Ad-hoc | 26 May 2010 08:44
4SC AG / Research Update
26.05.2010 08:44
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted by
DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Planegg-Martinsried, Germany, 26 May, 2010 - 4SC AG (Frankfurt, Prime
Standard: VSC), a drug discovery and development company focused on
autoimmune and cancer indications, today announced the decision to advance
the Phase II Hodgkin's lymphoma (HL) SAPHIRE study with the HDAC inhibitor
resminostat into the second Simon stage of patient recruitment. This
decision is based on the analysis of radiological imaging data from
patients treated in the first Simon stage through an independent central
assessment committee, which confirmed the achievement of the clinical
activity requirements for the advancement of the trial.
4SC announced that the first patient had been treated in this trial on
January 12, 2010. The Phase II SAPHIRE trial will continue into its second
stage of patient recruitment and final results are expected, as planned, in
the second half of 2011.
---------------------------------------------------------------------------
Information and Explaination of the Issuer to this News:
About the SAPHIRE Phase II study
The 33 patient, international, multi center, open-label, single-arm SAPHIRE
study follows a Simon two-stage trial design to allow for an initial
estimation on clinical drug activity at an early time point during the
trial. Therefore, the clinical activity data among the patients available
for efficacy analysis is evaluated in comparison to predefined activity
requirements at the point when approximately half of the anticipated number
of total patients is enrolled in the study. Only if this predefined extent
of clinical activity is observed in this first patient cohort, the study
will be extended by a second cohort of similar size in order to achieve the
overall statistical sample size requirements.
In this Phase II study resminostat is 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 trial, patients receive the
study treatment for six cycles (12 weeks). Disease assessments are
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 on study treatment for up to one year, after
which an optional continued treatment beyond this main study period is
offered for patients continuously benefiting from resminostat. The trial
will conclude when the last patient will have completed one year of
therapy, develops progressive disease or discontinues treatment for other
reasons. The study is enrolling 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.
Dr Bernd Hentsch, Chief Development Officer of 4SC, commented: 'It is very
exciting to see the SAPHIRE study with resminostat in patients with
advanced Hodgkin's lymphoma advancing so well. We now feel very encouraged
to progress this trial into its second Simon stage in order to assess
resminostat's therapeutic activity in an extended group of patients prior
to delivering comprehensive Phase II results.'
More information about the trial can be found on www.clinicaltrials.gov.
For further information please contact:
4SC AG
Yvonne Alexander
Investor Relations & Public Relations
Tel.: 49 (0) 89 70 07 63 66
yvonne.alexander@4sc.com
Notes to Editor
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 Resminostat (4SC-201)
Resminostat or 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
also currently in a Phase II study as a second line treatment for advanced
hepatocellular carcinoma (HCC), the most frequent form of liver cancer. In
addition, a further Phase I/II study is planned in colon cancer,
investigating resminostat as a second-line treatment in patients with KRAS
tumour mutations in combination with the FOLFIRI regimen. In Phase I 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 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.
26.05.2010 Ad hoc announcement, Financial News and Media Release distributed by DGAP.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
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@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
---------------------------------------------------------------------------