4SC AG
Press Release: 4SC’s partner Yakult Honsha enters with cancer compound resminostat further indications and starts clinical Phase I study in patients with pancreatic or biliary tract cancer in Japan
4SC AG / Key word(s): Study Press Release 4SC’s partner Yakult Honsha enters with cancer compound resminostat further indications and starts clinical Phase I study in patients with pancreatic or biliary tract cancer in Japan — Safety, tolerability and efficacy of resminostat in combination with S-1 chemotherapy will be investigated in various dosing schemes in order to determine dose regimen for potential subsequent Phase II trials in advanced pancreatic and/or biliary tract cancer. — Planegg-Martinsried, Germany, 26 June 2015 – 4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for cancer and autoimmune diseases, today announced that the first patient has been treated with resminostat in a Japan-based Phase I clinical study conducted by 4SC’s exclusive Japanese partner Yakult Honsha. The multi-centre open-label study will investigate safety, pharmacokinetics, biomarkers and efficacy of various dose regimens of resminostat in monotherapy or in combination with the S-1 chemotherapy in up to 44 Japanese patients with advanced pancreatic or biliary tract cancer. The main goal of the study is to determine the recommended regimen for subsequent Phase II trials in these indications. In Part 1 of the study, dose limiting toxicities (DLTs) of various dose regimens of resminostat in monotherapy and the resminostat/S-1 combination therapy will be determined in up to 24 patients. In Part 2, the tolerability and safety of the regimen/s selected in Part 1 will be further evaluated in 20 additional patients in order to determine the recommended regimen/s for subsequent Phase II studies. Furthermore, the study will investigate pharmacokinetics, biomarkers and efficacy criteria including best overall response, progression-free survival (PFS), and overall survival (OS). The overall development rationale behind the study is to test the epigenetic agent resminostat in further gastrointestinal indications and in particular in combination with the S-1 chemotherapy, which is approved for the treatment of pancreatic and biliary tract cancer in Japan. S-1 contains a prodrug of the chemotherapeutic agent 5-FU. Resminostat has already been tested clinically in a Phase I study in combination with the 5-FU-based FOLFIRI chemotherapy regimen in Western patients with colorectal cancer. The administration of resminostat in combination with the standard FOLFIRI regimen was well tolerated without any dose limiting toxicity. Moreover in preclinical models, resminostat has shown first positive results in pancreatic and biliary tract cancer. Enno Spillner, Chief Executive Officer of 4SC AG, said: “We very much appreciate that our partner Yakult Honsha has started developing resminostat in combination therapy with an established cancer drug in additional two gastrointestinal solid cancer indications in Japan. There is high unmet medical need in both pancreatic and biliary tract cancer. These new indications are a perfect match to the ongoing Phase II trials by Yakult investigating resminostat in combination therapies in the indications liver cancer (HCC) and non-small-cell lung cancer (NSCLC). While Yakult is evaluating resminostat in a number of mostly gastrointestinal solid cancer indications in Asian patients, 4SC intends to focus, as the immediate next step, on developing resminostat in the heamatological indication of CTCL in Europe where we also see a high medical need and an attractive opportunity for a fast-to-market option for resminostat. We are currently preparing a European Phase II study in CTCL.” Release Ends About pancreatic cancer and biliary tract cancer Primary bile duct cancer is a relatively rare cancer, however, with the number of new cases increasing. In Japan, the incidence of biliary tract cancer and intrahepatic bile duct cancer is about 10 out of every 100,000 people, which is higher than the incidences in other countries. These cancers typically have a poor prognosis, with 5-year survival rates in the range of 5% to 15%. In Japan, chemotherapies gemcitabine, cisplatin and S-1 have been used in this indication. About resminostat Resminostat – by 4SC and its Japanese partner Yakult – has been investigated in a broad clinical campaign comprising liver cancer (hepatocellular carcinoma, HCC), Hodgkin’s Lymphoma (HL), colorectal cancer (CRC), and non-small-cell lung cancer (NSCLC). In the Phase II SAPHIRE trial in patients with advanced Hodgkin’s Lymphoma (HL), resminostat 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 Western HCC patients 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 and a progression-free survival rate (PFSR) after 12 weeks of 62.5% and a median time-to-progression (TTP) of 6.5 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 potentially indicative of survival outcome upon treatment with resminostat. Hereby, the set of patients with a high level of ZFP64 gene expression at baseline showed a statistically significant increase of median 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. Yakult Honsha is currently developing resminiostat in two randomised clinical Phase II trials in Asian patients in HCC and NSCLC and in a Phase I trial in patients with pancreatic and biliary tract cancer. Resminostat is partnered with Yakult Honsha for Japan and with Menarini in the Asia Pacific (APAC) region excluding Japan. 4SC is currently in preparations of a randomised, controlled Phase II trial in the indication of advanced cutaneous T-cell lymphoma (CTCL) in Europe. About the resminostat partnering agreement with Yakult Honsha for Japan About 4SC Cautionary statement regarding forward-looking statements For more information please visit www.4sc.com or contact: 4SC AG MC Services 2015-06-26 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. 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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: | DE000A14KL72 | |
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