Corporate | 5 December 2011 07:30
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4SC AG / Key word(s): Miscellaneous
Press Release 4SC to present results of clinical Phase II study with Resminostat in Hodgkin's Lymphoma at ASH Meeting in San Diego Planegg-Martinsried, Germany, 5 December 2011 – 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 will present results of the clinical Phase II SAPHIRE study with its anti-cancer compound resminostat in patients with Hodgkin's lymphoma (HL) at the 2011 Annual Meeting of the American Society of Hematology (ASH) in San Diego, California. Results will be presented in a poster session to be held on 11 December 2011 at 6 pm (PST). The open-label, single-arm, international study evaluated safety, pharmacokinetics, biomarkers, and efficacy of resminostat monotherapy treatment in, as of today, 34 evaluable patients with advanced HL. Patients enrolled in the trial had either relapsed after high dose chemotherapy and/or autologous stem cell transplantation (ASCT) or had become refractory to treatment, and had on average received 6 prior treatments. An overall response rate (ORR) of 35.3% was observed and more than half (55.9%) of the patients received a clinical benefit from resminostat treatment, suggesting a substantial anti-tumour activity. Furthermore, resminostat showed a very good safety and tolerability profile. Currently one further patient is still under treatment and has achieved stabilization of disease for now 30 weeks. From 11 December 2011, 6 pm (PST) (that is 12 December 2011, 3 am (CET) in Germany), the scientific poster with the detailed study results presented at the ASH meeting can be downloaded from http://www.4sc.de/product-pipeline/publications-posters/resminostat . Ends Details of the Presentation:
Presentation #2675, Title:
'Results of the Phase II SAPHIRE Trial of Resminostat (4SC-201) in Patients with Relapsed/Refractory Hodgkin Lymphoma'
About the SAPHIRE Trial Design The SAPHIRE trial included HL patients that had relapsed after high dose chemotherapy and/or autologous stem cell transplantation (ASCT) or had become refractory to treatment. The study was designed as an open-label, single-arm, international trial consisting of two recruitment stages according to the Simon's Minimax design. Resminostat has been administered orally at a once daily dose of 600 mg during the 1st recruitment stage and due to its good tolerability at a higher daily dose of 800 mg in the 2nd stage. Patients were treated in 14-day cycles of five consecutive days followed by a nine-day treatment-free period (5+9 schedule). Patients underwent assessment of their disease status by computed tomography in combination with positron emission tomography (PET/CT) after Cycle 3 and Cycle 6 and thereafter every fourth cycle during an optional follow-up period in which patients could continue treatment until disease progression. The primary endpoint of the study was defined as the overall objective response rate (ORR) based on the best objective response during treatment. Secondary endpoints include time to response (TTR), duration of response (DOR), progression free survival (PFS), overall survival (OS), safety and tolerability and the evaluation of drug regulated biomarkers including the assessment of TARC levels. About Hodgkin's Lymphoma Hodgkin's Lymphoma (HL) is a cancer of the lymphatic system, which is part of the immune system, and leads to the abnormal growth of lymphatic cells that compromise the immune system's ability to fight infection. The disease can however also spread beyond the lymphatic systems to other organs. The main causes for the development of HL are still unknown. Recent research shows that this tumour originates from a degenerated lymphatic cell, the B lymphocyte. The incidence of HL in 2008 was 11,777 new cases in Europe and 8,220 new cases in the US. The age distribution is bimodal; the first peak occurs between the ages of 15 and 30 years and the second in the seventh decade. HL is curable in the majority of cases. However, not all patients respond to current standard therapy strategies and available treatments for this disease can have significant long-term toxicity. Therapy options for HL patients depend on the stage of the disease and number and regions of lymph nodes affected. The first treatment line for HL, after the initial diagnosis, consists of chemotherapy and/or radiation, achieving cure rates of up to 80%. Standard of care for patients with refractory or relapsing disease after initial therapy consists of a salvage therapy comprising a conventional chemotherapy regimen usually followed by stem cell mobilization and subsequent high-dose chemotherapy along with autologous stem cell transplantation. Patients relapsing after second line therapy have a 5-year overall survival rate of only 17% (Source: Sirohi et al., Ann.Oncol., 2008). Since there is no standard of care in patients with relapsed/refractory HL, there is an especially high need to develop novel therapies for these patients. About Resminostat Resminostat (4SC-201) is an oral pan-histone-deacetylase (HDAC) inhibitor. HDAC inhibitors 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. Resminostat is currently being investigated in the Phase II SHELTER study as a second-line treatment for advanced hepatocellular carcinoma (HCC) and in the Phase I/II SHORE study as a second-line treatment in colorectal cancer in KRAS-mutant patients. The Phase II SHELTER study is expected to report Phase II results in the beginning of 2012. Initial results of the SHORE study are expected in 2012. With an overall response rate of 35.3% and a clinical benefit in 55.9% of the patients, the Phase II SAPHIRE trial with resminostat as a monotherapy in advanced Hodgkin's lymphoma has demonstrated the drug's substantial anti-tumour activity in a heavily pre-treated patient population together with very good safety and tolerability. The study is still ongoing as one further patient is still continuing therapy and has currently achieved stabilization of disease for more than 30 weeks in the optional follow-up phase beyond the study's main treatment part of 12 weeks. About 4SC 4SC (ISIN DE0005753818) discovers and develops targeted small-molecule drugs for the treatment of diseases with a high unmet medical need in various autoimmune and cancer indications. These drugs are intended to provide patients with 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 currently has 94 employees and 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
Bettina v. Klitzing-Stückle, Corporate Communications
MC Services (Europe)
Mareike Mohr
The Trout Group (USA)
End of Corporate News 05.12.2011 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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