RENE.L Regulatory News (RENE)

10 Sep 2009 07:00



ReNeuron signs manufacturing contract for second-generation CTX stem cell product

Guildford, UK, 10 September 2009: ReNeuron Group plc (LSE: RENE.L) today announces that it has signed a contract with Angel Biotechnology Holdings plc ("Angel"), under which Angel will manufacture clinical-grade lots of a second-generation formulation of ReNeuron's lead CTX stem cell line, for subsequent pre-clinical and clinical applications.

The new formulation enables the CTX cells to be readily frozen down for shipping and storage, and thawed at the point of use. This process enables a greatly enhanced shelf life for the product and the capability to ship the cells for clinical and commercial application anywhere on the globe. In due course, the Company plans to utilise this enhanced CTX cell formulation for multi-centre, proof-of-concept clinical trials with its ReN001 stem cell therapy for disabled stroke patients, as well as for late pre-clinical testing and initial clinical trials with its ReN009 stem cell therapy for peripheral artery disease.

Michael Hunt, Chief Executive Officer of ReNeuron, said:

"We are pleased to have further extended our cell manufacturing collaboration with Angel. Our new CTX cell formulation has shown great promise during in-house development work and this contract marks an important step in realising ReNeuron's vision to develop a readily scalable and truly commercial stem cell-based therapeutic for wide-scale patient use."

Enquiries:

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.

About Angel Biotechnology Holdings plc

Angel Biotechnology Holdings plc is a biomanufacturing company offering process development services and GMP manufacturing for advanced biologics, supporting biotechnology and pharmaceutical companies worldwide. Angel's principal activity is the manufacture and supply of materials for use in early stage drug development and pre-clinical studies, along with drug product and CMC documentation for Phases I, II and III clinical trials and the manufacture of licensed drugs or vaccines. Angel specialises in the provision of advanced biologics; these include autologous and allogeneic cell therapy products, stem cells, cellular vaccines, specific purified natural and recombinant proteins and bacteriophage. Angel is managed by a team with wide-ranging experience in biopharmaceutical manufacture, gained in companies such as Glaxo, Johnson and Johnson, Serologicals Inc., PPL Therapeutics and Intercell Ag.

Angel was admitted to trading on AIM in November 2005.