Guildford, UK, 8 September 2010: ReNeuron Group plc (LSE: RENE.L) gives a trading update ahead of its 2010 Annual General Meeting which will take place today at 10.00am (BST) at the offices of Morrison & Foerster, City Point, One Ropemaker Street, London, EC2Y 9AW.
In the Company’s preliminary results statement on 29 June, we announced that the PISCES (Pilot Investigation of Stem Cells in Stroke) clinical trial with our ReN001 stem cell therapy had received local site approvals in Scotland, enabling the commencement of patient recruitment for the trial. We are pleased to report that the trial has attracted a high level of interest from disabled stroke patients from the local Glasgow community and beyond. As a result, the clinical team, led by Professor Keith Muir, has been able to progress the selection of initial patients meeting the eligibility requirements for the trial. Given the complexities of the PISCES trial and the highly novel nature of the ReN001 therapy, we are greatly encouraged by this progress. Assuming a successful pre-treatment evaluation period once enrolled, we maintain our expectation of initial patient dosing in the PISCES trial towards the end of the year.
Our other therapeutic programmes and business operations are also progressing according to plan. We are continuing our dialogue with regulatory authorities in key territories, including the UK and the US, in respect of our ReN009 stem cell therapy for peripheral arterial disease. Late pre-clinical testing of this therapy is underway, ahead of commencement of clinical development scheduled for early 2012. Our ReN003 programme for retinal diseases, partnered with the Schepens Eye Research Institute at Harvard Medical School in the US, continues to progress well. Following successful cell culture yield optimisation, functional testing of the human retinal progenitor cells (hRPCs) being used in this programme has commenced in appropriate pre-clinical models. Late pre-clinical development of this therapy is scheduled to commence in 2011, ahead of initial clinical testing planned for 2012, focused on patients suffering from the blindness-causing disease, retinitis pigmentosa.
We continue to be encouraged by the progress being made to optimise the manufacture and scale-up of our second-generation frozen cell product, CTXcryoTM. This new formulation of our lead CTX stem cell line has been developed to address the logistical issues typically associated with the distribution and wide-scale clinical use of whole cell-based therapies such as those ReNeuron is taking forward into clinical development.
The Company’s operating costs and cash position remain in line with forecast, with current cash resources (excluding undrawn funding available under our existing equity finance facility with Matrix Corporate Capital) projected to last well into the second quarter of 2011.
Michael Hunt, Chief Executive Officer – ReNeuron +44 (0) 1483 302560
Dr John Sinden, Chief Scientific Officer – ReNeuron
Lisa Baderoon, Mark Court, Isabel Podda
Buchanan Communications +44 (0) 20 7466 5000
Emma Earl, Oliver Rigby
Daniel Stewart & Company plc +44 (0) 20 7776 6550
Alastair Stratton, Tim Graham
Matrix Corporate Capital LLP +44 (0) 20 3206 7000
ReNeuron is a leading, clini cal-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. A ground-breaking first-in-man clinical trial of ReN001 has recently commenced in the UK. ReNeuron’s ReN009 stem cell therapy is being developed as a treatment for peripheral arterial disease, a serious and common side-effect of diabetes. The Company is also developing stem cell therapies for other conditions such as blindness-causing 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.