Guildford, UK, 27 March 2013: ReNeuron provides an update on progress with its ReN001 stem cell therapy for disabled stroke patients.
Following a further positive assessment from the independent Data Safety Monitoring Board (DSMB) for the study earlier this month, the final dose cohort in the ongoing PISCES Phase I clinical trial with ReN001 has now been treated and the final patient dosed in the study has been discharged from hospital. No cell or immune-related adverse events have been reported in any of the patients treated to date. Last year, interim data from the first five patients treated in the PISCES study were presented by the clinical site team, with sustained reductions in neurological impairment and spasticity observed in all five patients compared with their stable pre-treatment baseline performance. Further and longer term data from the study will be presented at a scientific conference later this year.
As previously announced, the Company has 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.
The Company is pleased to report that it has now cleared all points arising from the regulatory review of the Phase II application, assuming a continuing positive safety read-out from the ongoing PISCES study in the short term. The regulatory authority has also agreed with the Company’s proposal to curtail recruitment into the PISCES study at eleven patients rather than the twelve originally planned, with a consequent additional short-term safety assessment to be added for the first patient treated in the Phase II study. This change is in response to the Company’s contract cell manufacturer for the PISCES study recently entering into administration. Prior to this, the Company had contracted CTX cell supply for future clinical studies in both stroke and critical limb ischaemia with an additional contract manufacturer and is currently in the process of validating a third supplier.
In line with plan, the Company will therefore seek final regulatory and ethical approvals for the Phase II study by submitting a data package including three month follow-up data on the final dose cohort in the PISCES study to the regulatory authority in early July and, assuming approvals are granted, expects to commence recruitment into the Phase II study shortly thereafter.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“We are delighted to have achieved another significant milestone in the development of our ReN001 stem cell therapy for stroke, namely the completion of dosing in the pioneering PISCES clinical trial. At least ten clinical sites around the UK have expressed their desire and ability to participate in the proposed Phase II study and, subject to remaining approvals, we look forward to commencing this study, as planned, later this year.”
- 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.