Guildford, UK, 26 March 2013: ReNeuron is pleased to announce that it has received regulatory and ethical approvals to commence a Phase I clinical trial in the UK with its ReN009 stem cell therapy programme targeting the major unmet medical need, critical limb ischaemia (CLI).
CLI represents the second major disease target after stroke for ReNeuron’s lead CTX stem cell line and is based on a number of pre-clinical studies showing dose-dependent positive effects of the CTX cells in restoring microvasculature and blood flow to the limb extremities in animal models of lower limb ischaemia.
The Company’s ReN009 therapy therefore offers the potential for an allogeneic (non-donor specific) and cost-effective cell-based treatment for CLI patients with the aim of restoring sufficient blood flow in the affected lower limb to avoid amputation and the severe health consequences that typically result from such an amputation.
Subject to local R&D site approval, the Phase I clinical trial will be undertaken through NHS Tayside at Ninewells Hospital and Medical School, Dundee, Scotland. The Principal Investigator for the study is Professor Jill Belch FRCP, MD, Institute of Cardiovascular Research, Division of Cardiovascular and Diabetic Medicine at Ninewells. In this dose escalation safety study, the ReN009 cells will be administered via straightforward intramuscular injection into the affected lower limb of nine patients with peripheral arterial disease. Approval may be sought in due course for a further clinical site in Germany to participate in the study.
ReNeuron recently announced that it had been awarded a Late Stage Biomedical Catalyst grant of £0.4 million from the Technology Strategy Board, the UK Government’s innovation agency, to be deployed towards the cost of the approved ReN009 Phase I study.
The Company expects recruitment and dosing of patients in the clinical trial to commence, as planned, in the middle part of this year. The straightforward nature of both the ReN009 treatment and the design of the Phase I clinical trial is expected to lead to progression into a larger placebo-controlled Phase II efficacy study during the second half of 2014, assuming the Phase I primary safety end-point is met.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“These clinical trial approvals for our next major disease target, together with the recently announced Biomedical Catalyst funding for the Phase I critical limb ischaemia study, represent strong endorsements of the strength of ReNeuron’s technologies and its CTX stem cell therapy candidate. They also represent further significant milestones in the Company’s development into a fully-fledged, clinical-stage stem cell therapy business. We are delighted to be working with Professor Jill Belch on this new clinical trial, a well-respected key opinion leader and highly experienced clinician in the limb ischaemia field.”
- ReNeuron +44 (0) 1483 302560
Michael Hunt, Chief Executive Officer
Dr John Sinden, Chief Scientific Officer
- Buchanan +44 (0) 20 7466 5000
Mark Court, Fiona Henson, Sophie Cowles
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Stephen Keys, Adrian Hargrave (NOMAD and Broker)
Andy Roberts (Sales)
About Critical Limb Ischaemia
Critical limb ischaemia is the severe ‘end stage’ manifestation of peripheral arterial disease and is a common side-effect of diabetes. It is caused by chronic lack of blood supply to the leg due to obstruction of blood flow in the peripheral arteries. The condition is characterised by pain at rest and lesions of the leg. There are no effective therapies for the condition and as many as 50% of CLI patients currently have no treatment option other than limb amputation, as surgical re-vascularisation is contra-indicated or ineffective in these patients.
It is estimated that up to four million patients may be affected by CLI in Europe and the US combined, with the addressable patient population representing a potential multi-billion dollar market opportunity globally for a treatment that is able to improve the rate of amputation-free survival in CLI patients.
ReNeuron is a leading, clinical-stage stem cell therapy 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 clinical development. The Company is also developing stem cell therapies for other conditions such as critical limb ischaemia, a serious and common side-effect of diabetes, and blindness-causing diseases of the retina such as retinitis pigmentosa.
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 Merck Millipore.
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.