Lombard Technologies PLC announces a Collaboration for the Development of a Next Generation Regenerative Stent
London, UK, 2 October 2006 - Lombard Medical Technologies PLC (“Lombard Medical”) today announces that their consortium with Axordia Ltd (“Axordia”) and the University of Sheffield to develop a regenerative stent has received significant funding through the Technology Programme from both the Department of Trade and Industry (DTI) and the Medical Research Council (MRC).
Lombard Medical, Axordia and both the Centre for Stem Cell Biology (CSCB) and the Cardiovascular Research Unit (CVRU) at the University of Sheffield have formed a consortium programme, which Axordia will lead, that will collaborate in a two and a half year project to develop a regenerative stent that will represent a new generation of cardiovascular treatment. The overall programme is forecast to cost £1.8m with the DTI providing funding of £0.4m and the MRC £0.5m. Axordia and Lombard Medical will each contribute products and services to the value of around £0.4m over the project period.
The development of regenerative stent technology is seen as the natural evolution from drug eluting stents (DES) in the treatment of cardiovascular disease and this project will also develop platform technologies with wider application in regenerative medicine. Healthcare industry estimates have suggested that the DES market has reached a value of around $6bn and is still growing rapidly despite some concerns about long-term effectiveness.
Stents are tiny mesh tubes that are used in the treatment of cardiovascular disease, to support the artery wall and keep the vessel open after artery clearing procedures such as angioplasty. However, in over 50% of stenting cases, the patient suffers an inflammatory thickening of the artery, called restenosis. In order to prevent restenosis, drug eluting stents have been developed, which are stents coated in cellular growth inhibiting drugs that elute into the surrounding artery and prevent the thickening of the vessel wall.
Despite the clinical success of drug eluting stents, recent evidence has suggested that they result in higher rates of late stage thrombosis, a clot formation at the end of the stent, which, in over 50% of cases, results in either an acute heart attack or death. Many physicians believe that the clot formations are due to the delayed healing of the vessel caused by the cytotoxic drugs that coat the stent or by some polymers that are used to deliver the drug.
Attaching Axordia’s proprietary, stem cell-derived endovascular cells to Lombard Medical’s PEP™ programmable polymer coating on the stent surface will allow the human body to promote controlled vascular repair and heal the damaged coronary artery vessel wall. The skills provided by the CSCB and CVRU should allow the consortium to move the technology quickly through to clinical trials post the end of the project.
Professor Martin Rothman, St Bartholomew’s Hospital and the London NHS Trust and Non-executive Director of Lombard Medical said:
“Many physicians believe that the success of second-generation drug eluting stents will be measured by how quickly patients can safely come off anti-platelet drug therapy and that late stent thrombosis will no longer be the Achilles heel of DES. It makes sense that encouraging rather than preventing healing is a better route and it seems that regenerative stents could be the answer.”
“We are very pleased to receive the support of the DTI and MRC. Concerns over late-stent thrombosis with existing drug eluting stents have been well publicised in recent weeks, and we believe that this regenerative stent, which accelerates and promotes the healing process in the artery wall, could provide a solution to this problem in the multi-billion dollar DES market.”
Welcoming the new partnership, Science and Innovation Minister, Lord Sainsbury said:
“This initiative provides a real opportunity to harness the world class expertise that we possess in the UK and direct it towards the task of wealth creation. Biotechnology is of crucial importance in our society. By providing a focus for collaboration and delivery, this partnership should establish British industry as the world leader in this area and, an attractive proposition for investors.”
Enquiries:
Lombard Medical Technologies PLC Tel: 01235 750 800
Alistair Taylor, Executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: 020 7831 3113
David Yates / John Gilbert
Notes to editors
About Lombard Medical
Lombard Medical Technologies PLC is a medical devices group developing stent grafts and other medical products for use in the treatment of vascular disease. The Company’s lead product, Aorfix™, is a stent graft for the treatment of aortic aneurysms, a balloon-like enlargement of the aorta which, if untreated, may rupture and cause death. Abdominal and thoracic aortic aneurysms are the 13th largest cause of death in the US and the market is estimated to be worth approximately US$2 billion by 2010. Aorfix™ is currently being commercialised in the EU, with US clinical trials having commenced during 2006. The Company’s Polymer Coatings Division primarily develops polymer coatings for use in drug eluting stents and has a number of research collaborations developing novel products for this $6bn market.
Lombard Medical has recently successfully completed its initial public offering on AIM and was admitted to listing in December 2005, raising £23.9 million, net of expenses. The Company, based in Oxfordshire & Yorkshire, currently employs 90 people.
Further background on the Company can be found at www.lombardmedical.com.
About Axordia
Axordia Limited is one of the UK’s leading stem cell companies. It is using the extraordinary properties of stem cells to improve the speed and safety of conventional pharmaceutical drug discovery and also to develop therapeutic products that exploit the unique properties of its endovascular cells in transplantation and the treatment of cardiovascular disease.
Axordia is based in Sheffield and has strong links to the University of Sheffield, the UK’s leading university in the generation of stem cell intellectual property. The Company is focused on the delivery of three core business streams. Its Drug Discovery products that will provide improved safety and efficacy tests for used in drug development, ESC Tools technologies will improve the research and manufacturing capability of the growing stem cell industry and its Therapeutics research and development programme, which is focused around immune suppression and promoting blood vessel growth.
