BioCentury
ARTICLE | Clinical News

FDA places clinical hold on Sarepta's DMD gene therapy

July 27, 2018 6:19 PM UTC

Sarepta Therapeutics Inc. (NASDAQ:SRPT) and partner Nationwide Children’s Hospital said FDA placed a clinical hold on a Phase I/IIa trial of their Duchenne muscular dystrophy gene therapy, AAVrh74.MHCK7.micro-Dystrophin.

The partners said the hold is due to a trace amount of DNA fragment found in research-grade third-party supplied plasmid, though preliminary testing from Nationwide Children's Hospital suggests the trace fragment does not result in protein expression and is quickly cleared...