Guildford, UK, 3 March 2010: ReNeuron Group plc (LSE: RENE.L) today announces further positive pre-clinical efficacy data with its ReN009 stem cell therapy for peripheral arterial disease (PAD) in diabetic patients. PAD is a chronic and debilitating disease that progressively restricts blood flow in the limbs, causing cramping, chronic pain and in extreme cases, amputation. PAD is commonly associated with other conditions, including diabetes, obesity and stroke. At least 1 in 20 people over the age of 55 have some degree of PAD and it becomes more common with increasing age.
The research was conducted in collaboration with Professor Paolo Madeddu, Dr Rajesh Katare and colleagues at the Bristol Heart Institute, University of Bristol, UK, and builds on earlier successful pre-clinical efficacy studies with ReN009 conducted by that group. In this latest study, researchers tested the newly-developed freeze-thaw formulation of ReNeuron’s CTX stem cell line, via intramuscular injection, in a recognised diabetic mouse model of hind limb ischaemia. The CTX cell line forms the basis of ReNeuron’s ReN009 therapy for PAD as well as its ReN001 therapy for stroke. Initial clinical trials with ReN001 are due to commence in the UK shortly, following final regulatory approval received last month.
The results of the new ReN009 study initially showed that the diabetic mice had reduced blood flow capacity compared to the non-diabetic control mice. When treated with the ReN009 cells, the diabetic mice exhibited a significant and dose-dependent recovery of blood flow to the ischaemic limb, with significantly increased re-vascularisation of the damaged tissue as measured by increased capillary and arteriole density. These results are being presented by poster at the Diabetes UK Annual Professional Conference in Liverpool, UK, running from 3-5 March. Further details of this conference may be found at www.diabetes.org.uk/apc.
ReNeuron is developing its ReN009 therapy as an allogeneic (non-patient specific) stem cell treatment for late-stage PAD, or critical limb ischaemia, in diabetic patients for whom PAD is a side-effect of their diabetes. PAD in diabetics is severe and progresses rapidly. Vascular surgery often has a poor outcome in these patients and in severe cases, amputation is the only clinical option available. ReNeuron’s ReN009 therapy offers the potential to re-build the vasculature in the affected limb, thus restoring blood flow and avoiding the need for amputation in diabetic patients with critical limb ischaemia.
ReNeuron has discussed its late pre-clinical development plan for ReN009 with the UK regulatory authorities. The Company will work with its newly-established Clinical Advisory Board for ReN009 and will take further meetings with UK, European and US regulators over the course of this year, ahead of applications to commence initial clinical trials planned for next year.
Commenting on the results of the study, Professor Madeddu said:
“In this latest study, it is clear that ReNeuron’s CTX stem cells significantly improved clinically relevant aspects of hind limb ischaemia in a diabetic mouse model in a dose-dependent manner. Taken together with the earlier studies we have performed with this cell line, we see real clinical potential in this cell line in ischaemic conditions such as peripheral arterial disease, where the angiogenic properties of the cell line appear to play a significant role in restoring blood flow in the affected region.”
Dr John Sinden, Chief Scientific Officer of ReNeuron, said:
“We are very excited to have made this important pre-clinical breakthrough in demonstrating the clear potential of our CTX stem cell line to alleviate and even reverse the effects of lower limb ischaemia in diabetics. With our ReN009 therapy, which utilises our recently-developed freeze-thaw formulation of th e CTX cell line, we are now well-placed to take a leading position in the development of a fully scalable, storable and readily administered cell-based therapeutic for diabetics suffering from peripheral arterial disease, a condition poorly served by existing treatments. We look forward to reporting further progress with ReN009 as we move towards clinical trial applications next year.”
Michael Hunt, Chief Executive Officer
Dr John Sinden, Chief Scientific Officer
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About the Bristol Heart Institute and the University of Bristol
The Bristol Heart Institute is made up of over 200 researchers and clinicians, from eight different departments in the University of Bristol, spanning three faculties, and from associated Bristol NHS Trusts. Research income is generated from grants, with the British Heart Foundation being the Institute’s main funder.
As well as improving collaboration between scientists and clinicians within the Institute, the aim is to communicate research findings to the public.
Further information on research at the Bristol Heart Institute can be found at www.bris.ac.uk/bhi.
The University of Bristol is consistently ranked among the leaders in UK higher education. According to The Times, it is among the top 40 universities in the world. Research-intensive and with an international reputation for quality and innovation, the University has 15,000 students from over 100 countries, together with more than 5,500 staff. In terms of the number of applications per undergraduate place, Bristol is arguably the most popular university in the country.
The University was founded in 1876 and was granted its Royal Charter in 1909. It was the first university in England to admit women on the same basis as men. It is located in the heart of the city from which it grew, but is now a significant player on the world stage as well as a major force in the economic, social and cultural life of Bristol and South West England.
The overall quality of the University’s teaching emerged as ‘excellent’ from the rigorous, independent assessment process. Its record as a research institution is at least as distinguished, with 78 per cent of its departments judged as world class or internationally excellent. The University is also recognised as a leading centre for the exploitation of knowledge through partnership with industry and the creation of spinout companies.
Bristol is a member of the Worldwide Universities Network and of the Russell Group of major, research-intensive universities in the UK.
ReNeuron is a leading, UK-based stem cell business. Its primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need.
ReNeuron has regulatory approval for a Phase I clinical trial in the UK with its lead ReN001 stem cell therapy for disabled stroke patients. Patient recruitment for this trial will commence shortly. The Company is also developing stem cell therapies for a number of other conditions, including peripheral arterial disease and diseases of the retina.
ReNeuron has also developed a range of stem cell lines for non-therapeutic applications – its ReNcell® products for use in academic and commercial research. The Company’s ReNcell®CX and ReNcell®VM neural cell lines are marketed worldwide under license by USA-based Millipore Corporation.
ReNeuron’s shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found at www.reneuron.com.
This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as “should”, “expects”, “estimates”, “believes” or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect ReNeuron’s current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause ReNeuron’s actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements.