FDA PARTIALLY LIFTS CLINICAL HOLD ON CORAUTUS GENETICS TRIAL
The FDA has partially lifted a clinical hold it imposed March 29 on a clinical trial conducted by Corautus Genetics. The hold was due to adverse events involving devices manufactured by Boston Scientific, the firm announced July 13.
While the company has satisfactorily addressed the majority of the problems with its GENASIS Phase IIb clinical trial, its investigational new drug application will remain on a "partial hold," while problems related to the Stiletto catheter delivery system supplied by Boston Scientific and the injection procedure are sorted out, Corautus said.
The clinical hold was originally imposed at the Atlanta-based company's own request after it voluntarily suspended the trial on March 14, following three serious adverse events that occurred within 10 days.