- Pressemitteilung BoxID 141944
4SC Announces Start of Dosing in First-in-Man Phase I Study with 4SC-203
This randomised, 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 randomised 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 (the growth of new blood vessels necessary for progression of solid tumours). This compound was co-developed with ProQinase GmbH, Freiburg, Germany (www.proqinase.com).
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 tumour diseases. "
More information about this trial can be found on www.clinicaltrials.gov.
4SC-203 is a novel multi-target kinase inhibitor. In preclinical testing the compound has shown unique and strong selectivity against a set of kinases including FLT3, FLT3 mutants and VEGF-receptors. This target activity profile holds particular promise since FLT3 is regarded as a specifically important cancer target in AML. Generally, FLT3 is involved in the growth and maturation of normal blood cells, however, in AML patients this kinase frequently gets overexpressed or activated by mutation, causing uncontrolled cell growth and this way contributes to the progression to cancer. With the additional inhibition of VEGF receptor tyrosine kinases, 4SC-203 may also inhibit angiogenic processes and could therefore also be applicable for the therapy of solid cancer types.
Acute myeloid leukaemia (AML), also known as acute myelogenous leukaemia, is the most common leukemic cancer affecting adults. It is a fast-growing disease characterised by the abnormal growth of a type of white, myeloid, blood cell in bone marrow which hinders the development of normal blood cells. The symptoms of the disease include fatigue, easy bruising, bleeding and increased risk of infection. AML causes approximately 1.2% of cancer deaths in the USA; however it is increasing due to the ageing population. The treatment of this disease is categorised into three stages: induction, post remission and post relapse therapy. Treatment is initially and subsequently chemotherapy, eventually combined or followed by hematopoietic stem cell transplantation. Although remission can be induced in most patients, only approximately one third of patients survive more than five years.
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.
4SC AG (ISIN DE0005753818) is a small molecule drug discovery and development company focused on autoimmune and cancer indications. 4SC-101, a DHODH and IL-17 inhibitor, is currently in a Phase IIb study in rheumatoid arthritis and a Phase IIa exploratory study in inflammatory bowel disease. 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. 4SC-203, a multi-kinase inhbitor is in a Phase I study. 4SC-205, a further oncology compound, is due to commence a Phase I study shortly. 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.
4SC was founded in 1997, has 93 employees, and is listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
For further information please visit www.4sc.com.
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