Guildford, UK, 11 September 2012: ReNeuron provides a trading update ahead of today’s Annual General Meeting.
Following on from last month’s update, the Company is pleased to report that it has submitted an application to the UK regulatory authority to commence a multi-site Phase II clinical trial to examine the efficacy of its ReN001 stem cell therapy in patients disabled by an ischaemic stroke. The trial is designed to recruit from a well-defined population of patients between two and four months after their stroke, which the Company and its clinical collaborators currently believe will be the optimum treatment window for the therapy.
Following further refinements to its clinical development strategy for ReN001, the Company has filed the Phase II application a number of months ahead of plan. This is to allow sufficient time for the regulatory and ethical review process as the remaining patients are dosed and followed up in the ongoing Phase I PISCES clinical trial with ReN001 over the coming months. The Company also wishes to accommodate the pre-screening of potentially eligible patients for the Phase II study at the sites concerned under a separate non-interventional protocol, currently being finalised. This will enable such patients to be identified in good time while still in acute stroke care at the hospital.
The ongoing PISCES study with ReN001 continues to plan. Following the commencement of treatment of patients in the penultimate dose cohort last month, there remain no cell-related serious adverse events reported in any of the patients treated to date. The independent Data Safety Monitoring Board for the study will shortly make its recommendation regarding treatment of the remaining patients in the penultimate dose cohort. As reported last month, all remaining patients to be treated in the PISCES study have been identified and evaluated as potentially eligible for treatment, with patient enquiries continuing to come into the Glasgow clinical site and a number of patients consequently identified as reserve candidates for the study. On this basis, and subject to regulatory and ethical approvals, the Company hopes to be able to commence the proposed Phase II stroke study in mid-2013.
In June of this year, interim data from the PISCES study from the first five patients treated was presented by the Glasgow clinical team at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan. Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.
The Company is also pleased to report that it has submitted an application to the UK regulatory authority to commence a first clinical trial of its ReN009 stem cell therapy for critical limb ischaemia (CLI). 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 therapeutics 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. These patients also represent the initial target patient population for the Company’s ReN009 therapy, which will be administered via straightforward intramuscular injection of the cells.
The Company and its clinical collaborators plan to conduct an initial 9-patient Phase I dose escalation study with ReN009 in CLI patients, ahead of a larger placebo-controlled Phase II efficacy study, the protocol for which is currently being finalised. The Phase I study will involve at least one site in the UK and a potential further site in mainland Europe (subject to a further clinical trial application in that territory) to ensure swift recruitment and treatment of patients. Subject to regulatory and ethical approvals, the Company hopes to be able to commence the Phase I study in the first half of 2013. The straightforward nature of the treatment and design of the initial ReN009 clinical trial should enable a relatively swift progression into the planned Phase II study, subject to the Phase I safety end-points being met.
In line with its clinical development strategy for both the ReN001 and ReN009 programmes, the Company intends, where appropriate, to conduct Phase II clinical trials with these therapies at sites beyond the UK, including mainland Europe and the US, subject to the requisite regulatory approvals. Discussions with the relevant regulatory authorities are planned over the coming months in this regard, ahead of regulatory submissions in due course.
The Company’s ReN003 programme also continues to progress to plan, targeting the blindness-causing disease, retinitis pigmentosa. A number of pre-clinical studies are planned over the coming year, with a long term pre-clinical safety study due to commence shortly. As previously reported, an initial UK or US clinical trial filing is anticipated in late 2013 in retinitis pigmentosa patients. A protocol for this study is currently in development. The Company will give further updates as the ReN003 pre-clinical development programme progresses.
In line with earlier announcements, the Company remains funded for the next twelve months. Within this time period, the Company will pursue a range of funding options including non-dilutive grants. As reported in the June preliminary results statement, in the longer term, the Company also plans to limit equity funding requirements by the partnering of certain of its stem cell technologies and therapeutic programmes in due course.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“Ahead of today’s Annual General Meeting, it is pleasing to be able to report the achievement of further significant milestones with our ReN001 and ReN009 programmes in stroke and critical limb ischaemia, being the filing of two further clinical trial applications to progress the clinical development of these novel therapies. We continue to make progress across all aspects of our operations in line with plan and we look forward to providing further updates over the coming months.”
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
Cenkos Securities +44 (0) 20 7397 8900
Stephen Keys, Adrian Hargrave (NOMAD and Broker)
Andy Roberts (Sales)
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 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.