DGAP-News: European Medicines Agency Adopts Positive Opinion for Orphan Medicinal Product Designation for 4SC's Resminostat to Treat Hepatocellular Carcinoma
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Miscellaneous
European Medicines Agency Adopts Positive Opinion for Orphan Medicinal
Product Designation for 4SC's Resminostat to Treat Hepatocellular
Carcinoma
26.07.2011 / 07:30
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European Medicines Agency Adopts Positive Opinion for Orphan Medicinal
Product Designation for 4SC's Resminostat to Treat Hepatocellular Carcinoma
Planegg-Martinsried, Germany, 26 July, 2011 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune diseases and cancer, today announced that the
European Medicines Agency (EMA) has recommended resminostat for designation
as orphan medicinal product for the treatment of hepatocellular carcinoma
(HCC), the most common form of liver cancer. The EMA's positive opinion has
been forwarded to the EU commission for final approval and publication in
the community register. This follows the recent orphan drug designation
granted by the U.S. Food and Drug Administration for the same programme.
'Recommendation for orphan medicinal product designation in the EU is
another important step in the development of resminostat, our most advanced
oncology compound, as a potential targeted treatment for HCC,' commented
Ulrich Dauer, Chief Executive Officer of 4SC AG. 'Both orphan drug
designations from the EMA as well as from the FDA emphasise the importance
of developing novel therapies in this indication in order to provide
effective treatment options to patients suffering from this
life-threatening disease. We are looking forward to working with both
authorities closely as this programme progresses.'
The EMA's orphan medicinal product designation includes a ten-year period
of market exclusivity from the date of approval for drugs and biologics
that address rare diseases that affect no more than five in 10,000 people
in the European Union. The designation also allows direct access to
centralized marketing authorization, fee reductions and protocol
assistance.
Ends
About Resminostat
Resminostat (4SC-201) is an oral pan-histone-deacetylase (HDAC) inhibitor.
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 particular potential
to halt tumour progression and induce tumour regression. Resminostat is
currently being investigated in the Phase II SHELTER study as a second-line
treatment for advanced hepatocellular carcinoma and a Phase II study, the
SAPHIRE trial, in third-line treatment in Hodgkin's lymphoma. These two
trials are expected to report Phase II results in 2011. In addition, the
Phase I/II SHORE study is evaluating resminostat as a second-line therapy
setting in colorectal cancer in KRAS-mutant patients.
Resminostat is currently partnered in Japan with Yakult Honsha.
About 4SC
4SC (ISIN DE0005753818) discovers and develops targeted small-molecule
drugs for the treatment of diseases with a high unmet medical need in
various autoimmune and cancer indications. These drugs are intended to
provide patients with innovative treatment options that are more tolerable
and efficacious than existing therapies, and provide a better quality of
life. The company's balanced pipeline comprises promising products that are
in various stages of clinical development. 4SC's aim is to generate future
growth and enhance its enterprise value by entering into partnerships with
leading pharmaceutical companies.
Founded in 1997, 4SC currently has 94 employees and has been listed on the
Prime Standard of the Frankfurt Stock Exchange since December 2005.
For further information, please visit www.4sc.com.
Legal Note
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.
For more information please contact:
4SC AG
Bettina v. Klitzing-Stückle, Corporate Communications
Tel.: +49 (0) 89 70 07 63 0
MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 30
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
End of Corporate News
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Language: English
Company: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Germany
Phone: +49 (0)89 7007 63-0
Fax: +49 (0)89 7007 63-29
E-mail: public(at)4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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133069 26.07.2011
Datum: 26.07.2011 - 07:30 Uhr
Sprache: Deutsch
News-ID 34678
Anzahl Zeichen: 0
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Kategorie:
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