— Newly developed, state-of-the-art analytical methods confirm the integrity and quality of Oxford BioMedica’s LentiVector® platform products —
Oxford, UK – 17 October 2013: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), the leading gene-based biopharmaceutical company, today announces that it has received agreement from the US Food and Drug Administration (FDA) and the French regulatory agency, ANSM, to resume recruitment into the RetinoStat® Phase I, StarGen™ Phase I/IIa and UshStat® Phase I/IIa studies using the existing clinical trial material.
In June 2013, Oxford BioMedica announced that it had voluntarily paused recruitment into the aforementioned studies, as a precautionary measure, whilst the Company investigated the detection of very low concentrations of a potential impurity in its clinical trial material derived from a third party raw material. Oxford BioMedica has since performed extensive characterisation studies using its newly developed, state-of-the-art analytical methods to identify the impurity as highly fragmented DNA derived from foetal bovine serum (FBS), the most widely-used growth supplement for cell culture media. In light of these findings, Oxford BioMedica remains convinced of the safety, integrity and quality of its LentiVector® platform products and no safety concerns relating to any of the ocular products have been identified in any pre-clinical and clinical data generated to date.
Following the submission of a comprehensive data package to FDA and ANSM, Oxford BioMedica has received agreement from both agencies to resume recruitment into its ocular clinical trials using the existing clinical trial material. The Company will continue to use highly sensitive, state-of-the-art analytical methods to ensure the quality and integrity of its lentiviral vector products and will work with FDA and ANSM to define the necessary specifications for future batches of clinical trial material.
Oxford BioMedica is now working closely with the clinical trial centres to obtain the necessary ethics committee approvals in order to resume recruitment into the ocular clinical studies.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: “We value our relationships with the regulatory authorities and are pleased that, on the basis of our extensive technical investigations to demonstrate the integrity of our products, FDA and ANSM agree with our proposal to resume treating patients in our ocular trials as soon as possible.
“We place the highest importance on safety, and our analytical methods and quality assurance processes are continuously evolving to ensure that we remain at the forefront of gene therapy development and manufacture. I am confident that, with significant opportunities ahead such as the recently-announced AMSCI project win, Oxford BioMedica will continue to lead the way in delivering novel gene therapies to patients.”