Guildford, UK, 17 November 2010: ReNeuron Group plc (LSE: RENE.L) today provides an update on progress with its ReN009 stem cell therapy for peripheral arterial disease (PAD). 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.
Pre-clinical efficacy testing of the ReN009 therapy has been conducted in collaboration with Professor Paolo Madeddu, Dr Rajesh Katare and colleagues at the Bristol Heart Institute, University of Bristol, UK. Dr Katare is today presenting positive pre-clinical efficacy data with ReN009 at the prestigious American Heart Association Scientific Sessions 2010 in Chicago, running from 13-17 November. In the study to be presented, which follows on from a series of successful earlier pre-clinical efficacy studies undertaken by the Bristol team, ReNeuron’s lead CTX stem cell line was tested in a recognised diabetic mouse model of hind limb ischaemia. 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, when treated with the CTX cells.
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.
In conjunction with its Clinical Advisory Board for ReN009 and its other clinical and regulatory advisers, the Company has established the late pre-clinical development pathway for the ReN009 programme, leading to a proposed multi-centre first-in-man clinical trial planned for early 2012. The Company has commenced interactions with, and received guidance from, regulatory authorities in both the UK and the US. The rate-limiting, long-term pre-clinical safety studies required are well underway and will run alongside the remaining pre-clinical studies and cell manufacturing campaign necessary to complete the regulatory data package to be submitted for clinical trial approvals in due course.
The Company will provide further progress updates regarding the ReN009 programme at appropriate points in time over the coming year.
Michael Hunt, Chief Executive Officer – ReNeuron +44 (0) 1483 302560
Dr John Sinden, Chief Scientific Officer – ReNeuron
Mark Court, Isabel Podda
Buchanan Communications +44 (0) 20 7466 5000
Emma Earl, Oliver Rigby
Daniel Stewart & Company plc +44 (0) 20 7776 6550
Alastair Stratton, Tim Graham
Matrix Corporate Capital LLP +44 (0) 20 3206 7000
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 Bri stol 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, clinical-stage stem cell business. Its primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.
ReNeuron has used its unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered “off-the-shelf” to any eligible patient without the need for additional immunosuppressive drug treatments. ReNeuron’s lead candidate is its ReN001 stem cell therapy for the treatment of patients left disabled by the effects of a stroke. This therapy is currently in early clinical development. ReNeuron’s ReN009 stem cell therapy is being developed as a treatment for peripheral arterial disease, a serious and common side-effect of diabetes. The Company is also developing stem cell therapies for other conditions such as blindness-causing 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 s tatements 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.