Posted by Michael Wonder on 05 Feb 2018
Capricor receives FDA regenerative medicine advanced therapy designation for Duchenne muscular dystrophy therapy
5 February 2018 - CAP-1002 to benefit from expedited review program for drugs for unmet needs.
Capricor Therapeutics today announced that the U.S. FDA has granted CAP-1002, its lead investigational cell therapy for the treatment of Duchenne muscular dystrophy, (DMD), the regenerative medicine advanced therapy designation.
Capricor is launching a potential registration trial, the HOPE-2 Trial, to test the potential benefit of CAP-1002 as a multi-dose therapy delivered intravenously. HOPE-2 is a randomized, double-blind, placebo-controlled clinical trial that is planning to enroll approximately 84 participants in advanced stages of DMD.
