PLANEGG-MARTINSRIED, Germany--(BUSINESS WIRE)-- 4SC AG (FWB:VSC.f - News), a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, today announced positive topline data from its Phase II SAPHIRE trial with resminostat, its oral pan HDAC inhibitor, in patients with relapsed/refractory Hodgkin's Lymphoma (HL). Resminostat monotherapy exhibited substantial anti-tumour activity, including complete and partial tumour responses. Analysis of tumour response assessments revealed that the study achieved its primary endpoint. Furthermore the study verified the drug to be safe and well tolerated in this advanced stage patient population.
In June 2011 the SAPHIRE trial completed patient enrolment. 33 patients have been evaluated for tumour response which, according to the study protocol, represents the targeted number of patients required for efficacy analyses. Central assessment of patient tumour data by an independent expert review board revealed objective tumour responses in 11 patients, constituting a 33.3% overall response rate (ORR) and thereby successfully achieving the pre-defined requirements of the primary endpoint of the study. An additional 7 patients achieved stabilization of their disease and thus a clinical benefit as well. The ORR of 33.3% together with the clinical benefit recorded in total for 54.5% of the patients (disease control rate) demonstrates the substantial anti-tumour activity of resminostat monotherapy in an advanced and heavily pre-treated Hodgkin's Lymphoma patient population for which there is currently no established standard therapy available. Prior to study entry, the patients enrolled received a median of 6 treatments consisting of various chemo- and radiation therapies including autologous stem cell transplantation in 57% of the cases.
Final data from this trial, including secondary endpoints, will be presented at an upcoming international scientific conference.
Information and Explaination of the Issuer to this News:
Conference Call & Webcast
The senior management team of 4SC will host a conference call and webcast at 3pm CET (9am EST) today to inform about the topline results of the SAPHIRE study.
Access to the presentation slides can be obtained at:
Participants can access the conference under the following telephone numbers:
Date: 6 September, 2011
Time: 3pm CET (9am EST)
0800 10 12 072 (Germany)
0800 358 0886 (UK)
1 877 941 1469 (USA)
+49 (0) 6103 485 3001 (other countries)
Approximately two hours after the live presentation, an audio replay will be available on the 'investors' section of the homepage www.4sc.com.
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.
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 further information, please visit www.4sc.com
Company: 4SC AG
Am Klopferspitz 19a
Phone: +49 (0)89 7007 63-0
Fax: +49 (0)89 7007 63-29
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
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