Oxford BioMedica Resumes Recruitment for Retinal Gene Therapy Clinical Trials

October 17, 2013
Oxford BioMedica, a biopharmaceutical company in the United Kingdom, has received agreement from the U.S. Food and Drug Administration and the French regulatory agency ANSM to resume recruitment for its three retinal-disease, gene-therapy clinical trials. One is a Phase I study of RetinoStat® for wet age-related macular degeneration at Johns Hopkins University Hospital in Baltimore, Maryland. Another is a Phase I/IIa study of StarGen for Stargardt disease at Oregon Health & Science University (OHSU) in Portland and the Institut de la Vision in Paris, France. And the third is a Phase I/IIa study of UshStat® for Usher syndrome type 1B at OHSU and the Institut de la Vision.

In June, the company voluntarily postponed trial recruitment as a precaution while it investigated the detection of low levels of an impurity in its clinical trial material. The agreement to resume recruitment and use of existing clinical trial materials comes after Oxford BioMedica’s submission of comprehensive information to the regulatory agencies. The company will continue to monitor its clinical trial materials using state-of-the-art technologies to ensure their safety.

“Given our experience, we estimate that Oxford’s clinical trials will resume in about three months,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “The company’s gene therapies hold potential for saving vision for many people affected by devastating retinal diseases, and we are very pleased that they are back on track.”

All three of Oxford BioMedica’s retinal-disease, gene-therapy clinical trials were made possible by critical lab studies funded by the Foundation.