welcome to DuchenneXchange
- a positively charged Duchenne muscular dystrophy community.- join today!
- login
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.
rareRelated
-
Registry of Translarna (Ataluren) in Nonsense Mutation Duchenne Muscular DystrophyThis study is being performed as a post-...
-
Pediatric Radio Frequency Coils GenericThe purpose of this study is to evaluate...
-
Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrop...it is a randomised, double blind, parall...
-
Study of DS-5141b in Patients With Duchenne Muscular DystrophyThis is a phase I/II study to evaluate t...
-
FDA and NIH to loosen oversight of gene therapy developmentCiting the need to safely expedite the d...
-
Preliminary Data and Intention to Dose Escalate in IGNITE DMDToday we announced our intention to move...
-
Wave Life Sciences Announces Suvodirsen Phase 1 Safety and Tolerability Data and Phase 2/3 Clinical Trial DesignWave Life Sciences Ltd., a clinical-stag...
-
Peptide-Conjugate Antisense Based Splice-Correction for Duchenne Muscular Dystrophy and Other Neuromuscular DiseasesDuchenne muscular dystrophy (DMD) is an ...
-
Insurers battle families over costly drug for fatal diseaseNolan and Jack Willis, twins from upstat...
