DGAP-News: Press Release: 4SC to present biomarker data for cancer drug Resminostat from Phase II trial in Hodgkin's lymphoma
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Press Release: 4SC to present biomarker data for cancer drug
Resminostat from Phase II trial in Hodgkin's lymphoma
15.06.2012 / 07:33
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Press Release
4SC to present biomarker data for cancer drug Resminostat from Phase II
SAPHIRE trial in Hodgkin's lymphoma at EHA Meeting in Amsterdam
Planegg-Martinsried, Germany - 15 June 2012 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune diseases and cancer, will today present data
of a set of biomarkers and their possible utility for stratification of
patient populations analysed in the clinical Phase II SAPHIRE study with
its anti-cancer compound resminostat in patients with relapsed/refractory
Hodgkin's lymphoma (HL) at the 17th Congress of the European Hematology
Association (EHA) in Amsterdam, The Netherlands from 14-17 June 2012.
The poster will be presented at the Hogdin's lymphoma session today,
Friday, 15 June 2012, from 5:45-7:00 pm (CEDT) and will report new data on
the correlation of resminostat plasma levels and its pharmacodynamic effect
on a set of biomarkers, including HDAC enzyme inhibition and the level of
critical plasma proteins such as TARC. Furthermore, based on expression
analysis of a set of marker genes regulated by resminostat, the
identification and potential of certain gene expressions to serve as either
additional pharmacodynamic markers or to qualify as biomarkers for patient
stratification or prediction of clinical response to resminostat will be
discussed.
Dr. Bernd Hentsch, Chief Development Officer, commented: 'Our biomarker
analysis program has resulted in the identification of novel gene
expressions that may serve as tools for the identification of those HL
patients who could have a higher chance of obtaining a clinical benefit
from resminostat treatment. This approach now opens the opportunity to
target resminostat therapy more effectively to this patient group.
Furthermore, we are applying this biomarker program to all our target
indications, including HCC and CRC, in order to also explore possible
stratification opportunities for those patients.'
The final efficacy data of the SAPHIRE study evaluating resminostat
monotherapy in relapsed and/or refractory Hodgin's lymphoma patients had
been presented at last year's ASH conference. The study met the primary
efficacy endpoint with an overall response rate (ORR) of 35.3% and a
clinical benefit in 55.9% of these heavily pretreated patients together
with a very clean safety and tolerability profile. The open-label,
single-arm, international study evaluated safety, pharmacokinetics,
biomarkers, and efficacy of resminostat monotherapy treatment in 34
patients with advanced HL. Patients enrolled in the trial had either
relapsed after high dose chemotherapy and/or autologous stem cell
transplantation (ASCT) or had become refractory to treatment, and had on
average received 6 prior treatments.
From today, 15 June 2012, 5:45 pm (CEDT), the detailed findings presented
at the EHA meeting can also be downloaded at
http://www.4sc.de/product-pipeline/publications-posters/resminostat.
Ends
Details of the Presentation:
Presentation Title: 'Efficient HDAC inhibition and TARC reduction in
patients with refractory Hodgkin's lymphoma treated with Resminostat. PK/PD
data from the Phase II SAPHIRE study'
Session date and time: Friday, 15 June 2012, 5:45 PM (CEDT)
Session name: Hodgkin's lymphoma
Authors/Presenters: J. Walewski1, G. Borsaru2, A. Moicean3, A.Hellmann4, A.
Janikova5, B. Hauns6, A. Mais6, A. Ammendola6, T. Herz6, H. Kohlhof6, S.W.
