Guildford, UK, 15 June 2012: ReNeuron announces that, following yesterday’s announcement of interim Phase I clinical data with its ReN001 stem cell therapy for disabled stroke patients, the Company is also presenting further positive pre-clinical data across its other therapeutic programmes at the 10th Annual Meeting of the International Society for Stem Cell Research in Yokohama, Japan, running from 13-16 June 2012.
Two poster presentations relate to ReNeuron’s ReN009 therapy targeting critical limb ischaemia, the end-stage of peripheral arterial disease, 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 Company’s researchers and academic collaborators at the Bristol Heart Institute are presenting data with ReN009 from a pivotal pre-clinical study examining different manufacturing formulations of the Company’s lead CTX stem cell line (used in both the Company’s ReN001 stroke and ReN009 therapies). The results of the study showed equivalent efficacy in a rodent model of critical limb ischemia, regardless of cell formulation. The treatment formulations tested included freshly prepared CTX cells prior to treatment, formulations of cryopreserved CTX cells using differing freezing media (and thawed prior to treatment), and a formulation of CTX cells incorporating the luciferase gene which allows the cells to be tracked post-implantation. In a further study, the researchers show that the ReN009 treatment appears to modulate early host immune responses in a rodent model of the disease, allowing an acceleration of muscle regeneration in the damaged limb.
A further two further poster presentations relate to ReNeuron’s ReN003 therapy, initially targeting retinitis pigmentosa, a blindness-causing, degenerative disease of the retina. The Company’s researchers and academic collaborators at the Schepens Eye Research Institute, Massachusetts Eye and Ear are presenting data from a number of pre-clinical studies with the Company’s human retinal progenitor cells (hRPCs) used in the ReN003 therapy. The data demonstrate that the hRPCs differentiate into cells expressing the appropriate cell surface markers for photoreceptors, the cells lost in retinitis pigmentosa patients. These surface markers may be used to enable the enrichment or depletion of the hRPC cell population prior to transplantation. In rodent models of the disease, transplanted hRPCs migrated into the outer nuclear layer of the host retina whilst preserving the characteristics of mature photoreceptors. The data from the studies also demonstrated that the use of thin film scaffold technology may provide a means to organize and pre-differentiate hRPCs in a controlled manner before transplantation.
In a final poster presentation, ReNeuron’s researchers present further in vitro data with the CTX cell line, demonstrating the ability of the CTX cells to differentiate into neuronal and glial cell types on commercially available three-dimensional scaffolds, at a rate greater than that seen when utilising conventional two-dimensional substrates. These observations provide greater potential for future studies into the effects of CTX cells on the factors that regulate neural development in the brain.
The Company expects to file later this year for approval to commence a multi-centre clinical trial with ReN009 in critical limb ischaemia patients and is targeting a clinical trial filing for ReN003 in the latter part of 2013 in patients with retinitis pigmentosa.
John Sinden, Chief Scientific Officer of ReNeuron, said:
“We are delighted to be able to present a significant body of new work at this week’s ISSCR conference, demonstrating the versatility, robustness and future potential of our CTX and hRPC stem cell assets for the treatment of degenerative diseases. In particular, the apparent potency of the CTX cells in models of critical limb ischaemia across a range of manufacturing formulations bodes well for future commercial scale-up and manufacturing of this product.
Much of the work being presented has been undertaken in conjunction with leading academic collaborators in their respective fields and we thank them for their ongoing support of our therapeutic programmes.”
- ReNeuron +44 (0) 1483 302560
Michael Hunt, Chief Executive Officer
Dr John Sinden, Chief Scientific Officer
- Buchanan +44 (0) 20 7466 5000
Mark Court, Sophie Cowles
Cenkos Securities +44 (0) 20 7397 8900
Stephen Keys, Adrian Hargrave (NOMAD and Broker)
Andy Roberts (Sales)
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.