Guildford, UK, 17 October 2012: ReNeuron provides an update on progress with the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients.
In this open label, dose-ranging Phase I safety study, taking place in Scotland, ReNeuron’s ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.
The Company is pleased to report that the third and penultimate dose cohort of three patients have all now been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising. This follows approval given last month by the independent Data Safety Monitoring Board (DSMB) for the study to proceed to completion of dosing of this patient cohort.
The PISCES study continues to run to plan, with no cell-related serious adverse events reported in any of the patients treated to date. As previously reported, the remaining three, high-dose cohort 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. Subject to DSMB approval, these final three patients are scheduled to be treated in January and March 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 10(th) 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.
Based on the above progress, the Company announced last month that, ahead of plan, it had submitted an application to the UK regulatory authority to commence a multi-site Phase II clinical trial to examine the efficacy of ReN001 in patients disabled by an ischaemic stroke. This 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. Subject to continuing positive progress with the PISCES study, and subject to regulatory and ethical approvals, the Company hopes to be able to commence the Phase II stroke study in mid-2013. The proposed study is expected to take up to 18 months to complete.
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(R) products for use in academic and commercial research. The Company’s ReNcell(R) CX and ReNcell(R) 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.