4SC AG: Overall survival benefit for resminostat in first-line liver cancer study subgroup

  • Data from a randomized, multi-center, 170 patient Phase II study with resminostat as first-line treatment of advanced liver cancer presented at 2017 Gastrointestinal Cancers Symposium
  • Substantial increase in overall survival shown in platelet-defined patient subgroup for combination treatment with resminostat and sorafenib
  • Subgroup included approximately 50% of the study population
  • Resminostat treatment resulted in this subgroup in approximately 40% reduced risk of death
  • Prospective clinical development plan for resminostat under discussion with Yakult Honsha

PLANEGG-MARTINSRIED, Germany I January 24, 2017 I 4SC AG (4SC, FSE Prime Standard: VSC) today announced that the study investigators presented the detailed scientific study analysis (abstract #252) from the multi-center, randomized, 170 patient Phase II study conducted by 4SC’s cooperation partner Yakult Honsha Co., Ltd. (Yakult Honsha) in Japan and South Korea at the 2017 Gastrointestinal Cancers Symposium in San Francisco, USA. The study evaluated 4SC’s epigenetic cancer drug resminostat in combination with sorafenib compared to sorafenib monotherapy as first-line treatment in patients with advanced liver cancer (hepatocellular carcinoma, HCC).

“As reported earlier, subgroup analysis of the Phase II study revealed that addition of resminostat to the standard of care sorafenib resulted in a prolonged time until disease progression and a substantial benefit in median overall survival in patients with a normal to high platelet count at study entry. At median, patients in this subgroup treated with resminostat and sorafenib survived for 13.7 months compared to 5.1 months in patients treated with sorafenib alone,” explains Frank Hermann, M.D., Chief Development Officer of 4SC. “For these subgroup patients with higher baseline platelet levels, the risk of death during the study was reduced by approximately 40%, which represents a substantial benefit for patients with advanced HCC who have very few therapeutic alternatives.”

What are platelets and what’s their role in liver cancer?

Platelets, also called thrombocytes, are a component of our blood whose main function is to stop bleeding. “There is increasing evidence, provided by both basic and translational research, that platelets and platelet-derived factors may promote the development and diffusion of HCC. Moreover, clinical studies have shown that increased platelet counts may be associated with a more aggressive form of HCC and poorer prognosis,” explains Prof. Edoardo Giannini, Associate Professor at the Gastroenterology Unit in the Department of Internal Medicine of the University of Genoa, Italy, and participant at the global HCC advisory board meeting of 4SC and Yakult Honsha.

Further clinical development of resminostat in advanced liver cancer

“These are the first clinical data obtained in a randomized, controlled Phase II trial conducted in patients with advanced HCC indicating that platelet count might serve as a potentially relevant selection criterion. These interesting results are worthy of further exploration in a pivotal Phase III study,” continues Prof. Giannini.

Jason Loveridge, Ph.D., CEO of 4SC, concludes: “Although baseline platelet count is not yet an established selection criterion for patients in oncology and particularly in HCC, we have received a lot of positive feedback from leading experts in the HCC field. particularly since the patients where we see most benefit, are those with more advanced disease and with poorer prognosis. The increased overall survival benefit from the combination of resminostat and sorafenib is highly encouraging and certainly worth investigating in a further clinical study. To this end we are currently discussing our plans for the further development of resminostat with Yakult Honsha.”

Further information

About Liver Cancer (Hepatocellular Carcinoma, HCC)

According to the American Cancer Society liver cancer is one of the most common types of cancer worldwide with more than 700,000 new cases in 2016. Liver cancer still is a leading cause of cancer deaths, accounting for more than 600,000 deaths worldwide each year. In the past three decades alone, the number of new cases has almost doubled and is still increasing.

Liver cancer often remains undetected until it reaches an advanced stage, resulting in a slim chance of recovery. Currently, the tyrosine kinase inhibitor sorafenib is the only approved drug-based first-line therapy for patients with advanced liver cancer and standard of care.

About Resminostat

Resminostat is an orally administered epigenetic anti-cancer compound. As an inhibitor of HDAC (histone deacetylase) that targets class I, IIB, and IV HDACs, resminostat can reactivate silenced genes in cancer cells or downregulate abnormally expressed genes. In addition to its direct effects, resminostat enhances the body’s own immune response to cancer.

Resminostat is in development both as monotherapy and in combination with other drugs. The compound has been shown to be well tolerated in Phase I studies, and its use in the treatment of cutaneous T-cell lymphoma, Hodgkin’s lymphoma and liver, lung, colon, pancreatic and biliary tract cancers is being or was investigated in further clinical studies. Initial positive efficacy results for resminostat monotherapy have already been observed in patients with Hodgkin’s lymphoma and in combination with the standard medication sorafenib in selected patients with advanced liver cancer.

About epigenetic cancer therapy

Epigenetic changes modify the activity of certain genes, but not the genetic code of DNA itself, causing activation or silencing of genes. This mechanism enables differentiated cells such as those in the lungs, nerves or skin to serve very different functions despite containing identical genetic code.

Epigenetic alterations are as important as genetic mutations in a cell’s transformation to cancer; however, their manipulation holds great promise for cancer therapy. Epigenetic compounds such as 4SC’s resminostat and 4SC-202 may convert these malignant epigenetic alterations back to a normal or non-malignant state. For example, treatment with epigenetic cancer compounds interrupts or combats the mechanism that is responsible for the onset of cancer, makes cancer cells visible to the body’s own immune system or renders them more responsive to immuno-oncological treatment.

Epigenetic therapeutics is considered as a future growth market in the field of oncology based on its significant promise as both a monotherapy and in combined approaches with immuno-oncology drugs and other therapeutic agents. In an October 2015 report by business information publisher Grand View Research, the worldwide epigenetics market was projected to generate revenues of US-$16 billion in 2022, up from US-$ 4 billion in 2014.

About 4SC

4SC AG (4SC, FSE Prime Standard: VSC, www.4sc.com) is a clinical-stage biopharmaceutical company dedicated to the development of small-molecule drugs focused on epigenetic mechanisms of action for the treatment of cancers with high unmet medical needs. These drugs are intended to provide innovative treatment options for cancer patients that are more tolerable and efficacious than existing therapies, provide a better quality of life and offer increased life expectancy. The Company’s pipeline comprises promising products that are in various stages of clinical development. 4SC’s aim is to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies. Founded in 1997, 4SC had 47 employees as of 30 September 2016. 4SC has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.


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