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52nd ASH Annual Meeting Presentation of Initial Phase II Data from the Saphire Hodgkin's Lymphoma Trial with Resminostat

PLANEGG-MARTINSRIED, Germany--(BUSINESS WIRE)--Dec 1, 2010 - 4SC (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, today announced that initial safety and efficacy data from its ongoing Phase II Study with resminostat, a pan-Histone Deacetylase (HDAC) Inhibitor, in relapsed/refractory Hodgkin Lymphoma (HL) patients after high dose chemotherapy and autologous hematopoietic stem cell transplantation will be presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida, USA.

The data presented include the safety and efficacy results from the first 18 patients from this single-arm, Simon two-stage-design study, that were included in the 1st Simon stage cohort of this trial. These patients received a once daily oral dose of 600 mg resminostat, administered in two week cycles, each consisting of five consecutive therapy days and a nine day treatment free period. Clinical activity was measured through PET/CT, the combination of computer tomography (CT) and positron-emission tomography (PET).

Based on this disease assessment, 10 patients out of those 18 included in this 1st Simon stage cohort benefited from treatment with resminostat. Two of those 10 patients were assessed as partial responders (PR, i.e. more than 50% reduction in size of tumour lesions) and eight patients with stabilization of disease (SD). The PET analysis also revealed that almost all of the patients showed a diminished metabolic activity of their disease lesions, with the majority being evaluated as partial metabolic responders (PMR), i.e., more than 25% decrease in PET activity.

The study treatment with resminostat was well tolerated with primarily mild to moderate gastrointestinal and haematological side effects. Based on these data, the study has recently entered into the 2nd Simon stage recruitment phase and will now also include an optional increase of the daily dose of resminostat from 600 mg to 800 mg.

The study tumour assessments are conducted after cycle 3 and cycle 6, and thereafter every 4th cycle during an optional follow-up treatment period, in which patients may remain on treatment until disease progression or occurrence of intolerance to protocol therapy. The primary endpoint of the study is the estimation of overall objective response rate (OOR), secondary endpoints include time to response (TTR), duration of response (DOR), safety and tolerability and the analysis of drug regulated biomarkers.

Poster Presentation by 4SC:

Abstract: #30077

Poster Board: #II-691

Title: Resminostat In Relapsed or Refractory Hodgkin Lymphoma: Initial Results of the SAPHIRE Phase II Trial with a Novel Oral Histone Deacetylase (HDAC) Inhibitor

Session date and time: 5 December 2010, 6:00 PM - 8:00 PM, Poster session on ' Lymphoma - Chemotherapy, excluding Pre-Clinical Models: Poster II'

Poster Presenter: Jan Walewski, MD, PhD, DSc, Ewa Paszkiewicz-Kozik, MD, Gabriela Borsaru, MD, Andreea Moicean, MD, Agnieszka Warszewska, MD, Klaus Strobel, MD, Alberto Biggi, MD, Bernhard Hauns, MD, Anna Mais, PhD, MSc, Stefan W. Henning, PhD, MSc and Bernd Hentsch, PhD

- End -

About Resminostat (4SC-201)
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 potential to halt tumour progression and induce tumour regression. Resminostat is currently in a Phase II study as a second line treatment for advanced hepatocellular carcinoma and as a third-line treatment in Hodgkin's lymphoma. In a completed Phase I trial in patients with various different cancer types, stable disease was achieved in over 50% of the patients, whilst the treatment was well tolerated and showed a positive, differentiating pharmacological profile to other drugs in this class.

About Hodgkin's Lymphoma
Hodgkin's Lymphoma (HL) - formerly known as Hodgkin's Disease - is a cancer of the lymphatic system, which is part of the immune system. The disease is characterised by the prevalence of the Reed-Sternberg cell. In this disease lymphatic cells grow abnormally and then spread beyond the lymphatic system, which eventually compromises the immune system's ability to fight infection. HL represents one main type of cancer of the lymphatic system. Another type, the class of non-Hodgkin's lymphomas, is more common. Symptoms of HL include the painless swellings of the lymph nodes, spleen or other tissue, as well as fever, weight loss or night sweats.

Therapy options for HL depend on the stage of the disease and number and regions of lymph nodes affected. The first line treatment of 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 comprises salvage chemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation. Disease progression is monitored by computed tomography (CT) in combination with magnetic resonance imaging (MRI) or positron emission tomography (PET). In particular the recent incorporation of functional imaging with PET scanning into disease evaluation has provided significant additional information on the outcome of patients with relapsed HL. For patients exhibiting a complete response after salvage chemotherapy, 5 year progression free survival (PFS) is 79%, but this number drops to 59% for patients only exhibiting partial responses and drops further to 17% for patients resistant to second line therapy regimens. Since there is no standard of care in patients with resistant/refractory HL, there is an especially high need to develop novel therapies for these patients.

About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development company focused on autoimmune and cancer indications. Vidofludimus (4SC-101), a small molecule, is currently in Phase II development in rheumatoid arthritis and inflammatory bowel disease (IBD), for which positive results from a Phase IIa study were recently reported. The company's lead oncology compound, resminostat (4SC-201), a pan-histone deacetylase (HDAC) inhibitor, is in Phase II trials in hepatocellular carcinoma and Hodgkin's lymphoma. Two further oncology compounds, 4SC-203 and 4SC-205, are in Phase I studies. 4SC develops drug candidates until proof-of-concept in order to generate value creating partnerships with the pharmaceutical industry in return for advance and milestone payments as well as royalties.

Founded in 1997, 4SC has 94 employees and has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.

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Posted: December 2010

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