Clinical Trials

Date: 2017-05-03

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at the 13th Congress of the European Association of Dermato-Oncology

Company: 4SC (Germany)

Product: resminostat (oral pan-histone deacetylase (HDAC) inhibitor)

Action mechanism: histone deacetylase inhibitor (HDAC inhibitor). Resminostat is an oral pan-histone-deacetylase (HDAC) inhibitor with an innovative, epigenetic mechanism of action that enables this compound to be deployed as a novel, targeted tumour therapy for a broad spectrum of oncological indications, particularly in combination with other anti-cancer drugs. Like other epigenetic therapies, resminostat has been shown to modify transcription of genes in cancer cells and, thereby, to reprogram the phenotypes of such cancer cells. Resminostat is therefore assumed to be able to halt tumour progression and induce tumour regression. Furthermore, due to its epigenetic mode of action resminostat is supposed to develop additional synergetic effects when combined with classical cancer therapies and thus also fight the development of tumour cell resistance.

Disease: mycosis fungoides, Sezary syndrome, advanced-stage cutaneous T-cell lymphoma (CTCL).

Therapeutic area: Cancer - Oncology

Country: Belgium, Germany, Netherlands, Poland, Spain, Switzerland, UK

Trial details:

  • The RESMAIN Study is a multicentre, double blind, randomised, placebo-controlled, phase II trial to evaluate resminostat for maintenance treatment of patients with advanced stage (stage IIB-IVB) mycosis fungoides (MF) or Sézary syndrome (SS) that have achieved disease control with systemic therapy. The purpose of this study is to determine whether resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have recently achieved disease control with previous systemic therapy.
  • The study is being conducted at more than 50 clinical centers in 10 European countries. It will include 150 patients who suffer from advanced-stage CTCL who have achieved disease control with systemic therapy. The patients will be randomized 1:1 to receive either resminostat or placebo. Patients who experience disease progression - while being on placebo - will be offered resminostat in an open label treatment arm. (NCT02953301)

Latest news:

  • • On May 3, 2017, 4SC announced, that 4SC and investigators present a progress update on the pivotal RESMAIN study to evaluate resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy. The poster is presented at the 13th Congress of the European Association of Dermato-Oncology, 3-6 May 2017, in Athens, Greece. About two thirds of study sites are open for enrollment in 7 European countries and already 13 patients are being randomized at 8 active sites. 4SC expects top-line results in early 2019. If the results are positive, 4SC will submit the data to the relevant regulatory agencies for market approval of resminostat as maintenance therapy for CTCL.
  • • On December 16, 2016, 4SC AG announced enrollment of the first patient in the RESMAIN study, a European multicenter, double blind, randomized, placebo-controlled, pivotal study to evaluate the epigenetic cancer drug resminostat for maintenance treatment  of patients suffering from advanced-stage cutaneous T-cell lymphoma. A comprehensive biomarker program is also included in the study to ensure vital knowledge about the biological background of resminostat treatment andcutaneous T-cell lymphoma is acquired. 4SC anticipates top-line data to be available in 2019.
  • •  On November 10, 2016, 4SC announced the initiation of the RESMAIN study in advanced-stage cutaneous T-cell lymphoma (CTCL) in Q4 2016. This phase II study of resminostat aims to enroll 150 patients in 10 European countries at about 50 trial centers, with the goal of achieving regulatory approval for resminostat in this indication in the EU.

Is general: Yes