DGAP-News: 4SC Announces Initial Phase II Data from the SAPHIRE Study with Resminostat at the 8th International Symposium on Hodgkin Lymphoma
(firmenpresse) - 4SC AG / Key word(s): Research Update
26.10.2010 07:30
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Planegg-Martinsried, Germany, 26. October 2010 - 4SC AG (Frankfurt, Prime
Standard: VSC), a drug discovery and development company focused on
autoimmune and cancer indications, announces the presentation of Phase II
data from Hodgkin Lymphoma patients treated in the 1st Simon Stage cohort
of the ongoing SAPHIRE study with resminostat (4SC-201), an oral
pan-histone deacetylase (HDAC) inhibitor, at the 8th International
Symposium on Hodgkin Lymphoma in Cologne, Germany.
The oral presentation will be given by the lead investigator of the SAPHIRE
study, Prof Dr Jan Walewski of the Marie-Sk?odowska-Curie Memorial
Institute in Warsaw, Poland. It highlights initial safety and tolerability
as well as efficacy data from the first 18 patients with relapsed or
refractory Hodgkin Lymphoma in this study.
Daily oral application of 600 mg resminostat for 5 consecutive days per
2-week treatment cycle was well tolerated with the majority being mild to
moderate gastrointestinal and haematological side effects. In addition, a
number of anaemia cases were observed, however these were judged as being
primarily related to the underlying disease. Pharmacokinetic data indicate
good bioavailability of this HDAC inhibitor and plasma exposure levels
yielded significant pharmacodynamic activity as exemplified by time
dependent HDAC enzyme inhibition after dosing.
In this first patient cohort, the average treatment duration with
resminostat reached approximately nine weeks. Anti-tumour activity of the
drug was assessed every six weeks by combination of computer tomography
(CT) and positron-emission tomography (PET), a technique which allows the
simultaneous evaluation of changes in the metabolic activity and the size
of a tumour lesion. Based on established PET/CT evaluation criteria, 10
patients out of 18 benefited from treatment with resminostat with two
patients being assessed as partial responders (PR) (i.e. more than 50%
reduction in size of tumour lesions) and a further eight patients with
stabilization of disease (SD). Based on PET analysis almost all of these
patients showed a diminished metabolic activity of their lesions with the
majority being evaluated as partial metabolic responders (more than 25%
decrease in PET activity). These results are based on intermediate analysis
of the data and are therefore subject to final review.
According to the statistical design of the SAPHIRE study (Simon two-stage
design), a minimum number of five responders were required in this reported
1st Simon stage in order to extend the study to a second enrolment phase of
an additional 15 patients (the 2nd Simon stage). After reaching this
threshold the study has recently proceeded into the 2nd Simon stage
recruitment phase. Due to the good tolerability and side effect profile
observed in this relatively young HL patient population an optional
increase of the daily dose of resminostat from 600 mg to 800 mg has been
implemented.
Prof Walewski of the Marie-Sk?odowska-Curie Memorial Institute in Warsaw,
Poland, the lead investigator of the SAPHIRE study, commented: 'Despite the
fact that patients with Hodgkin Lymphoma often respond well to first-line
treatment with chemotherapy, there is an urgent medical need for new
therapeutic approaches for patients relapsing or becoming refractory to
standard therapy. For patients not responding to second line high-dose
chemotherapy the 5-year progression-free survival rate is as low as 17%.
Hodgkin Lymphoma patients are often very young and the repeated use of
chemotherapy can lead to secondary tumour developments in addition to the
primary lymphatic cancer. Based on the initial data presented on the 1st
Simon stage of the trial, we are hopeful that resminostat may provide a new
therapy option to relapsed or refractory HL patients.'
Dr Bernd Hentsch, Chief Development Officer at 4SC, commented: 'We were
very pleased with these initial results and are hopeful of the potential of
our oral, pan-HDAC Inhibitor resminostat as a monotherapy treatment for
advanced Hodgkin Lymphoma patients. We feel that this indication could
provide a clinical proof-of-concept for resminostat, which is currently
also being evaluated as a combination treatment in solid tumour
indications.'
For more information please contact
4SC AG
Bernd Hentsch, Chief Development Officer
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
Notes to the editor
About Resminostat (4SC-201)
Resminostat or 4SC-201 is an oral pan-histone-deacetylase (HDAC) inhibitor.
HDAC inhibitors epigenetically modify the chromatin 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 in a Phase II study as a second line
treatment for advanced hepatocellular carcinoma (HCC) and in a Phase II
study in Hodgkin's lymphoma. In addition, a further Phase I/II study is
planned in colon cancer, investigating resminostat as a second-line
treatment option in patients with KRAS tumour mutations in combination with
the FOLFIRI regimen. In a previous Phase I study with resminostat in
patients with various 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 SAPHIRE
The SAPHIRE study is an open-label, single-arm, Simon two-stage design
Phase II study where resminostat will be given orally daily for five
consecutive days, followed by a nine day treatment free period ('5+9'
dosing schedule). In the main phase of the study, patients will receive
treatment for six cycles (12 weeks). Disease assessments will be performed
after treatment cycles three and six by computed tomography in combination
with positron emission tomography (PET/CT), as recommended by the
International Working Group (IWG) criteria for the evaluation of HL.
Patients showing response or stable disease at the end of the main
treatment phase may continue to the follow-up phase and can remain on
medication for up to one year. The trial will conclude when the last
patient remaining will have completed one year of therapy, develops
progressive disease or discontinues treatment for other reasons. The study
is expected to enrol 33 patients across 10 sites in Poland, Romania and the
Czech Republic.
The primary endpoint of the study is to determine the ORR (objective
overall response rate) of resminostat in patients who are refractory to
first line treatment or have relapsed after responding to first line
therapy. The secondary endpoints include assessment of PFS (progression
free survival), TTP (time to progression), DOR (duration of response) and
OS (overall survival), as well as the analysis of safety and tolerability
of the treatment.
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, however, far 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 a Phase IIb study in rheumatoid arthritis
and a Phase IIa exploratory study in inflammatory bowel disease. 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.
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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: 26.10.2010 - 07:30 Uhr
Sprache: Deutsch
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