Data confirms pre-clinical efficacy of ReN001

RNS Number : 8410U

ReNeuron Group plc

03 January 2012

 



                            

     

      PRESS RELEASE

Newly published data confirming pre-clinical efficacy of ReNeuron's ReN001 stem cell line for stroke

Data show up to 83% recovery of motor function in rat model of stroke

Guildford, UK, 3 January 2012: ReNeuron Group plc (LSE: RENE.L) ("ReNeuron" or "the Company") announces that positive data from a pivotal pre-clinical study using its lead CTX neural stem cell line in a stroke model has been published on line in the leading journal Stem Cells¹. An abstract can be viewed at:

http://onlinelibrary.wiley.com/doi/10.1002/stem.1024/abstract.

or follow the link below for details of how to access the full PDF content that is referenced above that abstract;

http://www.rns-pdf.londonstockexchange.com/rns/8410U_1-2012-1-2.pdf

The study was conducted in conjunction with Dr Mike Modo and colleagues at the Institute of Psychiatry, King's College London, prior to Dr Modo's recent move to the McGowan Institute for Regenerative Medicine, University of Pittsburgh.  The first clinical application for the CTX cell line is ReNeuron's ReN001 stem cell therapy for disabled stroke patients, currently in Phase I clinical development.

The newly-published data show significantly improved outcomes in the key behavioural tests in the CTX cell-treated group in a validated rodent model of stroke disability.  A gradual improvement in function was observed between 4 and 12 weeks post-implantation of the CTX cells.  Where stroke damage was confined to the striatal region of the brain, up to 83% recovery of sensorimotor function was recorded in the cell-treated group.  Up to 20% of the CTX cells were seen to differentiate into astrocytes in the cell-treated group, a neuronal cell type associated with behavioural improvements in the chronic phase of stroke.  Furthermore, implantation of the CTX cells restored Collagen IV expression to almost control levels, indicating restoration of damaged blood vessels and the formation of new blood vessels in the damaged striatal region of the brain, via the process of angiogenesis.

These results build on the findings of previous efficacy and mode-of-action studies with the CTX cells, confirming their efficacy in models of stable state stroke damage and providing further evidence of the ways in which the cells may promote recovery of function in these models.  This study also demonstrates that the size and location of the stroke lesion is an important determinant of the degree of functional recovery seen, as is the site of implantation of the cells.  Taken together, these findings therefore provide valuable information to assist in the clinical development of ReNeuron's ReN001 stem cell therapy for disabled stroke patients, both in terms of the size and location of stroke lesion targeted and the optimum route of administration of the CTX cells.

Dr John Sinden, Chief Scientific Officer of ReNeuron, commented:

"We are delighted to see the results of this important and confirmatory pre-clinical efficacy study with ReNeuron's CTX stem cell line accepted for publication.  The degree of recovery of motor function seen in this study is striking.  The results build on earlier published data using the CTX cell line in models of stroke disability and confirm the strength of ReNeuron's position in the development of cell-based treatments for eligible stroke patients disabled by ischaemic stroke, a patient population who currently have no treatments available to them. The data from this study also fully validate the clinical approach adopted in the ongoing PISCES clinical trial with our ReN001 stem cell therapy for disabled ischaemic stroke patients."

1.   Implantation site and lesion topology determine efficacy of a human neural stem cell line in a rat model of stroke Smith E, Stroemer RP, Gorenkova N, Nakajima M, Crum WR, Tang E, Stevanato L, Sinden JD, Modo M.

Enquiries:

Michael Hunt, Chief Executive Officer - ReNeuron              [phone]

Dr John Sinden, Chief Scientific Officer - ReNeuron

Lisa Baderoon, Mark Court, Isabel Podda                        [phone]

Buchanan Communications                                      

David Hart                                                                               [phone]

Daniel Stewart & Company plc                              

About ReNeuron

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 peripheral arterial disease, a serious and common side-effect of diabetes, and 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 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.

 

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