News

Sistemic and leading CDMO, Progenitor Cell Therapy (PCT) initiate study on novel stem cell characterisation technology

2013-03-14T15:09:24Z

Sistemic Limited (Sistemic), the miRNA profiling company with facilities in Glasgow, Scotland and Boston, announced today the signature of an agreement to allow Progenitor Cell Therapy (PCT), Mountain View, CA, and Allendale, NJ, USA, a subsidiary of NeoStem, Inc, New York, to initiate evaluation studies on Sistemic’s SistemQC™ stem cell characterisation technology.

The studies have been designed to allow PCT to evaluate the broad applicability of SistemQC™ technology in stem cell characterisation employing Sistemic’s patented miRNA profiling system and proprietary analytical approaches to produce miRNA panels, termed Key miRNAs or KmiRs™, which PCT may look to employ in the future in process optimisation and cell characterisation.

Jim Reid, Chairman and CEO, Sistemic stated that “PCT is one of the world’s leading contract development and manufacturing organisations (CDMOs) and, in fact, the only CDMO that can count a client with an FDA approved cell therapy (CT) product. It is a great achievement for Sistemic to start working with such a progressive and sector-leading company. We aim to assist PCT in developing a more precise understanding of CT products and thereby help the industry to more rapidly bring effective CT products to market. The CT industry has incredible promise and could be transformational in terms of how we treat a number of diseases that have a huge impact on individuals and healthcare systems alike. In working with PCT we see a clear opportunity to make a significant impact in this vital therapeutic sector.”

Dr. Timothy C. Fong, PCT’s Vice President of Technology and Product Development, added, “We are pleased to work with Sistemic to develop assays to better define our developmental cell therapy products. This technology complements our current efforts and should strengthen our understanding of what cells look like and how they function.”

About Sistemic Ltd

Sistemic’s primary business is focused on providing innovative microRNA-based problem-solving services and kit-based products to areas of unmet need within Pharmaceutical, Biotechnology and the Cell Therapy research, development and manufacture markets. MicroRNAs are seen as the master controllers of a cell and as such Sistemic believe that they are providing instructive information on effects on a whole cell or organism rather than an isolated pathway. This system approach means that the data produced is more indicative of the biology and more diagnostic of actual effect. Their extensive suite of tools for the Cell Therapy community includes SistemQC™ which is used to characterise cells including stem cells (Cell Identity, Purity, Potency, and Safety) as well as monitoring the QC of production. In addition, the drug development markets are served through a range of products which include SistemTOX™, SistemKB™ and SistemRNA™.

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

About Progenitor Cell Therapy

Progenitor Cell Therapy, LLC, (“PCT”) a wholly owned subsidiary of NeoStem, Inc., is a leading CDMO in the cellular therapy industry. Since its inception in 1997, PCT has provided pre-clinical and clinical current Good Manufacturing Practice (“cGMP”) development and manufacturing services to over 100 clients advancing regenerative medicine product candidates through rigorous quality standards all the way through to human testing. PCT has two cGMP, state-of-the art cell therapy research, development, and manufacturing facilities in New Jersey and California, serving the cell therapy community with integrated and regulatory compliant distribution capabilities. Its core competencies in the cellular therapy industry include manufacturing of cell therapy-based products, product and process development, cell and tissue processing, regulatory support, storage, distribution and delivery and consulting services. www.pctcelltherapy.com

Sistemic Poster Winner at World Stem Cell Summit 2012

2013-01-03T12:08:50Z

Dr. David Mallinson, Senior Staff scientist at Sistemic attended the World Stem Cell Summit in West Palm Beach, Florida, on December 3-5th 2012. We are thrilled to announce that David won the Best Poster of the many posters that were presented over the 3 days of the busy international meeting which was judged by a prestigious panel of Cell Therapy Experts. So well done David!

David commented 'The 3 day World Stem Cell Summit was an extremely informative meeting with sessions covering all stem cell topics and with attendance of many of the big players - both from academia and commercial organisations. Being awarded the Best Poster was very exciting and rewarding, and highlights the importance of cell characterisation to the cell therapy field and Sistemic's role as a leader in this area. Thank you to the organisers for awarding Sistemic this prestigious prize. It’s a great way for the team to end a successful 2012.”

