Dose finding in Phase-I trial for 4SC-201 successfully concluded

(PresseBox) (Planegg-Martinsried, ) The Martinsried-based drug discovery and development company 4SC AG (Frankfurt, Prime Standard: VSC) announced today that the last patient had been included in the phase-I clinical trial with drug candidate 4SC-201 and had already tolerated the first two cycles of treatment with a daily dose of 800 mg well. Since no dose-limiting toxicity occurred, patient recruitment for this phase-I test series as well as the clinical dose finding for future phase-II trials based upon it were concluded.

4SC-201 is a drug candidate from the class of histone deacetylase (HDAC) inhibitors, which 4SC AG is developing for the treatment of cancer. In the phase-I clinical trial with this drug candidate, a total of 18 cancer patients were treated. On the one hand, the objective of the study is to evaluate safety, tolerability and pharmacokinetics as well as, on the other hand, determine the maximum tolerated dose and dose-limiting toxicity and examine the pharmacodynamics and therapeutic efficacy of 4SC-201.

The first available study results prove that 4SC-201 can be safely administered orally, is highly tolerated and shows a particularly positive pharmacological profile. To date, in several patients with different tumour types a disease stabilisation has been observed. Two patients in particular who continued treatment with 4SC-201 in an optional subsequent therapy setting that went beyond the main study treatment and which is still ongoing, were already able to reach a total therapy duration of up to eight months, accompanied by a stabilisation of the cancer. The final evaluation of all data collected from this study is planned for the first quarter of 2009.

'We are very pleased that the last patient included in the study also tolerated the treatment with 4SC-201 well and that we can thus reconfirm the results published in October,' said Dr Bernd Hentsch, Chief Development Officer at 4SC AG. 'The evaluation of the data from this phase-I trial will make it possible for us to derive the doses for the further development of 4SC-201. We are now in a position to substantiate and implement our phase-II trial plans with this drug.'

4SC AG plans to start a phase-II clinical trial in a selected indication of solid tumours in the first half of 2009.

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4SC AG

4SC AG (ISIN DE0005753818) has been listed in the Prime Standard of Frankfurt Stock Exchange since 15 December 2005. Founded in 1997 and now with a staff of 83 employees, the company develops novel drug candidates against inflammatory diseases and cancer. 4SC AG utilises its patent protected platform, to create a sustainable project pipeline of drug candidates, which are to be developed up to clinical efficacy in early clinical phases ('proof of concept') and subsequently partnered with the pharmaceutical industry in return for advance and milestone payments as well as royalties. There are currently eight projects in the development pipeline and a rich pool of further discovery projects. Clinical phase IIa for the first project for the treatment of rheumatoid arthritis has already successfully been completed. An additional project for the treatment of various cancers is near completion of a clinical phase I trial. Further projects are in advanced pre-clinical stages. Further information is to be found at www.4sc.com.

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