- Pressemitteilung BoxID 122742
4SC presents clinical and preclinical data on its histone deacetylase (HDAC) inhibitor 4SC-201 at the ECCO - ESMO Cancer Conference
The presented anti-tumour cell activity data of 4SC-201, generated in an 18 patient, multiple cancer Phase I trial in at the Royal Marsden Hospital in Sutton, UK, under the supervision of Prof. Dr. J. De Bono, will also focus on the treatment of hepatocellular carcinoma (HCC). Overall, 4SC-201 shows anti-tumor cell activity in the low to sub micromolar range on a broad variety of cancer cells of different solid cancer origins. Furthermore, its anti-cancer activity on liver cancer cells is comparable to the anti-cancer cell activity obtained with sorafenib (Nexavar®, the current standard of care in advanced HCC). Most importantly, when 4SC-201 is combined with sorafenib, both drugs elicit synergistic anti-tumor cell activity, paving the way for also testing this combination therapy in the ongoing clinical HCC trial. HCC represents the first selected cancer indication for this HDAC-inhibitor, which recently commenced the clinical Phase II "Shelter" study, which examines whether second line treatment with 4SC-201 alone or in combination with sorafenib, can induce progression free survival and tumour responses in HCC patients who display progressive disease under treatment with sorafenib. This two-arm, proof-of-concept study in 30-50 patients will be performed at oncology-experienced University hospitals (Tübingen, Heidelberg, Mainz, Halle, Munich) in Germany.
Details of the ECCO poster presentation:
Abstract: No. 1255
Clinical and preclinical development of 4SC-201, a new oral histone deacetylase inhibitor
Session date and time: 21 September, 2009, 09:00am to 12:00pm
Session place: Exhibition Hall 14.1, ICC Berlin (International Congress Center Berlin)
Session title: Drug development - Phase I and Phase II
Session type: Poster Discussion
Poster presenter: Prof. Dr. Johan de Bono (Principal Investigator of the Phase I)
4SC-201 is a novel, oral histone deacetylase (HDAC) inhibitor, for which recently the INN "resminostat" has been proposed by the WHO. 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 in order to move towards the therapeutic control of the cancer diseases. In a Phase I trial in multiple cancers, stable disease was achieved in over 50% of the patients, whilst the compound was well tolerated and showed a positive, differentiating pharmacological profile to other drugs in this class. A Phase II trial investigating 4SC-201 in patients with hepatocellular carcinoma is currently recruiting patients and a further Phase II trial in Hodgkin's Lymphoma is planned later this year.
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 drug discovery and development company focused on autoimmune and cancer indications. The company currently has three clinical programs, with three further clinical trials planned to commence in 2009. The lead autoimmune compound, 4SC-101, is in a Phase IIa trial in Crohn's disease and is due to commence a Phase IIb trial in rheumatoid arthritis in 2009. The lead oncology compound, 4SC-201, is in a Phase II trial in hepatocellular carcinoma (HCC) and is due to commence a further Phase II trial in Hodgkin's lymphoma in 2009. Drug candidates are developed until proof-of-concept and subsequently partnered with the pharmaceutical industry in return for advance and milestone payments as well as royalties. 4SC was founded in 1997, has 92 employees, and is listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
Further information, please visit www.4sc.com.
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