RENE.L Regulatory News (RENE)

17 Sep 2009 07:00



PRESS RELEASE

2009 AGM trading update

Guildford, UK, 17 September 2009: ReNeuron Group plc (LSE: RENE) today announces a business update ahead of its 2009 Annual General Meeting.

ReN001 stem cell therapy for stroke

In July, the Company announced that the UK Gene Therapy Advisory Committee (GTAC) had issued a final ethical opinion, subject to certain conditions, in favour of ReNeuron's proposed first-in-man clinical trial with ReN001, its stem cell therapy for stroke. GTAC acts as the national research ethics committee for gene therapy and stem cell therapy clinical trials in the UK. This final ethical opinion followed regulatory approval for the clinical trial granted by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) earlier in the year. The ReN001 Phase I trial will take place in Scotland at Glasgow's Southern General Hospital, in patients who have been left disabled by a stroke.

Since the July announcement, the Company has been continuing its interactions with both GTAC and the MHRA to clarify and address the conditions attaching to the favourable ethical opinion. These conditions took the form of amendments to the original clinical trial protocol and the provision of supplemental, non-safety-related pre-clinical data. The Company is pleased to announce that it has now received regulatory approval from the MHRA for the proposed clinical trial protocol amendments. The Company is now working with GTAC to address the remaining points by way of an expedited "real-time" review process outside of the formal GTAC meeting schedule. The Company aims to meet all remaining conditions and complete all remaining pre-trial preparation activities in time to allow commencement of the ReN001 clinical trial in late 2009 or early 2010.

Other developments

The Company continues to make good progress with its ReN009 stem cell therapy for peripheral artery disease (PAD), in collaboration with the UK's Bristol Heart Institute. PAD is a chronic and debilitating disease that progressively restricts blood flow in the limbs, causing cramping, chronic pain and in extreme cases, loss of limb. The disease is commonly associated with other conditions such as diabetes, obesity and stroke.

Following the presentation of initial positive pre-clinical efficacy data from this collaboration earlier in the year, the Company intends to announce further data from its research collaboration with the Bristol team shortly. The Company is engaging a number of pre-clinical and clinical practitioners in the PAD field in the UK, Europe and the US to advise and assist the Company in guiding the ReN009 therapy through to the clinic. The Company will also commence dialogue with the regulatory authorities in these territories shortly, in order to clarify the optimal pathway to the clinic for the ReN009 therapy. Due to the nature of the disease, the type of therapy and the pre-clinical data package that already exists for the CTX stem cell line being used in this indication, the Company expects the remaining pre-clinical and subsequent clinical pathways for ReN009 to be considerably shorter, less challenging and less costly than those for the ReN001 stroke therapy. Subject to further regulatory advice, the Company is targeting the commencement of clinical trials with ReN009 in 2011.

A key factor driving progress with ReN009 has been the Company's recent breakthroughs in the reformulation and manufacturing process for the CTX stem cell line. ReNeuron recently announced a technology transfer and manufacturing contract with Angel Biotechnology plc to generate clinical-grade lots of a second-generation formulation of the CTX cells for subsequent pre-clinical and clinical use in the Company's ReN001 and ReN009 programmes. The practicalities associated with distributing whole cell treatments are a key consideration in the commercialisation of cell-based therapies such as ReNeuron's. This new freeze-thaw formulation makes possible the scale-up and production of CTX cells for wide-scale use across the globe, both clinically and commercially. This scale-up capability should therefore provide the Company with a key advantage when seeking commercial development partners for its therapies.

Sales of ReNeuron's ReNcell® range of cell lines and reagents for non-therapeutic applications continue to increase via the Company's out-licensing agreement with Millipore Corporation. Millipore recently secured its first commercial research sub-license for the ReNcell® products with a leading European pharmaceuticals group. Other major companies and academic researchers continue to show interest in the ReNcell® products, with ReNeuron deriving royalty income from each sale made by Millipore.

Financing 

The Company continues to keep tight control over its costs, with current cash resources projected to last well into the second quarter of 2010. The Company will look to seek further equity-based funding at the appropriate time and is also actively pursuing a number of non-dilutive governmental, regional and charitable translational funding sources, such as the UK Technology Strategy Board's recently announced programme to fund commercial research and development projects in regenerative medicine. 

The Company was pleased to announce the appointment of Daniel Stewart & Company plc as Nominated Adviser and joint broker, and Matrix Corporate Capital LLP as joint broker, to the Company earlier this week. The Company is working with Daniel Stewart and Matrix to further refine its investor relations programme and forward funding strategy.

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 business. Its primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need.

ReNeuron has received regulatory and conditional ethical approvals to commence a Phase I clinical trial in the UK with its lead ReN001 stem cell therapy for disabled stroke patients. The Company is developing stem cell therapies for a number of other conditions, including peripheral arterial disease 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.

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.