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 highlights the need for better cell characterisation in regenerative medicine

03 October 2011: Sistemic, UK:  Sistemic, the cell characterisation problem-solving service provider that uses miRNA, is a strong advocate for the potential of regenerative medicine. Dr Verna McErlane, Sistemic’s Director of Commercial Operations, recently took part in a round-table discussion with leading stem cell researchers http://www.sistemic.co.uk/publications. The scientific, ethical and moral debate about the use of stem cells continues and will soon be taken up in earnest at the World Stem Cell Summit, taking place from 3-5 October in Pasadena, California, where Dr McErlane is a key participant.

 “The future for regenerative medicine is huge, but there are issues to be faced on this road to success,” said Dr McErlane. “Firstly we need to establish reliable cell standards, and secondly these standards should inform the development of a validated and dependable toolbox for monitoring and characterising stem cells during research and manufacturing. Only through characterisation can this technology enter the mainstream clinical practice and provide the patient benefits we are all hoping for.”

 Sistemic has developed a stem cell focused miRNA-based approach called SistemQC™ 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. SistemQC™ 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. Innovative developments such as this, as well as other new tools and a consensus on the standardisation of the process, are that will really drive this industry forward to reach its full potential.

 Dr McErlane went on to say, “Without adequate control, this unique opportunity to positively impact on the treatment of many untreatable conditions will be lost. Standardisation is key and Sistemic are at the forefront of assisting in making Regenerative Medicine a reality for clinical practice.”

 Initiated in 2009, the World Stem Cell Summit (http://www.worldstemcellsummit.com/) has quickly become one of the largest interdisciplinary, networking meetings of stem cell stakeholders, which unites the regenerative medicine industry and biomedical research. For 2011, one of the industry key note addresses, given by Dr Gil Van Bokkelen co-founder and CEO of Athersys and Chairman of the Alliance for Regenerative Medicine, of which Sistemic is a key member , will be; ‘The transformational potential of regenerative medicine, and how it will change healthcare as we know it’.

 Sistemic looks forward to meeting old colleagues, new faces and learning about the most recent developments in the field at the upcoming World Stem Cell Summit. Visitors can meet the team at the Scottish Development International Booth in the exhibit hall. In the meantime, anyone interested in Sistemic and its products should visit: www.sistemic.co.uk

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Cell characterisation experts Sistemic join the Alliance for Regenerative Medicine

08 September 2011: Sistemic, UK: Sistemic Ltd, a fast growing company focused on providing innovative microRNA-based (miRNA) problem-solving services to areas of unmet need within the Cell Therapy/Regenerative Medicine markets and pharmaceutical and biotechnology R&D, is delighted to announce they have joined the Alliance for Regenerative Medicine (ARM). Founded in 2009, the Alliance has more than 80 members, who span research institutes, foundations, companies and investor groups. Their aim is to advance regenerative medicine by representing and supporting members in front of government agencies and the general public.

Sistemic is committed to the regenerative medicine sector and believe ARM has a key role in this exciting area. Support from Sistemic will include access to their cell characterization knowledge, innovative tools and experience for ARM members and also the broader community. Sistemic is confident that their miRNA profiling technology will make a significant contribution to the advancement of cell and regenerative therapies as well as to those developing stem cell lines for drug discovery and development.

Verna McErlane, Director of Commercial Operations, International at Sistemic Ltd, comments: “The revolution promised by cell-based techniques and therapies that regenerate cells, organs and tissues is a key area where Sistemic is making a contribution. Our customers are looking for tools to help them overcome the challenges of commercialisation of cell-based or derived products – namely, the absence of robust and information-rich characterisation and QC methods to monitor cells easily and effectively. Sistemic’s core expertise, the SistemQC^TM product, reduces these hurdles, providing an approach that fits seamlessly within their current workflow.”

SistemQC^TM combines robust miRNA profiling with superior statistical analytics and multi-layered contextual analysis to generate a fingerprint of key miRNAs (kmiRs) providing 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. These kmiR fingerprints can be adapted to a QPCR method for ease of integration into laboratory routine, and provide rapid testing. The result? Global understanding of cell systems allowing informed decision making for companies, at critical points within their process workflows, allowing them to proceed confidently with their cell populations.

Morrie Ruffin, Managing Director of ARM, said: “We are delighted that Sistemic have joined ARM and look forward to sharing information and understanding as we work together towards advancing the field of regenerative medicine… we feel Sistemic has a great deal to offer the Alliance in helping to support and develop this sector .”

For more information about Sistemic products and services, visit: www.sistemic.com

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For press information, please contact:    

Sarah Lawton, Kapler Communications                      

Knowledge Centre, Wyboston Lakes, Great North Road,

Wyboston, Bedfordshire, MK44 3BY, UK

Tel: +44 (0)1480 479280; Fax: +44 (0)1480 470343 sarah@kapleronline.com

 Sistemic UK Ltd.

Thomson Building, Gilmorehill, Glasgow, UK, G12 8QQ

Tel: +44 (0) 141 330 1683 Fax: +44 (0) 141 330 2062 verna.mcerlane@sistemic.co.uk

 Sistemic US Ltd.

28 State Street, Suite 2300, Boston, USA, MA 02109

Tel: +1 (0) 617 523 3272 Fax: +1 (0) 617 725 2897 info@sistemic.co.uk

 Contact:

Dr Verna McErlane, Director of Commercial Operations, International, +44 7855376358