DGAP-News: 4SC AG: 52nd ASH Annual Meeting Presentation of Initial Phase II Data from the Saphire Hodgkin's Lymphoma Trial with Resminostat
(firmenpresse) - 4SC AG / Key word(s): Miscellaneous
01.12.2010 07:30
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Planegg-Martinsried, Germany, 1 December, 2010 - 4SC (Frankfurt, Prime
Standard: VSC), a drug discovery and development company focused on
autoimmune and cancer indications, today announced that initial safety and
efficacy data from its ongoing Phase II Study with resminostat, a
pan-Histone Deacetylase (HDAC) Inhibitor, in relapsed/refractory Hodgkin
Lymphoma (HL) patients after high dose chemotherapy and autologous
hematopoietic stem cell transplantation will be presented at the 52nd
Annual Meeting of the American Society of Hematology (ASH) in Orlando,
Florida, USA.
The data presented include the safety and efficacy results from the first
18 patients from this single-arm, Simon two-stage-design study, that were
included in the 1st Simon stage cohort of this trial. These patients
received a once daily oral dose of 600 mg resminostat, administered in two
week cycles, each consisting of five consecutive therapy days and a nine
day treatment free period. Clinical activity was measured through PET/CT,
the combination of computer tomography (CT) and positron-emission
tomography (PET).
Based on this disease assessment, 10 patients out of those 18 included in
this 1st Simon stage cohort benefited from treatment with resminostat. Two
of those 10 patients were assessed as partial responders (PR, i.e. more
than 50% reduction in size of tumour lesions) and eight patients with
stabilization of disease (SD). The PET analysis also revealed that almost
all of the patients showed a diminished metabolic activity of their disease
lesions, with the majority being evaluated as partial metabolic responders
(PMR), i.e., more than 25% decrease in PET activity.
The study treatment with resminostat was well tolerated with primarily mild
to moderate gastrointestinal and haematological side effects. Based on
these data, the study has recently entered into the 2nd Simon stage
recruitment phase and will now also include an optional increase of the
daily dose of resminostat from 600 mg to 800 mg.
The study tumour assessments are conducted after cycle 3 and cycle 6, and
thereafter every 4th cycle during an optional follow-up treatment period,
in which patients may remain on treatment until disease progression or
occurrence of intolerance to protocol therapy. The primary endpoint of the
study is the estimation of overall objective response rate (OOR), secondary
endpoints include time to response (TTR), duration of response (DOR),
safety and tolerability and the analysis of drug regulated biomarkers.
Poster Presentation by 4SC:
Abstract: #30077
Poster Board: #II-691
Title: Resminostat In Relapsed or Refractory Hodgkin Lymphoma: Initial
Results of the SAPHIRE Phase II Trial with a Novel Oral Histone Deacetylase
(HDAC) Inhibitor
Session date and time: 5 December 2010, 6:00 PM - 8:00 PM, Poster session
on ' Lymphoma - Chemotherapy, excluding Pre-Clinical Models: Poster II'
Poster Presenter: Jan Walewski, MD, PhD, DSc, Ewa Paszkiewicz-Kozik, MD,
Gabriela Borsaru, MD, Andreea Moicean, MD, Agnieszka Warszewska, MD, Klaus
Strobel, MD, Alberto Biggi, MD, Bernhard Hauns, MD, Anna Mais, PhD, MSc,
Stefan W. Henning, PhD, MSc and Bernd Hentsch, PhD
- End -
About Resminostat (4SC-201)
Resminostat (4SC-201) is an oralpan-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 potential to halt
tumour progression and induce tumour regression. Resminostat is currently
in a Phase II study as a second line treatment for advanced hepatocellular
carcinoma and as a third-line treatment in Hodgkin's lymphoma. In a
completed Phase I trial in patients with various different cancer types,
stable disease was achieved in over 50% of the patients, whilst the
treatment was well tolerated and showed a positive, differentiating
pharmacological profile to other drugs in this class.
About Hodgkin's Lymphoma
Hodgkin's Lymphoma (HL) - formerly known as Hodgkin's Disease - is a cancer
of the lymphatic system, which is part of the immune system. The disease is
characterised by the prevalence of the Reed-Sternberg cell. In this disease
lymphatic cells grow abnormally and then spread beyond the lymphatic
system, which eventually compromises the immune system's ability to fight
infection. HL represents one main type of cancer of the lymphatic system.
Another type, the class of non-Hodgkin's lymphomas, is more common.
Symptoms of HL include the painless swellings of the lymph nodes, spleen or
other tissue, as well as fever, weight loss or night sweats.
Therapy options for HL depend on the stage of the disease and number and
regions of lymph nodes affected. The first line treatment of 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 comprises salvage chemotherapy
followed by high-dose chemotherapy and autologous stem cell
transplantation. Disease progression is monitored by computed tomography
(CT) in combination with magnetic resonance imaging (MRI) or positron
emission tomography (PET). In particular the recent incorporation of
functional imaging with PET scanning into disease evaluation has provided
significant additional information on the outcome of patients with relapsed
HL. For patients exhibiting a complete response after salvage chemotherapy,
5 year progression free survival (PFS) is 79%, but this number drops to 59%
for patients only exhibiting partial responses and drops further to 17% for
patients resistant to second line therapy regimens. Since there is no
standard of care in patients with resistant/refractory HL, there is an
especially high need to develop novel therapies for these patients.
About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development company
focused on autoimmune and cancer indications. Vidofludimus (4SC-101), a
small molecule, is currently in Phase II development in rheumatoid
arthritis and inflammatory bowel disease (IBD), for which positive results
from a Phase IIa study were recently reported. The company's lead oncology
compound, resminostat (4SC-201), a pan-histone deacetylase (HDAC)
inhibitor, is in Phase II trials in hepatocellular carcinoma and Hodgkin's
lymphoma. Two further oncology compounds, 4SC-203 and 4SC-205, are in Phase
I studies. 4SC develops drug candidates until proof-of-concept in order to
generate value creating partnerships with the pharmaceutical industry in
return for advance and milestone payments as well as royalties.
Founded in 1997, 4SC 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
Yvonne Alexander
Investor&Public Relations
Tel.: +49 (0) 89 70 07 63 - 66
yvonne.alexander(at)4sc.com
MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 - 30
raimund.gabriel(at)mc-services.eu
The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947
crubin(at)troutgroup.com
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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 München, Düsseldorf, Berlin, Stuttgart
End of Announcement DGAP News-Service
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Datum: 01.12.2010 - 07:30 Uhr
Sprache: Deutsch
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