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| Datum : | 06.05.2014 |
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DGAP-News: Press Release: 4SC's partner Yakult Honsha completes Phase I study with resminostat in Japanese patients with solid tumors, 4SC eligible for milestone payment |
| Meldung : | DGAP-News: 4SC AG / Key word(s): Miscellaneous Press Release: 4SC's partner Yakult Honsha completes Phase I study with resminostat in Japanese patients with solid tumors, 4SC eligible for milestone payment 06.05.2014 / 07:30 --------------------------------------------------------------------- Press Release 4SC's partner Yakult Honsha completes Phase I study with resminostat in Japanese patients with solid tumors, 4SC eligible for milestone payment Planegg-Martinsried, Germany, 6 May 2014 - 4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for cancer and autoimmune diseases, today announced that its Japanese partner Yakult Honsha Co., Ltd. has successfully completed a Japan-based Phase I clinical study with 4SC's cancer drug resminostat in patients with solid tumours. The study demonstrated the clean safety profile of resminostat in Japanese cancer patients, which is a key prerequisite of the resminostat's further clinical development in Japan. The successful completion of the study has also triggered a milestone payment from Yakult to 4SC. The open-arm, dose-escalating study evaluated safety and tolerability of resminostat in doses of up to 800 mg Resminostat in 12 Japanese patients with advanced solid tumours. In addition, the drug's pharmacokinetics and pharmacodynamics were investigated. Resminostat proved to be safe and well tolerated in all doses tested. The observed side effects were generally of moderate nature. These results confirm the clean safety profile which resminostat has already shown in several studies in Western patient populations. Yakult Honsha is planning a publication of the detailed results at a scientific conference in summer 2014 as well as submission of the manuscript to a peer-reviewed journal. The development of resminostat in the Japanese market is of high strategic importance to 4SC. In April 2011, 4SC has granted an exclusive license to Yakult Honsha, the Japanese market leader in gastro-intestinal cancer therapeutics, for the development and commercialisation of resminostat in Japan. Yakult is currently investigating resminostat in two Phase I/II studies in Japan, in liver cancer (hepatocellular carcinoma, HCC) and non-small-cell lung cancer (NSCLC). HCC, a cancer with a high medical need and very limited therapeutic options, has a particularly high incidence in Japan. HCC is also the key indication of 4SC's planned development programme with resminostat in the Western world. Enno Spillner, Chief Executive Officer of 4SC, said: "We are very pleased that our partner Yakult Honsha has completed its Phase I study with resminostat, once again confirming the clean safety profile of resminostat, however for the first time also in an Asian patient population. For us, the received milestone payment is both another important valuation of resminostat's great potential and a valuable contribution to 4SC's financing. We are delighted about the great enthusiasm and energy of our Japanese partner in the development of resminostat and we look forward to Yakult's next clinical findings in its ongoing clinical trials in HCC and NSCLC. In parallel, we will continue to drive forward the preparation and financing of our own clinical development plans with resminostat in first-line HCC in the Western world." Ends About Resminostat Resminostat (4SC-201), 4SC's lead oncology compound, is an oral 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 in 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 to date has been investigated in a broad clinical campaign comprising liver cancer (hepatocellular carcinoma, HCC), Hodgkin's Lymphoma (HL), colorectal cancer (CRC), with non-small-cell lung cancer (NSCLC) recently been added as a fourth cancer indication to the programme. In the Phase II SAPHIRE trial in patients with advanced Hodgkin's Lymphoma (HL), resminostat in monotherapy has demonstrated anti-tumour activity, with an overall response rate of 34% and a clinical benefit in 54% of the patients in a heavily pre-treated patient population together with very good safety and tolerability. In the Phase IIa SHELTER study resminostat has been 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 8.1 months. The resminostat/sorafenib combination therapy had shown a progression-free survival rate (PFSR) after 12 weeks of 70.0% and a median PFS of 5.4 months. Notably, in both tumour indications, HCC and HL, gene expression levels of the new biomarker ZFP64 measured prior to study treatment start in blood cells of patients, were identified to be indicative of survival outcome upon treatment with resminostat. Hereby, patients with a high level of ZFP64 gene expression at baseline experienced a doubling of overall survival compared with patients with low ZFP64 expression levels. Resminostat was further studied in a Phase I dose escalation approach in advanced colorectal cancer (CRC) patients evaluating resminostat in combination with the standard chemotherapeutic FOLFIRI regimen. Positive results for safety and tolerability as well as promising signs of clinical activity of this combination were published at the 2013 ASCO conference. 4SC is currently in preparation of the next development step of developing resminostat towards market approval in first-line HCC, a randomised-controlled, double-blind Phase II study evaluating the resminostat sorafenib combination compared to the current treatment standard sorafenib, as a first line treatment of advanced HCC. 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 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 cancer and autoimmune 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 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 and biotech companies. Founded in 1997, 4SC had a headcount of 64 employees (55 FTEs) at 31 March 2014. 4SC AG has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005. Cautionary statement regarding forward-looking statements This press release contains certain forward-looking statements. Any forward-looking statement applies only on the date of this press release. By their nature, forward-looking statements are subject to a number of known and unknown risks and uncertainties that may or may not occur in the future and as a result of which the actual results and performance may differ substantially from the expected future results or performance expressed or implied in the forward looking statements. No warranties or representations are made as to the accuracy, achievement or reasonableness of such statements, estimates or projections, and 4SC AG has no obligation to update any such information or to correct any inaccuracies herein or omission herefrom which may become apparent. For more information please visit www.4sc.com or contact: 4SC AG Jochen Orlowski, Corporate Communications & Investor Relations jochen.orlowski(at)4sc.com, Tel.: +49-89-7007-6366 MC Services Katja Arnold, Michelle Kremer katja.arnold(at)mc-services.eu, Tel.: +49-89-2102-2840 The Trout Group Chad Rubin crubin(at)troutgroup.com, Tel.: +1-646-378-2947 End of Corporate News --------------------------------------------------------------------- 06.05.2014 Dissemination of a Corporate News, transmitted by DGAP - a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. --------------------------------------------------------------------- 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 --------------------------------------------------------------------- 266440 06.05.2014 |
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