On November 8, 2021 4SC AG (4SC, FSE Prime Standard: VSC) reported that the 190th patient was enrolled into the pivotal RESMAIN study of resminostat in cutaneous T-cell lymphoma (CTCL) (Press release, 4SC, NOV 8, 2021, View Source [SID1234594663]). Patients with advanced stage Mycosis fungoides or Sézary syndrome have been recruited in 11 European countries and Japan with the objective to evaluate resminostat as maintenance treatment. The study has now reached its enrolment target but will continue to recruit patients into 2022 as 4SC believes this is the fastest route to reach the 125 events required for unblinding the study, which is now expected in the middle of 2023.
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Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, commented: "Maintenance therapy is a novel approach with significant potential to benefit patients with CTCL. RESMAIN is the largest clinical study of maintenance therapy in CTCL, so to succeed in recruiting our targeted patient number of nearly 200 patients is a fantastic achievement for the 4SC team and everyone involved in the study. We are extremely pleased to achieve this important milestone despite the challenges of the Corona pandemic during the past 18 months. We believe that resminostat with its epigenetic mode of action can make a major contribution to the treatment of CTCL and now look forward to unblinding of the study and data read out, which is expected in the middle of 2023."