17th Oct 2013 09:10
LONDON (Alliance News) - Biopharmaceutical company Oxford BioMedica PLC Thursday said it had been given permission by US and French regulators to restart recruitment into clinical trials, after the trials were paused when potential impurities were found in trial material.
The company said it will resume the trials of RetinoStat, StarGen and UshStat after being given permission to do so by the US Food and Drug Administration and the French regulatory agency ANSM.
Oxford BioMedica paused the trials in June after detecting very low concentrations of a potential impurity in its clinical trial material that its said was derived from a third-party raw material. It said it has identified the impurity as highly fragmented DNA derived from foetal bovine serum, the most widely-used growth supplement for cell culture media, and therefore is convinced its products are safe.
"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," Chief Executive John Dawson said in a statement.
Oxford BioMedica shares were up 3.9% at 2.42 pence Thursday morning.
By Steve McGrath; [email protected]; @stevemcgrath1
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