On July 4, 2023 4SC AG (4SC, FSE Prime Standard: VSC) reported that the results from the RESMAIN Study evaluating resminostat (Kinselby) in maintenance treatment of patients with advanced cutaneous T-cell lymphoma (CTCL) will be presented by Professor Dr. Rudolf Stadler at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023 on Saturday, 23rd September 2023 at 9:10h CEST at The Leiden University Medical Center in the Netherlands (Press release, 4SC, JUL 3, 2023, View Source [SID1234633032]).
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On 23 May 2023 4SC AG informed the market that resminostat (Kinselby) had met the primary endpoint in the RESMAIN study and demonstrated a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo. The study confirmed the already well known safety profile of resminostat (Kinselby) in CTCL.
RESMAIN is a pivotal study, conducted as a multi-center, double blind, randomized, placebo-controlled study, evaluating resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy, at 50 clinical centers in 11 European countries and 5 centers in Japan.
If approved by regulatory authorities, resminostat (Kinselby) would be the first histone deacetylase inhibitor approved in Europe for CTCL and the first and only drug approved for maintenance therapy in this disease, making it the Company’s most valuable asset. The positive outcome to RESMAIN creates an opportunity to either sell, license or partner 4SC’s resminostat program for commercialization worldwide (excluding Japan), where Yakult Honsha Co. Ltd, was granted an exclusive license for the development and marketing of resminostat in Japan in 2011.
Dr. Susanne Danhauser-Riedl, Chief Medical Officer of 4SC: "The RESMAIN study is the first randomised controlled trial that has proven the benefit of maintenance treatment in advanced CTCL, and we are very pleased to have successfully demonstrated the positive impact of using resminostat for patients enrolled in this study. We thank the investigators and their staff and in particular the patients that participated in the RESMAIN trial and made this success happen".