Novathera Leads Ambitious £3million DTI Funded project to deliver affordable regenerative medicine therapies

Stem cells are thought to have huge potential as medical treatments in many diseases. However, despite government support progress towards commercialization is slow and the opportunity for developping urgently needed therapies and to take a world-leading position in the emergence of a new pharmaceutical industry could be missed.

Two key factors are slowing things down;
- stem cell biology is still a craft industry, the excellence of UK science is diluted across many separate groups of scientists
- small amounts of funding to each group does not provide the support for ambitious, highly innovative projects that will lead to new medicines and establishing a new industry base.

Novathera (an Imperial College spin out company) has an ambitious plan to help overcome this problem. ‘If stem cell-based therapies are ever to have a significant impact on healthcare, we must abandon the complex, time-consuming and expensive tailor made route. What we needed is an ‘off-the-shelf’ product capable of scale up and turning into cell factories to provide material for medical treatments.’ said Gareth Roberts CEO of Novathera.

This plan draws together world leading groups across the UKcentres to confront the challenges in stem cell biology and produce working sytems for efficient and reliable large scale cell production – using sophisticated bioprocessor technology the group intends to develop the worlds first processes for practical manufacture of cells for medical uses.

• The team at Imperial have already shown the feasibility of automated large scale production of specialised cell types (liver, lung and bone cell factories).
• This technology and the consortium’s expertise provides a huge opportunity to develop a global lead in the industrial and commercial development of regenerative medicine.

The potential therapeutic, social & financial impact of these constructs is enormous;
• The ability to scale up and manufacture large numbers of cells will make cell based medicines easier to develop ad more affordable.
• The cells could be used as model organs so giving a potential alternative to the use of animals in research.
• Initial applications already identified include bone, lung and liver repair.
• The sophisticated technology that will provide a highly standardized means to carry out screening test for enviromental contaminants and bioterrorist weapons.

INFORMATION FOR EDITORS

The project is lead by Novathera based in London (CEO Dr. Gareth W. Roberts) and the partners are Epistem Ltd (Manchester Prof. C. Potten)) and the centres of academic excellence in Imperial College, London (Prof. Dame Julia Polak, Dr. S. Mantalaris, Dr A. Bishop), Cardiff University (Prof. C. Archer), Cambridge University(Profs. R. Pedersen and W. Bonnfield), Southampton University (Prof. R.Oreffo), Manchester University (Prof. Hardingham) and the Roslin Institute in Scotland (Dr. J. McWhir).

Potential Economic Benefits of Clinical Applications – Bone, Liver and Lung

Failures of bone fracture healing results in substantial levels of disability and significant long term healthcare costs to the NHS. Graft procedures for spinal fusions and joint revisions require 6 million cm3 of grafting material and an estimated total costs of >$140 billion.

Liver disease, due to environmental and pathological causes, represents a further significant burden. Despite the success of transplantation, the total annual NHS costs for alcohol-related liver disease alone is £300million.

Lung disease is a particular UK problem, with a death rate twice that of the EU average. As a single example, smoker's lung (COPD) is a significant drain on the NHS, affecting 18% of men & 14% of women 40-68 years and costing £805 million p.a. Globally, 47 million sufferers have been diagnosed but COPD is estimated to affect <600 million people and represents a market valued at $2.8 billion.

Ethical/Regulatory - Consortium members have obtained all the required ethical approvals. A key gain from the project would be the dilution of ethical/regulatory concerns due to success in scale up production which reduces the reliance on primary sources of material.

The research quality in all the academic consortium departments has been rated 5* in the last research assesment exercise.

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NovaThera Ltd. (“NovaThera”) is a spin-out company of Imperial College London. It specializes in pioneering applications of biomaterials and stem cell biology to regenerative medicine and tissue engineering to provide innovative therapeutic solutions. NovaThera has a relationship with Imperial College to continue commercialization of the current and future technologies emanating from Tissue Engineering and Regenerative Medicine Centre (“TERM”) of Imperial College London, a world-class research center combining biology, biomaterials and bio-photonics expertise. For more information about NovaThera please visit www.novathera.com.