Sistemic to Work with TiGenix On Landmark EUR 5.9 Million, FP7 European Project Aiming at Developing an Innovative Rheumatoid Arthritis Cell Therapy Treatment Product

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

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Sistemic expands SistemQC™ microRNA-based services into stem cell QC

                                                                PRESS RELEASE

Glasgow, Scotland, October 4^th, 2010 – Today Sistemic Ltd launched the expansion of its patented SistemQC™ services into quality control of stem cells at the World Stem Cell Summit in Detroit. SistemQC™ could hold part of the jigsaw puzzle to successful development of the stem cell therapeutic market. This exciting and rapidly progressing new field is predicted to grow by 29% annually to reach more than $1.7 billion by 2015.

SistemQC™’s microRNA-based fingerprint of the stem cell system has clear applications in cell characterisation and the production process. It can be used to easily and efficiently monitor stem cell identity, drift, differentiation staging and purity. According to CEO Prof. Chris Hillier, SistemQC™ has been launched in response to widespread demand: “As stem cell therapies increasingly enter the clinic and potentially market, there is a huge unmet need for reliable, information-rich QC methods to monitor cells easily and effectively and to fit within current workflow processes. Importantly, SistemQC™ not only gives a succinct read out on the status of the cells but also an insight into the underlying biological effects associated with any change detected. We have already had a great deal of interest from both research institutions and biopharma and hope to sign our first contracts by the end of 2010”.

The launch of SistemQC™ services for stem cells adds another arm to Sistemic’s portfolio of microRNA-based innovative services which also include drug discovery and development tools as well as a drug repositioning engine.

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About SistemRNAÔ - SistemRNA™ is an enabling platform technology which profiles microRNA expression and utilises in-house customised algorithms which analyse the miRNA dataset that is produced when a cell is perturbed by a stimulus. This creates models/clusters of microRNA that define the phenotypic response. The microRNA response is reproducible and is a robust marker defining the biological interaction between cell and the environment. The benefit is that microRNA profiling monitors pathway control of the entire biological system of the cell in a single assay. Data is kept to a minimum where as knowledge is greatly enhanced allowing more appropriate decisions to be taken. SistemRNA™ analysis captures the dynamic response of all the cellular pathways as well as their interactions giving enhanced clarity without data overload.

About Sistemic Ltd – At the core of Sistemic lays a deep understanding of microRNA biology and profiling which in combination with customised in-house data analysis, and contextualisation programs provides a powerful tool to simplify the understanding of the biology. Sistemic’s primary business is focussed on providing innovative, problem solving services and kit based products to the life sciences research and development markets. 

For more information please contact,

Prof. Chris Hillier, CEO

Phone: +44 (0) 7908 154979                Email: chris.hillier@sistemic.co.uk 

Dr. Verna McErlane, Director of Commercial Operations

Phone: +44 (0) 7855 376358               Email: verna.mcerlane@sistemic.co.uk

More information about Sistemic is available at http://www.sistemic.co.uk