David presented Sistemics work on using their novel SistemQC™ methodology to use miRNA-based profiling, analysis & interpretation to sensitively characterise stem cells as well as give a robust read out on quality control [A broadly applicable miRNA-based tool for stem cell characterisation & quality control’]. Sistemic is proud to say that the SistemQC methodology is being widely adopted globally by those that are developing Cell Therapies as well as those developing cell models or disease models for drug screening. For more information about SistemQC and its applications please get in touch at: info@sistemic.co.uk.

EMD Millipore and Sistemic Collaborate to Identify Control Markers for Stem Cell Production

2012-11-01T17:56:43Z

Companies jointly developing kits for quality control of in vitro stem cell cultures
Partnership combines Sistemic's microRNA solutions with EMD Millipore's stem cell expertise
Collaboration to advance stem cell-based therapeutics toward clinical testing

Glasgow, UK, and Billerica, MA, November 1, 2012 / B3C newswire / - EMD Millipore, the Life Science division of Merck KGaA, Darmstadt, Germany, today announced a new initiative with Sistemic Ltd., a leading provider of microRNA-based problem-solving services and kit-based products. The two companies are jointly developing a proprietary monitoring methodology utilizing Sistemic's microRNA marker detection capability to enable consistent growth of stem cells in EMD Millipore's Mobius^® CellReady platform. These markers could also be incorporated into a commercially-available kit for quality control of stem cells in culture.

"To advance the progress of stem cell products toward clinical use, it is critical to ensure the consistency and quality of large-scale culture systems," said Robert Shaw, Commercial Director of EMD Millipore's Stem Cell Initiative. "We are excited to be partnering with Sistemic, as the company's leading microRNA-based solutions will help us continue our efforts toward the commercialization of stem cell processing."

"We are delighted to enter this collaborative arrangement with EMD Millipore," commented Sistemic Chairman and CEO Jim Reid. "The fact that EMD Millipore has chosen Sistemic as its collaborative partner is yet another validation of our ground-breaking research and ability to develop systems for quality control of stem cells, and other mutually beneficial products and programs."

This announcement was made at the Second Annual Stem Cell Meeting on the Mesa, of which Sistemic and EMD Millipore are co-sponsors, October 29-31 in La Jolla, California.

For more information about EMD Millipore's Stem Cell Initiative, please visit:www.emdmillipore.com\stemcells.

Sistemic Announces Customer Agreement with Cytori Therapeutics

2012-06-20T23:10:08Z

Cytori to Utilize Sistemic’s SistemQC™ to Strengthen Understanding of Mechanisms & Support Design of Next-Generation Cell Therapies

Boston, Mass., USA, June 20, 2012 / B3C newswire / – Sistemic Ltd. (“Sistemic”), a leading provider of microRNA-based problem-solving services and kit-based products, has formed a customer relationship with Cytori Therapeutics (“Cytori”). Cytori will utilize Sistemic’s proprietarySistemQC™ technology platform in its U.S. cardiac cell therapy clinical trial to molecularly characterize adipose-derived stem and regenerative cells (ADRCs).

“Research has shown that within adipose tissue, as well as other cell sources like bone marrow, there are multiple distinct cell types that can contribute to efficacy,” commented Sistemic chairman and CEO Jim Reid. “Cytori selecting our SistemQC serves as another validation of our technology, particularly its flexibility to characterize a wide variety of cells for identity and potency, on a molecular level. We could not be more pleased to have reached this agreement with Cytori.”

The announcement was made at the 2012 Bio International Convention in Boston, where Mr. Reid is moderating a panel on stem cell therapeutics featuring leaders from the industry, on Wednesday, June 20, at the Boston Convention Center.

