Regulatory update

RNS Number : 3019F

ReNeuron Group plc

11 January 2010

 



PRESS RELEASE

Regulatory update

Guildford, UK, 11 January 2010: ReNeuron Group plc (LSE: RENE.L) today provides a regulatory update regarding its ReN001 stem cell therapy for stroke and its ReN009 stem cell therapy for peripheral arterial disease (PAD).

ReN001

In December, the Company finalised and submitted the supplemental pre-clinical data package requested by the UK Gene Therapy Advisory Committee (GTAC) in support of the Company's proposed Phase I clinical trial with ReN001. This data package was submitted to GTAC in response to a condition attaching to GTAC's final favourable ethical opinion already given with regard to the proposed clinical trial. The package contains data from further pre-clinical studies demonstrating the positive functional effects of the ReN001 cells and the mechanisms by which the cells engender these positive effects in relevant disease models. The results of these studies consequently impact favourably on the risk-benefit profile of the ReN001 therapy by providing further evidence of the potential clinical benefits that the therapy may bring to disabled stroke patients. 

These new pre-clinical studies with ReN001 were conducted over recent months by leading academic researchers in the field and the key data from the studies will be submitted for presentation and publication in due course.  

Assuming a swift and successful review process resulting from this submission, the Company maintains its target of commencing the ReN001 Phase I clinical trial in the UK in the first quarter of this year.

ReN009

The company has made further advances with its ReN009 programme for PAD. Following the presentation of positive pre-clinical efficacy data with ReN009 at the recent American Heart Association meeting, the Company has taken scientific advice meetings with both GTAC and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in order to discuss and agree certain aspects of the late pre-clinical development plan for this therapy. The Company is encouraged by the feedback it has now received from both of these meetings, with no substantive or unforeseen issues raised based on the data provided to these regulatory bodies.  

The Company is now proceeding with late pre-clinical testing of the ReN009 therapy and will continue to liaise with the regulatory authorities both in the UK and in other territories, including the US, ahead of the commencement of initial clinical trials next year.

Enquiries:

Michael Hunt, Chief Executive Officer Dr John Sinden, Chief Scientific Officer ReNeuron Group plc	[phone]
Jonathan Birt, Susan Quigley Financial Dynamics	[phone]
Simon Leathers, Emma Earl  Daniel Stewart & Company plc	[phone]
Alastair Stratton, Tim Graham  Matrix Corporate Capital LLP	[phone]

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.

 

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