BioCentury
ARTICLE | Clinical News

UshStat: Phase I/IIa ongoing

October 28, 2013 7:00 AM UTC

Oxford BioMedica said FDA and France's National Agency for the Safety of Medicine and Health Products (ANSM) agreed to allow the company to resume enrollment in Phase I/IIa trials of StarGen and UshStat and a Phase I trial of RetinoStat using existing clinical trial material. The company suspended enrollment in the trials after detecting "very low" concentrations of potential impurities in the material (see BioCentury, June 10). Oxford BioMedica said newly developed analytical methods confirmed the integrity and quality of the clinical trial material and that no safety concerns relating to the ocular products have been identified. Oxford BioMedica said it will work to obtain ethics committee approvals to resume recruitment in the trials.

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 trial 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). ...