will work in coordinated fashion to standardize the model and create an extensive repository of benchmark data. Industry and academic collaborators will be able to rely upon these data in the future for reference:

• C₂N Diagnostics will serve as the bioanalytical core lab, performing and overseeing interpretation of all biomarker measurements from the samples collected throughout the multi-year term of the study. C₂N will also contribute to the consortium its proprietary stable isotope labeling (SILK™) methods to measure the kinetics of brain-derived proteins and its absolute protein quantification techniques using mass spectrometry (SISAQ™) to measure levels of beta-amyloid isoforms and the tau protein.
• InterVivo Solutions will be responsible for all administrative oversight of the project. They will serve as the primary liaison among members of the consortium and with parties from industry. InterVivo will also serve as the in vivo service provider including managing cognitive data collection and interpretation, collection of biological samples, and acquisition of the in vivo imaging data.
• inviCRO will develop a 3D canine anatomical atlas and provide advanced imaging analysis . In addition, inviCRO will maintain and provide secured access to in vivo imaging data collected during the project.

Stated Joseph Araujo, CEO of InterVivo Solutions and Manager of the consortium, “We have worked hard to bring together this consortium. In our view, the research service companies represented here are best positioned to successfully carry out the multiple dimensions of this multi-year study. InterVivo has a long track record of providing translational animal models. We aid companies in the development of innovative treatment approaches for disorders of the central nervous system. This consortium represents one of our most exciting projects yet. We anticipate a key outcome from this project being the standardization and validation of a preclinical model of disease that his highly relevant to the human AD condition.”

Joel B. Braunstein, MD, CEO of C₂N Diagnostics added, “We look forward with great enthusiasm to serving as the bioanalytical core lab within the consortium. In addition to providing novel insights around disease progression and natural aging in canines, we expect this study to support the characterization of highly impactful diagnostic and therapeutic biomarkers.”

The consortium is expected to grow over the ensuing months as industry and foundation partners join the effort. New partners will bring financial support and/or in-kind resources to achieve the goals of the initiative. Working with the consortium will afford new members unique access to data, a repository of samples for future biomarker discovery and testing, and participation in a network focused on developing novel therapies for AD. Key findings from the study will be disseminated to the scientific community through presentations at medical meetings and publications in peer-reviewed journals.

Interested parties should direct statements of interest or additional questions to josepha@intervivo.com.

About C₂N Diagnostics

C₂N Diagnostics, LLC (www.c2ndiagnostics.com) formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C₂N is developing a suite of novel biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s products include the SILK-Aβ®, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and absolute quantitation of brain derived proteins. Beyond AD, products are in development to target Parkinson’s disease, Huntington’s disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, please contact info@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

About InterVivo Solutions

InterVivo Solutions, Inc (www.intervivo.com) formed in 2010 as a spin-out company of CanCog Solutions, Inc. with the goal of commercializing in vivo pre-clinical contract services and models for the human therapeutic development market. InterVivo’s mission is to develop and provide translational animal models for establishing proof of concept efficacy of therapeutics targeting human diseases of the nervous system and for assessing early safety. InterVivo strives to provide predictive animal models in appropriate species to improve the successful transition of new therapeutics from preclinical through to clinical trials. The company provides rodent models of cognitive function and aging, pain and epilepsy, obesity and addiction, and Parkinson’s disease. InterVivo also provides naturalistic canine models of human diseases with a particular emphasis on AD progression, cancer, osteoarthritis, obesity and metabolic disorder. For additional information, please contact info@intervivo.com.

About inviCRO

inviCRO, LLC (www.invicro.com) is a Boston-based CRO that offers a range of imaging services and software solutions designed to further the functionality of imaging in research in medicine. inviCRO manages more than 12 studies per month and processes more than 25,000 tomograms per quarter. inviCRO software products are used by more than 100 imaging laboratories worldwide including more than half of the top 25 pharmaceutical companies. inviCRO has grown organically to employ 22 researchers from a broad range of disciplines including advanced degrees in: physics, optics, software engineering, electrical engineering, chemical engineering, mathematics, neuroscience, biomedical engineering and statistics. For additional information, please contact info@invicro.com.