Guildford, UK, 18 March 2010: ReNeuron Group plc (LSE: RENE.L) today announces that it has signed two further clinical-grade stem cell manufacturing contracts with Angel Biotechnology Holdings plc (“Angel”), in support of ReNeuron’s recently approved first-in-man clinical trial with its ReN001 stem cell therapy for stroke patients. Under these contracts, Angel will manufacture further drug substance lots of ReN001 for administration to patients in the trial, along with the provision of manufacturing process validation services. The cost of the drug product manufacture is being met by a recently-awarded grant from the UK Government’s Technology Strategy Board, under its Regenerative Medicine Programme.
The “PISCES” clinical trial (Pilot Investigation of Stem Cells in Stroke) will take place through the NHS at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. In this ground-breaking Phase I trial, the world’s first using expanded neural stem cells in this indication, ReNeuron’s ReN001 stem cell therapy will be administered to stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. The trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“We are pleased to continue to work with Angel as our chosen contract manufacturing partner for the PISCES clinical trial for ReN001 in stroke. Angel has consistently demonstrated its strong expertise in the field of regulatory-compliant cell manufacture, meeting ReNeuron’s needs for this important first-in-man study.”
Notes to editors
Angel Biotechnology Holdings plc is a biomanufacturing company offering process development services, GMP manufacturing for advanced biologics and regulatory support including preparation of dossiers for regulatory submissions. Angel has a global business 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 including autologous and allogeneic cell therapy products including stem cells and 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. More information about the company can be found at www.angelbio.com.
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 regulatory approval for a Phase I clinical trial in the UK with its lead ReN001 stem cell therapy for disabled stroke patients. Patient recruitment for this trial is expected to commence shortly. The Company is also 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.
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.
Michael Hunt, Chief Executive Officer
Dr John Sinden, Chief Scientific Officer
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