RENE.L Regulatory News (RENE)

19 Sep 2008 07:00



AGM Statement

Guildford, UK, 19 September 2008: ReNeuron Group plc (LSE: RENE) today announces a business update ahead of its 2008 Annual General Meeting.

ReN001 stem cell therapy for stroke

In June 2008, the Company stated in its preliminary full year results statement that it was undertaking further studies in support of its application to commence initial clinical trials with ReN001 in the USA, and that the Company intended to make further clinical trial applications beyond the US for ReN001 during the remainder of the year.

The Company has since submitted an application to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to commence a Phase I dose-ranging clinical study for ReN001 in the UK. An application to commence a similar study in Australia will be submitted to the Australian regulatory authorities shortly. The regulatory review response times will depend on the differing review processes the respective regulatory authorities wish to adopt for an advanced therapy application of this nature. The Company will make further announcements regarding the outcome of the applications in due course. In the meantime, the Company is continuing studies in support of its US clinical trial application for ReN001 and intends to continue its dialogue with the FDA in this regard.

Other developments

In the June 2008 results statement, the Company also stated its intention to accelerate pre-clinical development timelines in its programmes by testing the potential of its lead CTX cortical cell line in other conditions beyond stroke, as well as developing enhanced methods of administration for its ReN001 stroke therapy in broader stroke patient populations.

The Company has since commenced a UK-based research collaboration with Professor Paolo Madeddu, Chair of Experimental Cardiovascular Medicine at the Bristol Heart Institute. Following an encouraging feasibility study, the collaboration will test the CTX cell line in a pre-clinical model of peripheral lower limb ischaemia, a debilitating condition affecting up to 12 per cent of the adult population, in which reduced blood supply to the limbs causes cramping, chronic pain and in extreme cases, loss of limb.

Based again on successful pilot studies conducted in the US, the Company intends shortly to extend its collaborative research programme to develop an intravenously-administered therapy for stroke patients in the sub-acute phase, building on ReNeuron's existing ReN001 programme focused on long-term disabled stroke patients.

Since the June results statement, the Company has published positive pre-clinical efficacy data regarding its ReN004 programme for Parkinson's disease in the journal, Stem Cells and Development (Miljan E. et al. SCD-2008-0078). The paper, published on-line ahead of print, describes how two of ReNeuron's candidate neural cell lines isolated from mesencephalic tissue produced sustained improvements in behavioral outcomes compared to non-cell control groups over the course of six months in a rodent model of Parkinson's disease.

The Company has also recently received confirmation from the US Patent and Trademark Office that three further US patent applications covering ReNeuron's platform technologies and cell lines have been granted. Patent No. 7371374 covers the expansion of neural stem cells to treat disease using the Company's c-mycER cell expansion platform or related technologies. Patent Nos. 7416888 and 7419827 relate to the composition of two of the Company's key human neural stem cell lines, including the lead CTX cortical cell line used in the Company's ReN001 therapy for stroke. Equivalent patents have already issued in Europe, and bring the total number of issued patents written or exclusively licensed by ReNeuron to over 80, of which over 50 have issued in the key European and US territories.

Funding

In June 2008, the Company announced that it had initiated steps to significantly reduce headcount and overheads, focusing resources primarily on programmes with the fastest routes to clinic or those capable of being funded via grants and/or other collaborative arrangements.

The Company has since completed its initial cost-reduction programme, including the closure of its US laboratory facility, with no material restructuring costs arising. ReNeuron now employs 15 full-time equivalents from its Surrey laboratories. The Company is, however, continuing to look at ways to take further cost out of the organisation, including, where necessary, the suspension of further programmes which do not meet the above criteria.

As a result of the above measures, the Company expects its current financial resources to last well into the first half of 2009 and its projected financial requirements thereafter have been significantly reduced. The Company therefore remains confident of securing sufficient further financing based on anticipated progress with its ReN001 and other programmes over the coming months.

The AGM will take place today at 10.00am at the offices of Morrison & Foerster, City Point, One Ropemaker Street, London, EC2Y 9AW.

Enquiries:

About ReNeuron

ReNeuron is a leading, UK-based stem cell company. Its primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need.

ReNeuron has filed for approval to commence initial clinical studies with its lead ReN001 stem cell therapy for disabled stroke patients in both the USA and the UK. There are an estimated 50 million stroke survivors worldwide, approximately one half of which are left with permanent disabilities. The annual health and social costs of caring for these patients is estimated to be in excess of £5 billion in the UK and in excess of US$50 billion in the USA. In addition to its stroke programme, ReNeuron is developing stem cell therapies for a number of other conditions, including peripheral ischaemia, Type 1 diabetes and 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.

Data sources: UK Stroke Association; American Stroke Association.

The terms 'ReNeuron', 'the Company' or 'the Group' used in this statement refer to ReNeuron Group plc and/or its subsidiary undertakings, depending on the context.

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.