4SC’s pivotal RESMAIN study of resminostat in CTCL receives second positive safety review

On January 28, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that the Data Safety Monitoring Board (DSMB), an independent committee of clinical and drug safety experts, again recommends continuation of the ongoing pivotal RESMAIN study without modification of the study protocol (Press release, 4SC, JAN 28, 2019, View Source [SID1234532918]). Per the protocol’s pre-specified DSMB charter, the second DSMB meeting was scheduled recently to review cumulative safety data after 100 patients have been enrolled and completed at least one treatment cycle.

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RESMAIN is conducted as a multi-center, double blind, randomized, placebo-controlled study. It evaluates resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy, at more than 50 clinical centers in 11 European countries and Japan. The study is progressing on track, recruitment is expected to complete in 2019 and top-line results are expected in the first half of 2020.

Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, commented: "We are encouraged by the positive outcome of the second independent DSMB safety review and aim to bring resminostat to patients as quickly as possible to achieve an improvement in their quality of life.

Advanced-stage CTCL patients usually respond to available treatment options but the duration of response is often short-lived and declines as the severity of the disease increases. The aim of a maintenance therapy and thus of our RESMAIN study is to make such remissions more durable, halting disease progression."