BioCentury
ARTICLE | Clinical News

UshStat: Phase I/IIa suspended enrollment

June 10, 2013 7:00 AM UTC

Oxford BioMedica suspended enrollment in a Phase I trial of RetinoStat and Phase I/IIa trials of StarGen and UshStat after detecting "very low" concentrations of potential impurities in clinical trial material. The company believes the impurities are derived from a widely used third-party raw material. Oxford BioMedica said there were no safety concerns identified in preclinical or clinical testing of the products and there is no reason to believe that the safety profile of the products will be affected. Oxford BioMedica said it plans to resume the trials as soon as possible.

RetinoStat is designed to deliver 2 anti-angiogenic genes, endostatin and angiostatin, directly to the retina and is in an open-label, dose-escalation, U.S. Phase I testing for wet age-related macular degeneration (AMD). The trial is evaluating 3 dose levels of RetinoStat in about 18 patients. Sanofi has an exclusive option for a worldwide license to develop and commercialize RetinoStat under an April 2009 deal (see BioCentury, May 4, 2009 & July 9, 2012). ...