Pivotal RESMAIN study of resminostat in CTCL: update at the EORTC CLTF meeting 2019 in Athens
- More than 140 patients enrolled
- Top-line results expected towards the middle of 2020
Planegg-Martinsried, Germany, 27 September 2019 - 4SC AG (4SC, FSE Prime Standard: VSC) today announced that Prof. R. Stadlerof University Hospital of Dermatology, Minden, Germany will provide an update on the ongoing pivotal RESMAIN study at the EORTC Cutaneous Lymphoma Task Force Meeting in Athens, 26-28 September 2019.
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 well and top-line results are expected towards the middle of 2020.
- Press release ends -
28 January 2019, 4SC's pivotal RESMAIN study of resminostat in CTCL receives second positive safety review
20 November 2018, 4SC reaches significant milestone with enrollment of 100 patients in pivotal RESMAIN study of resminostat as CTCL maintenance therapy
28 June 2018, New data supports resminostat's mechanism of action in CTCL maintenance therapy
27 March 2018, Yakult Honsha joins 4SC's pivotal RESMAIN study of resminostat in CTCL - 4SC receives milestone payment
4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs. 4SC's pipeline is protected by a comprehensive portfolio of patents and currently comprises two drug candidates in clinical development: resminostat and domatinostat.
4SC aims to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself.
4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 47 employees as of 30 June 2019 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).
Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor that potentially offers an approach to treating different kinds of cancer. Resminostat demonstrated that it is well tolerated and can inhibit tumor growth and proliferation, cause tumor regression, and strengthen the body's immune response to cancer.
Resminostat has been shown to be well tolerated in several clinical trials. Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) by 4SC and a Phase II study in biliary tract cancer by 4SC's development partner Yakult Honsha in Japan.
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.
About the RESMAIN study - Resminostat for maintenance treatment of CTCL
The pivotal RESMAIN study is being conducted at more than 50 clinical centers in 11 European countries and Japan. It will include up to 190 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 2020.
The concept of maintenance therapy
The pivotal RESMAIN study is focused on patients with advanced-stage, incurable cutaneous T-cell lymphoma CTCL. Such patients suffer from painful and itchy skin lesions resulting in disfigurement and a severely impaired quality of life. Furthermore, lymph nodes, blood or visceral organ can be involved. None of the current therapeutic options achieve stable disease for long periods, with most patients progressing within six months on average.
Resminostat is being evaluated as maintenance treatment - prolonging the period patients are stable and not progressing. Recent preclinical data further suggests that resminostat has the potential to alleviate the itching in CTCL patients, thereby additionally improving the quality of life for patients.
Information set forth in this press release contains forward-looking statements, which involve 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.
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