Guildford, UK, 8 April 2011: ReNeuron Group plc (LSE: RENE.L) today announces that it is expanding its contract manufacturing arrangements in the UK by signing an agreement with NHS Blood and Transplant (NHSBT) to develop and manufacture its CTXcryoTM stem cell product to clinical and commercial grade standards.
Following completion of ongoing technology transfer work, NHS Blood and Transplant (NHSBT) will use their state-of-the-art, accredited cell manufacturing facilities to develop and manufacture ReNeuron’s next-generation CTXcryoTM frozen stem cell product for pre-clinical development work and eventual clinical use in the Company’s ReN009 programme for peripheral arterial disease and in other future therapeutic programmes.
The CTXcryoTM cell product is a second-generation formulation of ReNeuron’s lead CTX stem cell line, the basis of its ReN001 therapy for stroke, currently in early clinical development. This new formulation has been developed to address the logistical issues typically associated with the distribution and wide-scale clinical use of whole cell-based therapies such as those ReNeuron is taking forward into clinical development. The CTXcryoTM cells can be readily manufactured to full GMP standards, frozen down for storage and distribution, and simply thawed when required at the point of clinical use.
The manufacturing arrangements with NHSBT complement ReNeuron’s ongoing contract manufacturing arrangements with Angel Biotechnology plc in Scotland, where product development and testing also takes place with ReNeuron’s cell products and where its CTX cells are manufactured for clinical use in the Company’s ReN001 stroke programme. The Company intends to further broaden its contract manufacturing arrangements into other territories, including the US, in due course in order to meet the needs of its ongoing clinical and product development strategy.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“We are delighted to be extending our collaboration with the NHS through these contract manufacturing arrangements. Although further optimisation work remains to be done, the transfer of the production process for the CTXcryoTM cells to NHSBT represents an important milestone in our product development and cell manufacturing strategy and is a further step towards realising our vision to develop safe, effective and readily scalable stem cell-based therapeutics for wide-scale patient use in significant disease conditions.“
Michael Hunt, Chief Executive Officer – ReNeuron +44 (0) 1483 302560
Dr John Sinden, Chief Scientific Officer – ReNeuron
Lisa Baderoon, Mark Court, Isabel Podda +44 (0) 20 7466 5000
Antony Legge, Oliver Rigby +44 (0) 20 7776 6550
Daniel Stewart & Company plc
James Gallagher, Tim Graham +44 (0) 20 3206 7000
Matrix Corporate Capital LLP
About NHS Blood and Transplant
NHS Blood and Transplant (NHSBT) is the UK’s major provider of human tissue, stem cells and organs for Transplant and has research and development teams providing a deep skillbase in working with cellular therapies. To support this work, the Liverpool facility has a dedicated research and development team and a purpose built Development Laboratory, for translational research. It therefore has the skills to work on the improvement of existing processes and products and the development of innovative procedures and therapies. This ensures that NHSBT is at the forefront of tissue engineering and cellular therapy developments.
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 early clinical development. ReNeuron’s ReN009 stem cell therapy is being developed as a treatment for peripheral arterial disease, a serious and common side-effect of diabetes. The Company is also developing stem cell therapies for other conditions such as 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 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.