Further background on the Company can be found at www.axordia.com
About the Centre for Stem Cell Biology
The Centre for Stem Cell Biology (CSCB) has access to the UK’s best stem cell research facilities and world class scientific leadership in Professors Harry Moore and Peter Andrews. The CSCB has a staff of 38 scientists and is a centre of excellence for research on human embryonic stem cells (hESCs) with an international reputation in the field. The Centre has an ongoing programme of generating new stem cell lines and has recently commissioned a facility for creating the cells to Good Manufacturing Practise (GMP) required for cell therapies. Researchers in the Centre have access to over 28 human ES cell lines, including those from Wisconsin, Harvard and Axordia’s. The Centre has obtained £6M in grant funding in the last 3 years from research councils and other national and international agencies for an extensive programme of studies related to fundamental and applied aspects of hESC biology.
For more information please visit www.cscb.sheffield.ac.uk
About the Cardiovascular Research Unit
The Cardiovascular Research Unit (CVRU) within the School of Medicine and Biomedical Sciences at the University of Sheffield has a coordinated programme of research into the pathobiology of blood vessels, in particular the coronary artery. Activity centres on the inflammatory component of the response to injury after balloon angioplasty and stent insertion. The Sheffield CVRU has significant experience of stent devices and is able to provide scientific capacity to investigate pre-clinical efficacy and safety. It also offers, with its partner the Sheffield Teaching Hospitals NHS Foundation Trust and recently established Clinical Research Facility, ready translation of new scientific developments to man. Over the last 3 years, the research programme of the CVRU has been supported by £7M in grant funding from the British Heart Foundation, the Wellcome Trust, the Medical Research Council and other agencies.
For more information please visit www.shef.ac.uk/dcsn/research/cardiovascular/cardio_res
About the Consortium Project
Coronary artery disease causes at least 6.9 million deaths worldwide each year, and is the leading cause of premature death in the UK and Western World. In 2003 the UK spent 17% of its healthcare budget on treating the disease.
During the last ten years, one of the most significant advances in the treatment of cardiovascular disease has been the use of coronary stents. These are tiny metallic mesh like tubes that are inserted to keep arteries propped open after artery-clearing procedures such as angioplasty.
The Achilles heel of stenting has been restenosis (inflammatory thickening of the artery caused by the stent) which occurred in up to 50% of cases often resulting in a costly re-intervention. This dramatically changed with the recent development of drug eluting stents which have virtually eliminated the problem of restenosis. Drug eluting stents (DES) are metallic stents coated with cellular growth inhibiting drugs that elute into the surrounding vessel wall and prevent thickening of the vessel wall. As a result of their clinical success, DES has now become a multi-billion dollar business.
Although DES technology is still in its infancy there appears to be a new and more disturbing problem. Recent evidence suggests that patients who receive DES have higher rates of late stent thrombosis (clot formation at or near the site of the stent) than those treated with bare metal stents. Late stent thrombosis can have disastrous consequences for the patient and in over 50% of cases results in either an acute myocardial infarction (heart attack) or death. Many physicians believe DES related late stent thrombosis is due to the delayed healing of the vessel wall caused by the toxic effects of the drugs or, in some cases, caused by the polymer used to deliver the drug. The longer the healing process takes, the more likely a patient is to have a thrombotic event.
As a result, patients who have a DES procedure are now given anti-clotting (anti-platelet) drugs for up to 12 months, or sometimes longer, to protect against late stent thrombosis. These drugs are expensive and some patients cannot take them for long periods either because of cost or due to complications from bleeding. Physicians are also worried that any interruption to taking these drugs even for a short time could put patients at risk of a thrombotic event. This is particularly true if a patient has to stop anti-platelet therapy to have another surgical procedure, where the risk of sudden thrombosis is extremely high.
This British consortium is embarking upon a two and a half year project to develop a regenerative stent that encourages local vascular repair. Attaching Axordia’s proprietary, stem cell-derived endovascular cells to Lombard Medical’s PEP™ programmable polymer coating on the stent surface will allow the human body to promote controlled vascular repair and heal the damaged coronary artery vessel wall. Stem cell-derived endovascular cells have the remarkable ability to divide and replenish damaged tissue within the artery and will promote rapid healing at the site of stent implantation. They reduce inflammation and create a localised immune privileged site, which acts to prevent rejection.
About the Technology Programme and Strategy
This project is part-funded by a Collaborative R&D grant under the Technology Programme.
The Technology Programme, launched in 2004, is investing directly in new and emerging technologies, and has been designed to help businesses work collaboratively with each other or with academic partners to develop technologies that will underpin products and services of the future. The Technology Programme provides funding using two of the DTI's business support products: Collaborative Research & Development and Knowledge Transfer Networks.
The UK Government's ten-year Science and Innovation Investment Framework, published in July 2004, reaffirmed the commitment to support businesses investing in new and emerging technologies identified by a business-led Technology Strategy Board. Over the period 2005-2008, £370 million is available to businesses in the form of grants to support research and development in the technology area through the Technology Programme.
For further information please go to http://www.dti.gov.uk/innovation/tech-priorities-uk/index.html