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4SC Announces Clinical Advancements in its Oncology Pipeline

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4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, has announced progress in the initiation of three new clinical trials for its oncology franchise:

• Initiation of a Phase II trial with the oral, pan histone deacetylase (HDAC) inhibitor resminostat (4SC-201) for the treatment of relapsed or refractory Hodgkin’s Lymphoma (HL).

• First-in-man Phase I trial for the multi-target kinase inhibitor 4SC-203 open for recruitment.

• Phase I study protocol accepted by BfArM (German Federal Institute for Drugs and Medical Devices) for 4SC-205, an oral inhibitor of Eg5 kinesin.

After the recent initiation of a first Phase II study with resminostat (4SC-201) in hepatocellular carcinoma (HCC) earlier this year, this proof-of-concept study in Hodgkin’s Lymphoma (HL) is the second Phase II trial commenced by 4SC with its pan HDAC inhibitor. This study is a multicentre, international clinical trial expected to enrol 33 relapsed or refractory HL patients in three eastern EU countries. The primary endpoint of the trial is to evaluate the objective overall response rate (ORR), with disease assessment being performed on the basis of computed tomography in combination with positron emission tomography (PET/CT).

Furthermore, the Phase I trial with 4SC-203 is now open for recruitment. The primary endpoint of this randomized, double-blind, placebo-controlled, dose-escalating study in healthy volunteers is to investigate the safety and tolerability of 4SC-203 after single dose administrations. Up to 50 study volunteers will be enrolled in one trial site in Germany. This compound has shown to be an effective inhibitor of leukemic cell proliferation, in particular acute myeloid leukaemia (AML) derived cells. 4SC-203 was co-developed with ProQinase GmbH, Freiburg, Germany.

In addition, the Phase I clinical study protocol for 4SC-205 has been accepted by BfArM. Initiation of enrolment of cancer patients is expected in January 2010. This open-label, doseescalating Phase I trial will recruit up to 30 patients with advanced solid tumors and malignant lymphomas in two study sites in Germany. The primary endpoint will be the evaluation of the safety and tolerability of 4SC-205. This compound is a novel, oral inhibitor of the kinesin-spindle protein Eg5, a motor protein responsible for proper chromosome separation, inhibition of which causes cell death as it arrests the cell cycle, the division and duplication of cells.

Dr Bernd Hentsch, Chief Development Officer of 4SC, commented: “2009 has been a year of great clinical advancements for 4SC. Within our oncology franchise, we have positioned our HDAC inhibitor resminostat (4SC-201) in two Phase II proof-of-concept trials in both solid and haematological cancer indications. In addition, the transfer of 4SC-203 and 4SC-205 into clinical development highlights that we continue to support the further expansion of our pipeline with novel compounds from our proprietary research. Our approach to develop drug candidates in indications with high unmet medical needs has the broad potential to create significant and sustained value for our products, company and patients.”