Rocket Pharmaceuticals (NASDAQ:RCKT) announces clearance from the Spanish Agency for Medicines and Health Products to commence enrollment in the FANCOLEN-II Phase 2 registration-enabling study of RP-L102 for Fanconi Anemia (FA) in Spain.
The primary endpoint of the trial is the emergence of mitomycin-C resistance in bone marrow colony forming (progenitor) cells.
A surrogate endpoint is a diepoxybutane chromosomal stability of peripheral blood T-lymphocytes.
The trial will enroll up to five pediatric patients in Europe. The study will enroll younger patients who have not developed severe bone marrow failure. The study is designed to assess the benefit/risk profile of RP-L102.
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