Glasgow, UK, February 7, 2012 / B3C newswire / - Sistemic is delighted to announce that its proprietary technology (SistemQC™) has been chosen to form a key part of the research and production process for a landmark multinational collaborative project led by TiGenix, Belgium and including partners from Spain, France, the Netherlands as well as the UK and Belgium. The project, REGENER-AR, will bring the first stem cell therapy treatment product for rheumatoid arthritis, Cx611, through final research and clinical development.
The proprietary SistemQC™ miRNA-based stem cell characterization and quality control tool-kit will provide important insights into process optimization and QC testing of TiGenix’s pioneering cell therapy product. This work is part of a larger collaborative effort led by TiGenix and funded by a EUR 5.9 million European Seventh Framework Programme (FP7) grant under the topic “Regenerative medicine clinical trials” within the Health theme.
SistemQC™ combines robust miRNA profiling with superior statistical analytics and multi-layered contextual analysis to generate a fingerprint of key miRNAs (kmiR™s). This approach provides a succinct read out on the status of the cells, with the added benefit of being able to interpret the underlying biological effects associated with any change observed. Additionally, the kmiR™ fingerprints can be adapted to a QPCR method for ease of integration into laboratory routine, and provide rapid testing. They can be used as a cell phenotype characterization tool in combination with a qualitative assessment of product cell composition, or to monitor product quality during scale-up and aid the selection of manufacturing process improvements.
Dr Vincent O’Brien, Sistemic’s Chief Science Officer said, “We are honoured to be working with TiGenix and Cellerix, its Spanish subsidiary as well as partners from all over Europe. Sistemic will provide in-depth product characterization data during the clinical trial with Cx611. This will be a critical part of the development and subsequent production process. We look forward to collaborating with all of the consortium members on this important project as we are supportive of the potential of cell therapy products to bring real benefits to those patients suffering from rheumatoid arthritis.”
The collaborative project, referred to as the REGENER-AR consortium, brings together 10 top-level research institutes, medical entities and biotechnology companies from Spain, France, the UK, the Netherlands and Belgium. The consortium has defined a clinical translational project with the aim of developing a broadly available, clinically applicable treatment for rheumatoid arthritis by exploiting human allogeneic mesenchymnal adult stem cells extracted from adipose tissue (eASCs).
Sistemic provides innovative miRNA-based products to the cell therapy, drug development and bioprocessing markets. The company’s pioneering approach enables companies to accelerate drug discovery and development programmes whilst reducing development risk. For further information visit: www.sistemic.co.uk
Sistemic is a registered trademark of Sistemic UK
SistemQC™ and kmiR™ are trademarks of Sistemic UK
About Sistemic Ltd.
Sistemic is focused on providing innovative microRNA-based problem-solving services to areas of unmet need within Pharmaceutical and Biotechnology R&D and manufacturing. MicroRNAs are perceived as the master controllers of the cell and mediate a wide range of cell functions and responses. Sistemic has developed miRNA profiling technology where a cell’s whole microRNA response to a stimulus (chemical or biological) can be analysed, interpreted, compared to the Sistemic Knowledgebase of miRNA response and then provided to the client as useful and functional data. In this way a cell can be subjected to a single assay and its full biological response can be obtained, to give the client a more complete understanding of their system.
TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with two marketed products, ChondroCelect and ChondroMimetic, and a strong pipeline with clinical stage adipose stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium), and Madrid (Spain), and has facilities in Cambridge (UK) and Sittard-Geleen (the Netherlands).
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Contact Sistemic UK Ltd.
Dr Verna McErlane
Director of Commercial Operations International
Thomson Building, Gilmorehill
Glasgow, UK, G12 8QQ
Tel: +44 7855376358
Sistemic US Ltd.
28 State Street, Suite 2300
Boston, USA, MA 02109
Tel: +1 (0) 617 523 3272
Fax: +1 (0) 617 725 2897