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Capricor to Meet with FDA under its RMAT Designation to Discuss HOPE-2 Clinical Trial
Capricor Therapeutics announced today that it will meet with the U.S. Food and Drug Administration (FDA) in December to discuss clinical trial design, surrogate or intermediate endpoints and manufacturing processes for CAP-1002, Capricor’s novel cell therapy. Currently, patients are being enrolled in the HOPE-2 clinical trial, which is investigating CAP-1002 as a therapy for the treatment of Duchenne muscular dystrophy.
The in-person meeting is part of the expedited review process afforded to Capricor for its CAP-1002 product candidate after being granted the Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in February 2018. The FDA grants the RMAT designation to regenerative medicine therapies intended to treat a serious condition and for which preliminary clinical evidence indicates a potential to address unmet medical needs for that condition.
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