Oxford, UK – 3 June 2013: Oxford BioMedica (“Oxford BioMedica” or “the Company”) (LSE: OXB), the leading gene-based biopharmaceutical company, today announces that it has voluntarily paused recruitment into the RetinoStat® Phase I, StarGen™ Phase I/IIa and UshStat® Phase I/IIa studies, as a precautionary measure, whilst the Company investigates the recent detection of very low concentrations of potential impurities derived from a widely-used third party raw material.
A new, highly sensitive test method has recently been introduced into the Company’s wide range of analytical methods and quality assurance processes used for routine batch testing. Using this method, potential impurities have been detected at very low concentrations in clinical trial material. No safety concerns relating to any of the aforementioned products have been identified in any pre-clinical and clinical data generated to date and there is no reason to believe that the favourable safety profile of these products will be affected.
Such precautionary measures are routine and Oxford BioMedica is working very closely with the regulatory authorities to complete its investigations. The Company is committed to resuming the clinical trials as soon as possible and will continue to keep the market informed as appropriate.
Notes to editors
About Oxford BioMedica®
Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy company focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the “Group”) have built a sector leading lentiviral vector delivery platform (LentiVector®) through which the Group develops in vivo and ex-vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Sanofi, GSK, and Immune Design, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 250 people. Further information is available at www.oxfordbiomedica.co.uk.
For further information please contact
Oxford BioMedica plc
John Dawson, Chief Executive Officer
Stuart Paynter, Chief Financial Officer
Tel: +44 (0)1865 783 000
Consilium Strategic Communications – Media Enquiries
Mary-Jane Elliott/Matthew Neal/Philippa Gardner/Laura Thornton/Rosie Phillips
Tel: +44 (0)20 3709 5700