Corporate | 15 May 2012 07:30
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4SC AG / Key word(s): Miscellaneous
Press Release 4SC's partner Yakult Honsha starts clinical development with cancer compound resminostat in Japan
– The Phase I study will assess safety of resminostat in Japanese patients, which is a prerequisite of the drug's further late-stage clinical development in Japan
Planegg-Martinsried, Germany, 15 May 2012 – 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 first patient has been treated in a Japan-based Phase I clinical study with 4SC's cancer drug resminostat. The open-arm, dose-escalating study is being conducted by Yakult Honsha, 4SC's Japanese co-development and marketing partner. The study will evaluate safety and tolerability of resminostat in Japanese patients with advanced solid tumours. It will furthermore investigate the drug's efficacy, pharmacokinetics and pharmacodynamics. The development of resminostat in the Japanese market is of high strategic importance to 4SC for two reasons. In April 2011, 4SC granted an exclusive license to Yakult Honsha, the Japanese market leader in gastro-intestinal cancer therapeutics, for the development and commercialization of resminostat in Japan. Hepatocellular carcinoma (HCC), the most common type of liver cancer with a high medical need and only few available therapeutic options has a particularly high incidence in Japan. HCC is one of the cancer indications targeted with resminostat in advanced clinical development. Dr. Ulrich Dauer, Chief Executive Officer of 4SC AG, said: 'We are very pleased that our Japanese partner Yakult Honsha has started the clinical development of resminostat in Japan. This is of high relevance for both our alliance with Yakult in Japan and the further development strategy for resminostat in this important market. The primary goal of the study is to prove that the drug is safe and well tolerated in Japanese patients, which is a key prerequisite for resminostat's further development in this region. We are currently in discussions with regulatory authorities and potential partners to prepare for a global pivotal clinical study programme with resminostat in patients with advanced liver cancer (HCC). Given the high incidence of HCC in Japan and the whole of Asia, gaining market approval in this region is a key goal for us.' Ends
Resminostat (4SC-201), 4SC's lead oncology compound, is an oral pan-histone-deacetylase (HDAC) inhibitor with an innovative epigenetic mechanism of action that is expected to enable the compound to be deployed as a novel, targeted tumour therapy for a broad spectrum of oncological indications, both as a monotherapy and 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 'sensitisation'. This process can suppress or reverse certain tolerance and resistance mechanisms which tumour cells often develop against other cancer drugs. Accordingly, supplementary treatment with resminostat may thus restore – or significantly improve – the efficacy of an initial cancer therapy. 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. 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 disease progression under first-line sorafenib therapy. According to the data presented at the ASCO-GI annual meeting in January 2012, the primary study endpoint has been achieved ahead of schedule in both therapy arms showing a progression-free survival rate (PFSR) after 12 weeks of 66.6% for the combination therapy group and of 33.3% for 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. HCC is the most frequent form of liver cancer, the fifth most common cancer worldwide and, with approximately 700,000 deaths annually, the third most deadly. The kinase inhibitor sorafenib is currently the only drug approved in first-line therapy of advanced HCC. No approved treatment option is available for patients who become refractory or intolerant to sorafenib treatment (second-line therapy). About the Resminostat Partnering Deal with Yakult Honsha for Japan 4SC granted an exclusive license to Yakult Honsha for the development and commercialization of resminostat in Japan in April 2011. 4SC has received an upfront payment from Yakult Honsha of EUR6 million and is eligible for up to EUR127 million payable upon achieving specified milestones including clinical and regulatory events in Japan. In addition to milestone payments, Yakult will pay 4SC double-digit royalties linked to product sales of resminostat. Yakult Honsha will be responsible for all clinical requirements for resminostat development in Japan in HCC, CRC and other chosen oncology indications. 4SC is aiming to partner this compound in other territories, including Europe, the USA and Asia. About 4SC 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 31 March 2012. 4SC AG has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005. 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. For more information please visit www.4sc.com or contact:
4SC AG
MC Services
Mareike Mohr
The Trout Group (USA)
End of Corporate News 15.05.2012 Dissemination of a Corporate News, transmitted by DGAP – a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. DGAP’s Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de |
| Language: | English | |
| Company: | 4SC AG | |
| Am Klopferspitz 19a | ||
| 82152 Martinsried | ||
| Germany | ||
| Phone: | +49 (0)89 7007 63-0 | |
| Fax: | +49 (0)89 7007 63-29 | |
| E-mail: | public@4sc.com | |
| Internet: | www.4sc.de | |
| ISIN: | DE0005753818 | |
| WKN: | 575381 | |
| Listed: | Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart | |
| End of News | DGAP News-Service |
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