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4SC Announces Start of Dosing in First-in-Man Phase I Study with 4SC-203

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4SC AG has announced the start of dosing in a First-in-Man Phase I study in healthy volunteers evaluating 4SC-203, a novel multi-target kinase inhibitor, with particular specificity against selected kinases, including FMS-like tyrosine kinase 3 (FLT3), FLT3 mutants and vascular endothelial growth factor receptors (VEGF-R).

This randomized, double-blind, placebo-controlled, dose-escalation study investigates the safety, tolerability, pharmacokinetics and pharmacodynamics of 4SC-203, administered as single dose intravenously, in 50 volunteers and comprises seven treatment cohorts.

In the first cohort, an initial low dose of 4SC-203 has been applied for safety observations. Subsequent dose escalating cohorts will include eight volunteers each randomized at a 4SC-203 to placebo ratio of 6:2. The trial is expected to last for approximately six months and to report results in 2010.

4SC-203 is a multi-target kinase inhibitor which has a unique selectivity profile against FLT3, FLT3 mutants and VEGF-Receptors in both in vitro and in vivo studies. FLT3 represents an attractive therapeutic target in acute myeloid leukaemia (AML), as this kinase is over-expressed in patients with this disease.

Furthermore, FLT3 mutations can be identified in approximately one third of these patients, which are associated with a dismal prognosis due to a high relapse rate, for which there currently is no treatment option. In addition, as 4SC-203 has been shown to inhibit vascular endothelial growth factor receptors (VEGF-R) which are responsible for stimulating the cellular responses required for angiogenesis. This compound was co-developed with ProQinase GmbH, Freiburg, Germany.

Dr Bernd Hentsch, Chief Development Officer of 4SC commented: "The commencement of this first-in-man Phase I trial with 4SC-203 which was developed by 4SC from discovery through to development, highlights our ability to build a broad and diversified pipeline. Our oncology development strategy remains to address unmet medical needs and market opportunities by identifying and progressing multiple drug candidates into the clinic that offer different molecular approaches and mode-of-actions, and that may therefore be applicable for a broader range of different tumor diseases."