AVI Biopharma reported delay in the initiatioin of the phase II trial:
AVI BioPharma announced that the protocol for the phase II trial using eteplirsen being assessed for the treatment of Duchenne muscular dystrophy has not been approved by the Institutional Review Board of the Nationwide Children's Hospital in Columbus, Ohio. The IRB request the company to modify
the trial protocol.
The request from the IRB was not related to safety or any expected activity related to eteplirsen. The company said it is currently reviewing the request from the IRB and plans to submit the revised protocol to the IRB later this month.
The company expected to initiate the phase 2 trial in the third quarter 2012.
Above news seems to be another blow on the hopes we have from clinical trials. Before this i heard that Phase 2 trials will start in June 11 and some pivotal trials are scheduled for second half of year 2012. Now with revised protocol submission and another round of review by IRB before approval, i believe this will delay the whole process.
last 7 minutes of interview talks about duchenne