DGAP-News: 4SC's pivotal RESMAIN study of resminostat in CTCL receives second positive safety review

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

• Independent Data Safety Monitoring Board (DSMB) recommends RESMAIN study to continue without modification
• Pivotal study evaluates resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL)
• Top-line results expected in the first half of 2020

Planegg-Martinsried, Germany, 28 January 2019 - 4SC AG (4SC, FSE Prime Standard: VSC) today announced 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. 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.

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."

- Press release ends -

Related articles

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

Further information

About 4SC

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 three key drug candidates in various stages of preclinical and clinical development: resminostat, domatinostat (4SC-202) and 4SC-208.

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 46 employees as of 30 September 2018 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

About resminostat

Resminostat is orally administered and potentially offers a novel approach to treating a wide variety of cancers, both as monotherapy and in combination therapy with other anti-cancer drugs. Resminostat inhibits tumor growth and proliferation, causes tumor regression, and strengthens 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. Amongst others, resminostat has previously been investigated in biliary tract or pancreatic cancer and hepatocellular carcinoma (HCC).

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 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.

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.

Forward-looking information

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.

Contact

4SC
Anna Niedl, Ph.D., CIRO
Corporate Communications & Investor Relations
anna.niedl@4sc.com
+49 89 700763-66

LifeSci Advisors
Hans Herklots
Managing Director
hherklots@lifesciadvisors.com
+41 79 598 7149