DGAP-News: FDA grants Orphan Drug Designation to 4SC's Oral Pan-HDAC Inhibitor Resminostat for the Treatment of Hepatocellular Carcinoma
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Miscellaneous
FDA grants Orphan Drug Designation to 4SC's Oral Pan-HDAC Inhibitor
Resminostat for the Treatment of Hepatocellular Carcinoma
12.07.2011 / 07:30
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Planegg-Martinsried, Germany, 12 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
US Food and Drug Administration (FDA) has granted orphan drug designation
to 4SC's lead oncology compound resminostat for the treatment of
hepatocellular cancer (HCC), the most common form of liver cancer.
Resminostat is in Phase II clinical development in advanced HCC, with
results expected towards the end of 2011.
4SC is conducting its HCC SHELTER trial in a second therapy line setting in
advanced HCC patients who prior to entry into this study are progressing
under the only approved systemic first line therapeutic sorafenib. In this
study resminostat is being explored in two study arms, i.e. in monotherapy
and also in a resensitizing approach in combination with sorafenib.
Orphan drug designation is granted by the FDA to promote the development of
products that may offer therapeutic benefits for diseases affecting less
than 200,000 people in the USA. Orphan drug designations are based on
several criteria that include frequency and seriousness of the condition,
the lack of therapies and scientific merit of the proposed medicinal
product and provide opportunities for significant fee and tax reductions
before and after marketing authorization and the opportunity to obtain
seven years of market exclusivity following drug approval, thereby offering
competitive protection from similar drugs of the same class.
Even though HCC qualifies as an orphan drug indication in the USA,
world-wide it represents the sixth most common cancer and the third leading
cause of cancer-related deaths globally, rendering it a major health care
problem. Most cases of HCC are secondary to either viral hepatitis
infection or liver cirrhosis due to alcoholism. HCC has a particularly high
prevalence in South-East Asia, as its cause is linked to high rates of
hepatitis B virus infections present in this region. In North America and
Europe, the incidence of HCC has historically been lower, however, also
there the incidence of this cancer type is growing.
Ulrich Dauer, CEO of 4SC commented 'Our strategy for the development of
resminostat, an oral-HDAC inhibitor, has been to evaluate its mechanism of
action in three cancer indications: hepatocellular carcinoma, Hodgkin's
lymphoma and colorectal cancer. HCC presents a significant commercial
market opportunity for resminostat as there are currently only very limited
treatment options specifically for patients that suffer from advanced
stages of this serious disease. We are excited about this FDA approval of
our application for orphan drug designation which will support the
development and potential future marketing of resminostat in this rare
disease. We are looking forward to finalising results from the ongoing
Phase II SHELTER trial in 2011, from which we have so far announced
encouraging interim data due to its open-label structure.'
For more information please contact:
4SC AG
Yvonne Alexander, IR&PR
Tel.: +49 (0) 89 70 07 63 0
MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
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.
End of Corporate News
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Language: English
Company: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Deutschland
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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131584 12.07.2011
Datum: 12.07.2011 - 07:30 Uhr
Sprache: Deutsch
News-ID 34588
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