“SistemQC will be incorporated into our clinical development to understand which cell types within our Celution® System’s autologous heterogeneous population of ADRCs are the greatest contributors to efficacy,” said Douglas Arm, Ph.D., Senior Vice President Operations at Cytori. “With Sistemic’s novel technology, we can strengthen the mechanistic understanding of our cell output and at the same time support the design of next-generation cell therapies.”

About Sistemic Ltd
Sistemic’s primary business is focused on providing innovative microRNA-based problem-solving services and kit-based products to areas of unmet need within Pharmaceutical, Biotechnology and the Cell Therapy research, development and manufacture markets. MicroRNAs are seen as the master controllers of a cell and as such Sistemic believe that they are providing instructive information on effects on a whole cell or organism rather than an isolated pathway. This system approach means that the data produced is more indicative of the biology and more diagnostic of actual effect. Their extensive suite of tools for the Cell Therapy community includes SistemQC™ which is used to characterise cells including stem cells (Cell Identity, Purity, Potency, and Safety) as well as monitoring the QC of production. In addition, the drug development markets are served through a range of products which include SistemTOX™, SistemKB™ and SistemRNA™.

About Cytori
Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple "ischemic" conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori's proprietary technologies and products, including the Celution® system product family.

Contact

Dr. Verna McErlane
Director of Commercial Operations
+ 44 (0)7855 376 358
verna.mcerlane@sistemic.co.uk

Sistemic to Moderate Regenerative Medicine Panel at 2012 Bio International Convention

2012-06-19T00:06:18Z

“Stem Cell Therapies… Fact or Fiction” to be Moderated by CEO Jim Reid and Feature C-Suite Executives from California Stem Cell, Tigenix, and Angel Biotechnology

Boston, Mass. – June 18, 2012 – Sistemic Ltd., a leading provider of microRNA-based problem-solving services and kit-based products to the Cell Therapy community, announced today that chairman and CEO Jim Reid is moderating a panel discussion at the 2012 Bio International Convention on Wednesday, June 20, in Boston. Featuring leaders from the regenerative medicine space, the panel is titled “Stem Cell Therapies… Fact or Fiction,” and will share the lessons learned to-date from Scottish, European and American perspectives on the path to successful commercialization of stem cell therapies.

Jim Reid, Sistemic CEO, commented, "Sistemic is very active in the Cell Therapy arena and are members of Alliance for Advanced Therapies (AAT) and the Alliance for Regenerative Medicine (ARM). We see the ability to raise this topic at the leading world event, BIO 2012, as an important step on the path to commercialization of these products which will be transformational in healthcare, and bring hope and cures to many people around the globe."

More information on the panel at BIO 2012:

What: Panel Discussion Featuring Leaders in the Regenerative Medicine Space

When: Wednesday, June 20, 3:00PM EDT

Where: Boston Convention Center, Room 254A

Who: Leaders of the Regenerative Medicine space:

· Jim Reid, Chairman and CEO, Sistemic, UK & USA
· Chief Operating Officer, California Stem Cell, USA
· Eduardo Bravo, CEO, Tigenix, Belgium & Spain
· Stewart White, Commercial Director and acting CEO, Angel Biotechnology Plc, UK

Panel objectives include evaluating lessons learned and best practice including from the Scotland Roadmap for the commercialization of stem cell therapies; identifying global (US and EU) examples of progress in stem cell therapy commercialization; and facilitating a debate on the need for a global, multi-disciplinary approach to successful commercialization of stem cell therapies.

About Sistemic Ltd

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

Contact:

Dr. Verna McErlane

Director of Commercial Operations

+ 44 (0)7855 376 358

verna.mcerlane@sistemic.co.uk

Successful trade mission to Japan and Korea yields new business opportunities for Sistemic

2012-03-26T10:03:55Z

26 March 2012: Sistemic, UK: Sistemic Ltd, Glasgow, concluded a successful trade mission to Japan and Korea in February 2012. Verna McErlane, Director of Commercial Operations, presented the company’s miRNA-based approach to a receptive group of businesses and research institutions in Tokyo, Osaka, Kyoto, Seoul and Jeonju. The Japan portion of the trip was planned by the Scottish and Japanese offices of Scottish Development International (SDI).

