Guildford, UK, 16 November 2009: ReNeuron Group plc (LSE: RENE.L) announces further positive pre-clinical efficacy data 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, loss of limb. PAD is commonly associated with other conditions such as 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 by Professor Paolo Madeddu, Chair of Experimental Cardiovascular Medicine and colleagues at the Bristol Heart Institute, University of Bristol, UK, and builds on earlier preliminary work conducted by that group. In two studies, the researchers tested ReNeuron’s lead CTX neural stem cell line, via intramuscular injection, in a recognised murine hind limb ischaemia model. A range of doses were used across the studies, from 3,000 to 3 million cells per treatment. A significant and dose-dependant recovery of blood flow to the ischaemic limb was seen as soon as three days after ischaemia, with significantly increased revascularisation of the damaged tissue after 21 days, as measured by increased capillary and arteriole density.
The results of the above studies were presented by poster at the American Heart Association Scientific Sessions 2009 in Orlando, Florida, running from 14-18 November. An AHA Scientific Council travel stipend has been awarded to the Bristol team poster presenter in recognition of the scientific excellence of the abstract submitted to the Scientific Sessions.
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. Further pre-clinical studies are currently in progress with ReN009, focusing on diabetic models and utilising the newly-developed frozen formulation of the CTX cell line which will be used in future clinical trials. The results of these further studies will be reported in early 2010. In the meantime, ReNeuron has scheduled meetings within the next month with both the UK Medicines and Healthcare Regulatory Agency (MHRA) and the UK Gene Therapy Advisory Committee (GTAC) in order to discuss and agree certain aspects of the late pre-clinical development plan for the ReN009 therapy. Equivalent meetings are also planned with regulatory authorities in other territories, including the US, ahead of initial clinical trials expected to commence in 2011.
Commenting on the results of the study, Professor Madeddu said:
“We are excited by these latest results using the CTX stem cell line, where we have successfully replicated, in a dose-dependent way, the results of a promising initial study in a recognised hind limb ischaemia model. We see real clinical potential in this cell line in ischaemia, 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:
“The data from these studies clearly demonstrate the potency of our lead CTX stem cell line in models of ischaemia. With the ReN009 therapy, we aim to translate this potential towards a clinical setting in diabetic patients with critical limb ischaemia as a key objective for ReNeuron over the coming months. In order to achieve this, we will be greatly assisted by the very significant data package regarding safety and product quality that already exists for the CTX cell line, generated during the pre-clinical development of our ReN001 therapy for disabled stroke patients.”
Michael Hunt, Chief Executive Officer
Dr John Sinden, Chief Scienti fic Officer
ReNeuron Group plc +44 (0) 1483 302560
Jonathan Birt, Susan Quigley
Financial Dynamics +44 (0) 20 7831 3113
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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 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 received regulatory and conditional ethical approvals to commence a Phase I clinical trial in the UK with its lead ReN001 stem cell therapy for disabled stroke patients. The Company is 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.