DGAP-News: 4SC's anti-cancer compound Resminostat receives positive opinion for orphan medicinal product designation in Europe to treat Hodgkin's Lymphoma
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Miscellaneous
4SC's anti-cancer compound Resminostat receives positive opinion for
orphan medicinal product designation in Europe to treat Hodgkin's
Lymphoma
13.10.2011 / 07:30
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4SC's anti-cancer compound Resminostat receives positive opinion for orphan
medicinal product designation in Europe to treat Hodgkin's Lymphoma
Planegg-Martinsried, Germany, 13 October 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 4SC's anti-cancer compound
resminostat for designation as orphan medicinal product for the treatment
of Hodgkin's Lymphoma (HL), a cancer of the lymphatic system. EMA's orphan
medicinal product designation includes a ten-year period of market
exclusivity from the date of approval in the European Union (EU) and allows
direct access to a centralized marketing authorization and fee reductions.
Resminostat, 4SC's lead oncologic compound, already received in July 2011 a
positive opinion for orphan medicinal product designation in the EU in the
indication hepatocellular carcinoma (HCC), the most common type of liver
cancer. Furthermore, resminostat recently obtained orphan drug status in
the US for HCC and HL.
As recently reported, in the Phase II SAPHIRE study as a third-line
treatment in relapsed/refractory HL patients, resminostat showed a 33.3%
overall response rate and a general clinical benefit in 54.5% of patients,
demonstrating positive anti-tumour-efficacy and very good tolerability.
Furthermore 4SC had published in June 2011 positive interim data from its
Phase II SHELTER study with resminostat in HCC patients. The oral pan HDAC
inhibitor resminostat is, in addition to evaluation in HL and HCC,
currently also being studied in a phase I/II trial in patients with
colorectal cancer (CRC).
Dr. Ulrich Dauer, CEO of 4SC commented: 'We are delighted that the EMA has
recommended our lead oncology compound resminostat for designation as
orphan medicinal product also in Hodgkin's Lymphoma (HL). Based on the
positive data from our Phase II SAPHIRE study in HL and on the results of
our Phase II SHELTER study in HCC, which are anticipated by the end of this
year, we plan to discuss the next development steps with regulatory
authorities and potential partners. Consequently we expect the next step to
be the planning of a pivotal development programme, especially considering
the high medical need and the limited therapeutic options available in the
indications addressed with resminostat.'
Ends
About Hodgkin's Lymphoma
Hodgkin's Lymphoma (HL) is a cancer of the lymphatic system, which is part
of the immune system, and leads to the abnormal growth of lymphatic cells
that compromise the immune system's ability to fight infection. The disease
can spread beyond the lymphatic systems to other organs. The main causes
for the development of HL are still unknown. Recent research shows that
this tumour has its origin from a degenerated lymphatic cell, the B
lymphocyte. The incidence of HL in 2008 was 11,777 new cases in Europe and
8,220 new cases in the US. The age distribution is bimodal; the first peak
occurs between the ages of 15 and30 years and the second in the seventh
decade.
HL is curable in the majority of cases. However, not all patients can be
cured and available therapies for this disease can have significant
long-term toxicity. Therapy options for HL patients depend on the stage of
the disease and number and regions of lymph nodes affected. The first
treatment line for HL, after the initial diagnosis, consists of
chemotherapy and/or radiation, achieving cure rates of up to 80%. Standard
of care for patients with refractory or relapsing disease after initial
therapy consists of a salvage therapy comprising a conventional
chemotherapy regimen usually followed by stem cell mobilization and
subsequent high-dose chemotherapy along with autologous stem cell
transplantation. Patients relapsing after second line therapy have a 5-year
overall survival rate of only 17% (Source: Sirohi et al., Ann.Oncol.,
2008). Since there is no standard of care in patients with
relapsed/refractory HL, there is an especially high need to develop novel
therapies for these patients.
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 in the Phase I/II SHORE
study as a second-line treatment in colorectal cancer in KRAS-mutant
patients. The SHELTER study is expected to report Phase II results in 2011.
Initial results of the SHORE study are expected in 2012. The reported Phase
II SAPHIRE trial for resminostat as a third-line therapy in Hodgkin's
lymphoma is still ongoing as patients are continuing on study therapy in
the optional follow-up phase beyond the study's main treatment cycle of 12
weeks. 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.
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 further information, please visit www.4sc.com or contact:
4SC AG
Jochen Orlowski, Investor Relations&Public Relations
jochen.orlowski(at)4sc.com
Tel.: +49 (0) 89 70 07 63 0
Bettina v. Klitzing-Stückle, Corporate Communications
bettina.von.klitzing(at)4sc.com
Tel.: +49 (0) 89 70 07 63 0
MC Services (Europe)
Raimund Gabriel
raimund.gabriel(at)mc-services.eu
Tel.: +49 (0) 89 21 02 28 30
Mareike Mohr
mareike.mohr(at)mc-services.eu
Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Chad Rubin
Crubin(at)troutgroup.com
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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