During the visit, Sistemic met with both existing and potential clients, and participated in a number of seminars and partnering sessions. Verna McErlane, Director of Commercial Operations, Sistemic, explained: “As the trade mission progressed, it became clear that the partnership model for drug development features highly in the plans of the pharma industry there. It was exciting to have the chance to present how the world’s second largest pharma market will benefit from Sistemic’s unique miRNA profiling products and services.”

Sistemic is pursuing an active global expansion plan for the business. Jim Reid, Sistemic’s CEO commented: “Pharma companies are looking to access technologies on a global basis, so it’s important Sistemic is recognised at this level. We are proud to have customers all over the US and Europe, as well as in Australia and Asia Pacific and we look forward to working closely with a number of new partners in Japan and Korea as a result of the trade mission.”

During the visit, Sistemic presented its SistemQC product for use in cell characterisation and QC. This is of particular interest to anyone working on cell therapies, regenerative medicine and stem cells. SistemQC is a miRNA-based fingerprint approach that provides a powerful and informative way to characterise and monitor cells lines, including stem cells, for identity, purity, safety and differentiation staging. Sistemic also presented details of SistemRNA and how it is used in drug discovery and development. SistemRNA applies a compound-centric approach identifying drug effects by associative changes in miRNA express profiles and its analysis in context. The addition of SistemRNA to the drug discovery toolbox can support strategic decision-making at key stages and maximise asset value.

Verna McErlane added: “The people we met in both countries were very welcoming and interested in innovative tools that can help them in their work. We are following up with a number of companies and planning return visits in June and September.”

For more information about Sistemic and it's products and services, visit: www.sistemic.co.uk

FibromEd and Sistemic are engaged in a collaborative project to identify important micro RNA signatures, required for high fidelity human hepatocyte generation from pluripotent stem cells.

2012-03-20T11:34:01Z

FibromEd and Sistemic (www.sistemic.co.uk) are engaged in a collaborative project to identify important microRNA (miRNA) signatures, required for high fidelity human hepatocyte generation from pluripotent stem cells. The project is funded by the Scottish Stem Cell Network.

Please contact either Dr David Hay (david.hay@fibromed.co.uk) or Dr Verna McErlane (verna.mcerlane@sistemic.co.uk) if you require more details.

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

2012-02-07T15:25:27Z

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

END

Rapid growth continues for Sistemic

2012-01-12T12:44:17Z

"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/

End

Maximise the potential of your stem cell applications

2011-11-29T22:52:16Z

Meet Sistemic experts at Stem Cell Meeting on the MESA

29 November: Sistemic, UK: Dr Verna McErlane, Director of Commercial Operations, International at Sistemic, is scheduled to give her own special insight into advanced analytical models to support the stem cell therapy industry at this year’s Stem Cell Meeting on the MESA conference. Participants will have the opportunity to discuss miRNA profiling and learn how to maximise the potential of stem cell applications. The 2011 conference will be held in the Salk Institute for Biological Studies in La Jolla, California on November 30 and December 1.

Acknowledged experts in cell characterization, Sistemic has recognized a need in the stem cell industry for improved miRNA profiling methodology. The company’s unique approach to miRNA analysis presents significant benefits to stem cell research by providing the tools needed for accurate and rapid cell characterization and an excellent platform for validation prior to commercialization.

Dr Verna McErlane said: “As members of the Alliance for Regenerative Medicine, who are co-organisers of this event, we are particularly delighted to be attending this meeting, which we believe is the premier event for those involved in the stem cell industry.”

Stem Cell Meeting on the MESA is a two-day conference, which is aimed at bringing together the scientific research and business communities. Dr McErlane will be available throughout the two days to discuss your stem cell analysis objectives and how Sistemic can help you meet those objectives more easily. Sistemic looks forward to meeting you there and supporting the event organizers in their goal to facilitate a bridge between academia and industry and further the translation of clinical research.

For further information come along to the meeting or contact Sistemic directly www.sistemic.co.uk