Guildford, UK, 11 August 2009: ReNeuron Group plc (LSE: RENE.L) today announces the publication of three papers in peer-reviewed journals regarding its ReN001 stem cell therapy for stroke and its lead CTX stem cell line. The CTX cell line forms the basis of ReNeuron’s principal therapeutic programmes, including the ReN001 stroke therapy.
The first paper, published in Neurorehabilitation and Neural Repair1, describes how implantation of clinical-grade CTX stem cells in rodent models of stroke promoted significant behavioural recovery, with a greater degree of recovery observed as the cell dose increased. The results in this paper confirm and extend previous published findings regarding the pre-clinical efficacious effects of the CTX cells in stroke models. The paper also describes and confirms other recently published data regarding the potential mechanism of action of the CTX cells in these models, namely that the implanted cells release elements into the brain that promote vascular growth and restoration of blood supply in the damaged areas.
The second paper, published in BMC Neuroscience2, describes key safety characteristics regarding ReNeuron’s stem cell expansion technology. This technology has been used to efficiently scale up the CTX stem cell line and is fully controllable by means of a chemical safety switch, so that it becomes inactive prior to implantation of the expanded cells. The paper describes a study in a pre-clinical model of stroke demonstrating a further safety feature of the expansion technology, whereby expression of the cell expansion transgene is shown to be silenced in vivo, thereby nullifying any adverse impact of the expansion technology after implantation of the CTX cells.
The final paper, a review article published in Current Opinion in Molecular Therapeutics3, describes recent advances in knowledge and practices toward the development of a successful neural stem cell therapy for stroke patients, referencing published pre-clinical data including those generated using ReNeuron’s CTX cell line in models of stroke. Among other issues, the paper reviews the potential mechanisms by which stem cells engender pronounced functional improvements in stroke-induced deficits and discusses the central role played by the host’s immune system in stem cell-induced neural repair.
Dr John Sinden, Chief Scientific Officer of ReNeuron, said:
“These latest peer-reviewed publications build on previously published data regarding the characteristics of our lead CTX cell line and its efficacious effects in pre-clinical models of stroke and neurodegenerative disease. Together with the extensive non-published safety and manufacturing quality data we have generated with the CTX cell line, leading to UK regulatory approval being given for clinical trials to commence with ReN001 in disabled stroke patients, we believe we now have one of the most comprehensive and compelling data packages for any cell line in the field currently being developed as a potential treatment for neurological conditions such as stroke.“
1. The neural stem cell line CTX0E03 promotes behavioural recovery and endogenous neurogenesis after experimental stroke in a dose-dependent fashion
P Stroemer, S Patel, A Hope, C Oliveira, K Pollock and J Sinden
Neurorehabilitation and Neural Repair, Jul 2009; vol. 0: pp. 1545968309335978v1.
2. C-mycERTAM transgene silencing in a genetically modified human neural stem cell line implanted into MCAo rodent brain
L Stevanato, R Corteling, P Stroemer, A Hope, J Heward, E Miljan and J Sinden
BMC Neuroscience 2009, 10:86
3. Stem cell treatment of ischaemic brain injury
E Miljan and J Sinden
Curr Opin Mol Ther. 2009 Aug;11(4):394-403
Michael Hunt, Chief Executive Officer – ReNeuron +44 (0) 1483 302560
Dr John Si nden, Chief Scientific Officer – ReNeuron
Jonathan Birt, Susan Quigley – Financial Dynamics +44 (0) 20 7831 3113
Stewart Wallace, Adam Cowen – Collins Stewart +44 (0) 20 7523 8350
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.