DGAP-News: 4SC's Resminostat receives FDA Orphan Drug Status for Hodgkin's Lymphoma
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Miscellaneous
4SC's Resminostat receives FDA Orphan Drug Status for Hodgkin's
Lymphoma
26.09.2011 / 07:30
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4SC's Resminostat receives FDA Orphan Drug Status for Hodgkin's Lymphoma
Planegg-Martinsried, Germany, 26 September, 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 in Hodgkin's lymphoma (HL).
Resminostat was recently granted orphan drug designation by the FDA in
another oncology indication, hepatocellular carcinoma (HCC).
The oral pan HDAC inhibitor resminostat is currently being developed in
three different oncology indications: hepatocellular carcinoma (HCC),
colorectal cancer (CRC) and Hodgkin's Lymphoma (HL). On 6 September, 2011
4SC published positive topline results from its Phase II SAPHIRE study
evaluating resminostat as a third-line treatment in relapsed/refractory HL
patients. The study met its primary endpoint, showing a 33.3% overall
response rate and 54.5% of patients achieving a clinical benefit from the
treatment with resminostat. The final data including secondary endpoints
will be presented at a forthcoming international scientific conference.
Ulrich Dauer, CEO of 4SC commented 'We are very pleased about yet another
orphan drug designation by the FDA for our lead oncology compound
resminostat in Hodgkin's lymphoma shortly after the presentation of
positive topline data from our SAPHIRE study. The combined final data set
of the SAPHIRE study in HL and the SHELTER study in HCC, which is
anticipated by the end of this year, should encourage us to discuss our
plans for a pivotal development programme for resminostat with regulatory
authorities and potential partners in the near future.'
Ends
About Orphan Drug Designation by the FDA
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.
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.
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. 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 and 30 years and the second in the
seventh decade.
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% [1]. 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 two patients are continuing on
study therapy in the optional follow-up phase beyond 12 weeks of treatment.
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.
References
[1] Long-term outcome of ASCT in relapsed or refractory HL (Sirohi et al.,
Ann.Oncol., 2008)
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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