Henning6, B. Hentsch6
1 Department of Lymphoid Malignancies, Maria Sk?odowska-Curie Memorial
Institute and Oncology Centre, Warszawa, Poland;
2 Clinical Hospital Coltea, Bucharest, Romania;
3 Center of Hematology&Bone Marrow Transplantation, Bucharest, Romania;
4 Department for Hematology&Transplantology, University Clinical Centre,
Medical University of Gdansk, Gdansk, Poland;
5 Department of Internal Medicine, Hematology&Oncology, University
Hospital Brno, Brno, Czech Republic;
6 4SC AG, Martinsried, Germany
About the SAPHIRE Trial Design
The SAPHIRE trial included HL patients that had relapsed after high dose
chemotherapy and/or autologous stem cell transplantation (ASCT) or had
become refractory to treatment. The study was designed as an open-label,
single-arm, international trial consisting of two recruitment stages
according to the Simon's Minimax design. Resminostat has been administered
orally at a once daily dose of 600 mg during the 1st recruitment stage and
due to its good tolerability at a higher daily dose of 800 mg in the 2nd
stage. Patients were treated in 14-day cycles of five consecutive days
followed by a nine-day treatment-free period (5+9 schedule). Patients
underwent assessment of their disease status by computed tomography in
combination with positron emission tomography (PET/CT) after Cycle 3 and
Cycle 6 and thereafter every fourth cycle during an optional follow-up
period in which patients could continue treatment until disease
progression. The primary endpoint of the study was defined as the overall
objective response rate (ORR) based on the best objective response during
treatment. Secondary endpoints included time to response (TTR), duration of
response (DOR), progression free survival (PFS), overall survival (OS),
safety and tolerability and the evaluation of drug regulated biomarkers
including the assessment of TARC levels as well as gene and protein
expression profiling.
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 however also 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 originates 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 and 30 years and the second in the seventh
decade.
HL is effectively treatable in the majority of cases. However, not all
patients respond to current standard therapy strategies and available
treatments 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), 4SC's lead oncology compound, is an oral
pan-histone-deacetylase (HDAC) inhibitor with an innovative epigenetic
mechanism of action that potentially enables the compound to be deployed as
a novel, targeted tumour therapy for a broad spectrum of oncological
indications, both as a monotherapy and in combination with other cancer
drugs. HDAC inhibitors have been shown to 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. Additionally, resminostat is also assumed to induce what
is known as tumour cell 'sensitisation' to other anti-cancer compounds.
This process can suppress or reverse certain tolerance mechanisms which
tumour cells often develop against such cancer drugs. Supplementary
treatment with resminostat can be expected to restore or significantly
improve the efficacy of a previously administered cancer therapy which was
no longer effective; furthermore, combining resminostat and common cancer
drugs right from the very beginning can also be expected to effectively
enhance the success of such a treatment.
Resminostat is currently being investigated in a broad clinical Phase II
programme in the three indications liver cancer (hepatocellular carcinoma,
HCC), Hodgkin's Lymphoma (HL), and colorectal cancer (CRC). In the Phase II
SAPHIRE trial in patients with advanced Hodgkin's Lymphoma, resminostat in
monotherapy has demonstrated substantial anti-tumour activity, with an
overall response rate of 35.3% and a clinical benefit in 55.9% of the
patients in a heavily pre-treated patient population together with very
good safety and tolerability. In the Phase I/II SHORE study, which
evaluates resminostat in combination with the chemotherapeutic FOLFIRI
regimen as a second-line treatment of KRAS-mutant CRC patients, initial
results are expected in 2012. Furthermore, in the Phase II SHELTER study
resminostat is being evaluated as monotherapy and in combination with
sorafenib as a second-line treatment in advanced HCC after radiologically
proven disease progression under first-line sorafenib therapy. According to
the data presented at the ASCO annual meeting on 4 June 2012, resminostat /
sorafenib combination therapy showed a progression-free survival rate
(PFSR) after 12 weeks of 70.0% and a median PFS of 4.7 months. The primary
study endpoint has been achieved ahead of schedule in both the combination
and the monotherapy group.
4SC is currently in discussions with regulatory agencies and potential
partners in order to prepare a pivotal clinical study programme for
resminostat in combination with sorafenib as a second-line treatment for
patients with advanced HCC who show tumour progression on first-line
treatment with sorafenib.
About 4SC
The Group managed by 4SC AG (ISIN DE0005753818) discovers and develops
targeted, small-molecule drugs for treating diseases with high unmet
medical needs in various autoimmune and cancer indications. These drugs are
intended to provide 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 had 90 employees at
31 March 2012. 4SC AG 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 orrelating 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 visit www.4sc.com or contact:
4SC AG
Jochen Orlowski, Corporate Communications&Investor Relations
jochen.orlowski(at)4sc.com, Tel.: +49 (0) 89 70 07 63 66
MC Services
Raimund Gabriel
raimund.gabriel(at)mc-services.eu, Tel.: +49 (0) 89 21 02 28 30
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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