The RESMAIN study (NCT02953301) is being conducted at about 50 clinical centers in 10 European countries, and is expected to include roughly 150 adult patients with advanced stage mycosis fungoides or Sézary syndrome — two CTCL subtypes.
Only those who present least stable disease, partial response, or complete response after prior systemic therapy are eligible for the study.
The trial’s main goal is to determine if resminostat can increase progression-free survival (PFS) in these patients compared to a placebo. The secondary outcome will determine whether the treatment can increase the time until itching (pruritus) worsens. Severe skin itching represents a significant burden for CTCL patients.
Additional RESMAIN details will be presented by 4SC’s product manager, Matthias Borgman, at the EORTC CLTF Meeting 2017 | Cutaneous Lymphomas: Insights & Therapeutic Progress, Oct. 13-15 in London.
The poster is titled “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 RESMAIN Study,” and will be presented Oct. 15.
Resminostat is an oral histone deacetylase (HDAC) inhibitor that has the potential to modulate the activity of genes involved in tumor progression and metastasis, and to boost immune responses against cancer cells.
Preclinical studies showed that resminostat inhibits the progression of CTCL, stabilizing cancer cells in a less advanced malignant stage, or reversing advanced stages of the disease into less advance stages. The drug may therefore have the potential to treat progressive disease states and be used as a maintenance therapy in less advanced stages of the disease.
In addition to its anti-tumor activity, new findings, which will also be presented by Borgman at the meeting, suggest that resminostat can also reduce CTCL-associated itching, one of the major disease burdens in affected patients.
The poster, “Resminostat’s action in CTCL — hints from a genome-wide study,” shows that exposing CTCL cells to resminostat reduced the levels of a key signaling molecule, called interleukin-31 (IL-31). This molecule is produced by malignant cells and is involved in the constant itching sensation patients experience.
Roland Baumgartner, PhD, chief scientific officer of 4SC, said in a press release the new data provides important new knowledge about how resminostat alleviates itching in CTCL patients.
“In addition, given that time to symptom worsening is one of the major endpoints in our RESMAIN study, these data support our clinical development plans to advance resminostat to market authorization and to offer a new and effective treatment option to CTCL patients and physicians,” Baumgartner said.