The U.S. Food and Drug Administration has approved Capricor’s application to conduct a new trial for their cardiac cell therapy, CAP-1002. The US-based phase 2 trial, HOPE-2, is expected to be initiated in the first quarter of 2018. It will evaluate the safety and efficacy of repeated intravenous injections of CAP-1002, in individuals with Duchenne muscular dystrophy.
If the trial reaches its primary endpoint, Capricor believe HOPE-2 could serve as a registration trial. This means the data could be used to support the submission of a Biologics License Application to obtain marketing approval of CAP-1002.
For more information read Capricor Therapeutic’s press release.