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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Rapid growth continues for Sistemic

"ON TOP OF THE WORLD"

12 January 2012: Sistemic, UK:  Sistemic, the stem cell and drug development technology company, has won a substantial Scottish Regional Selective Assistance (RSA) grant from Scottish Enterprise. The grant forms part of a £1M planned investment programme which, on the back of a very successful year for the company, will see Sistemic more than double the size of its operation. To accommodate the expanded  research team, the company is relocating to customised laboratories during the first half of 2012.

Jim Reid, Sistemic ‘s Chairman and CEO said, “Securing this support from Scottish Enterprise is a major achievement and shows great support by the Scottish Government for what we are doing. It adds to an already successful year for Sistemic, a year which has seen us grow sales dramatically and develop our customer base in Europe, USA, Japan and Australia. We truly have become a global company during 2011 and we look forward to relocating in the first half of 2012 to allow this success and growth to continue. It is always an exciting opportunity to be on the lookout for new employees and we are ideally placed to recruit top talent. This type of grant support is crucial to help grow successful research focused biotech companies such as ours and we will ensure we make the most of it!”

“We work very closely with some of the world’s leading stem cell and pharmaceutical companies and we need to continually review our operations to make sure that we have the best technology and services and we need a facility which suits our needs,” explains Reid. “The world is waking-up to the incredible opportunities offered by stem cell technology. Opportunities which show great promise to prolong healthy life and Sistemic is already a key part of this burgeoning worldwide industry.”

Sistemic‘s SistemRNA™, SistemQC™, SistemKB™  and SistemTOX™ products have brought new depth to miRNA analysis, which has been shown to add value to drug discovery, cell therapeutics and diagnostics.  For 2012 the company looks forward to increased business and growing their client network around the world.

For further information on Sistemic and Sistemic miRNA analysis products, please visit: www.sistemic.co.uk

Regional Selective Assistance (RSA) is the main investment grant scheme in areas of Scotland designated for regional aid under European Community law. RSA funding is available to create or safeguard jobs for both Scottish owned businesses and inward investors. For further information visit the Scottish Development International website: http://www.sdi.co.uk/

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Sistemic presents the solution for broader stem cell therapy at AUSBiotech 2011

18 October : Sistemic, UK:  Verna McErlane, Director of Commercial Operations for miRNA specialist Sistemic, is attending AUSBiotech 2011 in Adelaide, South Australia, 16-19 October. At this event she presented a talk entitled ‘The Challenges of Advancing Stem Cell Therapies into the clinic; a Characterisation Perspective’. The presentation formed part of the ‘Human Health – Clever cell culture for the innovation of biologics’ session on 18 October.

Dr McErlane’s talk provided an intuitive overview of the cell therapy market including future promise, what has been achieved to date, followed by a review of some of the challenges in bringing a cell therapy to the clinic. She then focused on cell characterisation and the utility of using miRNA fingerprinting by showcasing recent case studies where Sistemic SistemQC technology has provided unique insight to assist stem cell developers produce better and more standardised cells.

“The stem cell sector has already shown its promise in producing effective treatments but these are just the tip of the iceberg and there is the potential for so much more,” said Dr McErlane. “The cell therapy industry is at a critical cross-roads during its evolution into the clinical environment and there are some real challenges ahead including a definite need for reliable standardisation and characterisation methodology.”

Jim Reid, CEO of Sistemic commented, “At Sistemic we are addressing key challenges and, in conjunction with our stem cell clients, coming up with practical solutions which will enhance the potential of these developments in safe and effective patient treatment.”

The translation of stem cell technology from the lab into the clinic requires reliable monitoring and characterisation methodology. Sistemics’ SistemRNA and SistemQC use a stem cell focused, miRNA-based approach which molecularly characterises cells and monitors their quality. Not only does it give a succinct read out on the status of the cells, but also provides an insight into the underlying biological effects associated with any change observed. This is being used by the stem cell community to optimise and guide the differentiation process, benchmark differentiated cells and, from a manufacturing perspective, provide identity markers, purity and potency control. Such innovative developments, together with other new tools and a consensus on the stardardisation process, are what will really drive this industry forward to reach its full potential.

 Sistemic looks forward to meeting old colleagues, new faces and learning about the most recent developments in the field at AUSBiotech 2011 . Visitors can meet the team at the Scottish Development International booth in the exhibition hall. In the meantime, anyone interested in Sistemic and its products should visit: www.sistemic.co.uk

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