4SC AG: Progress update on pivotal RESMAIN study of resminostat in CTCL at 13th Congress of the EADO(PresseBox) (Planegg-Martinsried, Germany, )
RESMAIN - pivotal 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
Patient enrollment and study center openings on track; study expected to enroll 150 patients at more than 50 clinical centers in 11 European countries
Top line results expected in early 2019
4SC AG (4SC, FSE Prime Standard: VSC) today announced, that 4SC and investigators present a progress update on the pivotal RESMAIN study, a European multi-center, double blind, randomized, placebo-controlled study to evaluate the histone deacetylase (HDAC) inhibitor 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.
"There are two HDAC inhibitors currently available in the U.S. to treat CTCL, but these are indicated only for treatment of patients with progressive disease and, to date, none are approved in Europe," said Frank Hermann, M.D., Chief Development Officer of 4SC. "Based on our knowledge of resminostat's mechanism of action, we took a unique and differentiated approach by evaluating resminostat as a maintenance therapy in patients with advanced stage CTCL who have achieved disease control to prior systemic therapy.
CTCL inflicts a very high disease burden on patients, who mainly suffer from painful and itchy skin lesions, resulting in severe disfigurement. In advanced disease stages patients also present with skin tumors and/or involvement of blood, lymph nodes or visceral organs. Prolonging the relief following prior treatment and increasing the quality of life of patients would be a great medical success and benefit for the patients."
Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, added: "We thank the patients for participating in the RESMAIN study and the study teams and investigators for their efforts and contribution. The study is progressing in line with our expectations with about two thirds of study sites open for enrollment in 7 European countries and already 13 patients being randomized at 8 active sites. Overall, we aim to enroll 150 patients at more than 50 clinical centers in 11 European countries. Presenting this study update at the EADO meeting is a great opportunity to generate broader attention for the RESMAIN study."
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.
ePoster on site
P005 | 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
The poster is available for download at 4SC's website.
28 February 2017, 4SC to present supportive preclinical data on resminostat's potential as maintenance therapy for CTCL
24 January 2017, Overall survival benefit for resminostat in first-line liver cancer study subgroup
16 December 2016, First patient enrolled in pivotal RESMAIN study of resminostat in CTCL
About the RESMAIN study - Resminostat for maintenance treatment of CTCL
The RESMAIN pivotal study is open for recruitment since November 2016 and is being conducted at more than 50 clinical centers in 11 European countries. It will include 150 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) and have achieved disease control with systemic therapy. The patients are 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.
The primary goal of the study is to determine whether maintenance treatment with resminostat prolongs progression-free survival and the key secondary objective is to prolong the time to symptom worsening (itching). A comprehensive biomarker program is also included in the study to ensure vital knowledge about the biological background of resminostat treatment and CTCL is acquired. 4SC anticipates top-line data to be available in 2019.
About cutaneous T cell lymphoma (CTCL)
CTCL is a rare disease with approximately 5,000 patients being newly diagnosed in Europe each year. The disease arises from malignant transformation of T cells, a specialized subgroup of immune cells, primarily affects the skin, but may ultimately involve lymph nodes, blood and visceral organs.
Currently, CTCL is not curable and treatment options for advanced-stage CTCL are limited. Although patients respond to the available treatment options, the duration of response is often short-lived and declines as the severity of the disease increases. The key therapeutic challenge in advanced-stage CTCL is therefore to make remissions more durable, halting disease progression, improving quality of life and prolonging progression free and overall survival.
Resminostat is an orally administered histone deacetylase (HDAC) inhibitor with an epigenetic mechanism of action that potentially offers a novel approach to treating a wide variety of cancers, both as monotherapy and - in particular - in combination therapy with other anti-cancer drugs. As an inhibitor that blocks HDAC classes I, IIB and IV, resminostat can potentially offer benefit to patients as it inhibits tumor growth and proliferation, causes tumor regression, and strengthens the body's own immune response to cancer.
Resminostat has been shown to be well tolerated in patients with advanced cancers in Phase I studies. Its use in the treatment of cutaneous T-cell lymphoma (CTCL), Hodgkin's lymphoma and liver, lung, colon, pancreatic and biliary tract cancers has been and is being investigated in further clinical studies. Initial positive efficacy results for resminostat have - amongst others - been observed in combination with the standard medication sorafenib in selected patients with advanced liver cancer (hepatocellular cancer, HCC).
Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond 4SC's control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.