4SC obtains key patent for anti-cancer compound resminostat in China

Due to large market size and high occurrence of liver cancer, China is of key strategic importance for the further development and commercialisation of resminostat

Planegg-Martinsried, (PresseBox) - 4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, today announced that the company has significantly enhanced the patent protection for its lead anti-cancer compound resminostat. 4SC has received a notification of allowance for patent protection of resminostat in China, the third largest pharmaceutical market worldwide, from the Chinese patent authority (SIPO). Thus the granting of the composition-of-matter patent is now imminent. The patent, having a very broad extent of protection, covers the composition of matter of resminostat, pharmaceutical compositions comprising resminostat, and its therapeutic use in cancer and other areas.

China is by far the country with the highest incidence rates of liver cancer in the world and, therefore, of key importance for the further development and commercialisation of resminostat. Liver cancer (hepatocellular carcinoma, HCC), a disease with a high medical need and only very few treatment options available, is one of the indications currently addressed with resminostat in clinical Phase II trials. Resminostat has recently shown excellent Phase II results in this indication, achieving a median overall survival (OS) of 8.0 months in second-line HCC patients in the combination treatment with sorafenib (Nexavar(R)).

According to the World Health Organization (GLOBOCAN 2008), there were more than 400,000 incidences of liver cancer in China in 2008 - accounting for 14% of all new cases of cancer in this country. The number of new cases of liver cancer per year in China is expected to grow to 550,000 by the year 2020. According to IMS Health, China - with a total volume of 50 bn. USD - is the world's third largest pharmaceutical market behind the USA and Japan. Until 2020, analysts estimate a further growth of this sector in China by 18 to 25% per year. Due to the high occurrence of hepatitis infections, liver cancer has particularly high incidence rates in the whole Asian-Pacific region. 4SC entered into a first development and commercialisation partnership in this growth region in April 2011, when it granted an exclusive license for resminostat to Yakult Honsha, the Japanese market leader for gastrointestinal cancer therapies.

Dr. Ulrich Dauer, Chief Executive Officer of 4SC AG, commented: 'We are very pleased to obtain this key patent for our lead anti-cancer compound resminostat in China. This bolsters our competitive position in this large and attractive market as well as in the whole Asian-Pacific region, which is commercially very important for the development of resminostat in the indication of liver cancer (HCC). After we have recently shown excellent overall survival data in a Phase II trial in patients with advanced HCC, we are currently in talks with regulatory agencies and potential partners to prepare a global registration trial with resminostat in this indication. We believe that the enhanced patent protection in China will serve to further advance the successful progress of these talks with potential partners.'

About Resminostat

Resminostat (4SC-201), 4SC's lead oncology compound, is an oral pan-histone-deacetylase (HDAC) inhibitor with an innovative epigenetic mechanism of action that potentially enables the compound to be deployed as a novel, targeted tumour therapy for a broad spectrum of oncological indications, both as a monotherapy and, in particular, in combination with other cancer drugs. HDAC inhibitors have been shown to modify the DNA structure of tumour cells to cause their differentiation and programmed cell death (apoptosis) and are therefore considered to offer a mechanism of action that has the particular potential to halt tumour progression and induce tumour regression. Additionally, resminostat is also assumed to induce what is known as tumour cell (re-)sensitisation to other anti-cancer compounds. This process can suppress or reverse certain tolerance and resistance mechanisms which tumour cells often develop against other cancer drugs. Supplementary treatment with resminostat can be expected to restore or significantly improve the efficacy of a previously administered cancer therapy which was no longer effective; furthermore, combining resminostat and common cancer drugs right from the very beginning can also be expected to effectively enhance the success of such a treatment.

Resminostat is currently being investigated in a broad clinical Phase II programme in the three indications liver cancer (hepatocellular carcinoma, HCC), Hodgkin's Lymphoma (HL), and colorectal cancer (CRC). In the Phase II SAPHIRE trial in patients with advanced Hodgkin's Lymphoma, resminostat in monotherapy has demonstrated substantial anti-tumour activity, with an overall response rate of 35.3% and a clinical benefit in 55.9% of the patients in a heavily pre-treated patient population together with very good safety and tolerability. In the Phase I/II SHORE study, which evaluates resminostat in combination with the chemotherapeutic FOLFIRI regimen as a second-line treatment of KRAS-mutant CRC patients, initial results are expected in 2012. Furthermore, in the Phase II SHELTER study resminostat is being evaluated as monotherapy and in combination with sorafenib as a second-line treatment in advanced HCC after proven radiological disease progression under first-line sorafenib therapy. Patients receiving the resminostat/sorafenib combination therapy showed a median overall survival of 8.0 months (as reported at the annual meeting of the International Liver Cancer Association (ILCA) on 16 September 2012). As presented at the ASCO annual meeting on 4 June 2012, the resminostat/sorafenib combination therapy had shown a progression-free survival rate (PFSR) after 12 weeks of 70.0% and a median PFS of 4.7 months. The primary study endpoint has been achieved ahead of schedule in both the combination and the monotherapy group.

4SC is currently in discussions with regulatory agencies and potential partners in order to prepare a pivotal clinical study programme for resminostat in combination with sorafenib as a second-line treatment for patients with advanced HCC who show tumour progression on first-line treatment with sorafenib.

Legal Note

This document may contain projections or estimates relating to plans and objectives relating to our future operations, products, or services; future financial results; or assumptions underlying or relating to any such statements; each of which constitutes a forward-looking statement subject to risks and uncertainties, many of which are beyond our control. Actual results could differ materially, depending on a number of factors.

4SC AG

The Group managed by 4SC AG (ISIN DE0005753818) discovers and develops targeted, small-molecule drugs for treating diseases with high unmet medical needs in various autoimmune and cancer indications. These drugs are intended to provide innovative treatment options that are more tolerable and efficacious than existing therapies, and provide a better quality of life. The Company's balanced 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 leading pharmaceutical companies. Founded in 1997, 4SC had 90 employees at 30 June 2012. 4SC AG has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.

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