DGAP-News: 4SC Presents Initial Data from the Resminostat (4SC-201) Phase II SHELTER study in Hepatocellular Carcinoma (HCC)
(firmenpresse) - 4SC AG / Key word(s): Miscellaneous
17.09.2010 07:30
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Lead Investigator Professor Dr. Michael Bitzer to present data at
gastroenterology and visceral surgery symposium 'Viszeralmedizin 2010' -
Planegg-Martinsried, Germany, 17 September 2010 - 4SC AG (Frankfurt, Prime
Standard: VSC), a drug discovery and development company focused on
autoimmune and cancer indications, will today present initial clinical data
for resminostat (4SC-201), a pan-histone deacetylase (HDAC) inhibitor, from
the ongoing, two-arm, Phase II SHELTER study in hepatocellular carcinoma
(HCC). The data will be presented by the lead investigator, Prof. Dr.
Michael Bitzer, at the 'Viszeralmedizin 2010' Symposium, organized by the
German Gastroenterology (DGVS) and Visceral Surgery Associations (DGAV) in
Stuttgart, Germany. The SHELTER trial is evaluating the efficacy, safety
and tolerability of resminostat as a monotherapy or in combination with the
current first line therapy standard, sorafenib, in sorafenib-refractory HCC
patients.
The poster presentation highlights safety and tolerability data from the
first nine patients from this clinical study, which aims to recruit about
60 HCC patients including the dose escalation of the combination of
resminostat and sorafenib. Resminostat was safe and well tolerated in the
combination arm of the study with doses of up to 400 mg of sorafenib
applied continuously every day and 400 mg of resminostat using its Phase I
tested '5 + 9' dosing schedule, resulting in 14 day treatment cycles, as
well as in the second study arm in which resminostat is applied as
monotherapy at a daily dose of 600 mg using again the '5 + 9' dosing
schedule. Furthermore, no pharmacokinetic interactions were observed
between resminostat and sorafenib. At the time of study entry, patients had
documented progressive disease under sorafenib therapy. Following
initiation of the trial therapy, a considerable portion of patients showed
stabilisation of their disease (Stable Disease according to RECIST
criteria) after 6 or 12 weeks of study treatment. Six out of nine patients
examined for their tumour disease status after 6 weeks showed Stable
Disease, and three out of four patients examined after 12 weeks of therapy
displayed continued disease stabilisation. Patients may remain on therapy
as long as a clinical benefit is recorded. In certain cases, patients
remained stable for more than 12 weeks of study treatment. One patient in
the combination arm, receiving 400 mg of resminostat and 400 mg of
sorafenib has been treated for 36 weeks with documented Stable Disease.
Prof. Dr. Michael Bitzer, the lead investigator from the University
Hospital Tübingen, Germany, commented: 'Advanced HCC is an aggressive form
of cancer for which there is an especially high medical need for new
treatments as there are currently no approved second line therapies for HCC
patients. The SHELTER trial provides the evaluation for a new mechanism of
action in this indication, which may hold promise for these patients who
have no treatment options left.'
Dr. Bernd Hentsch, Chief Development Officer at 4SC, commented: 'This is
the first of three indications where we evaluate the potential of the
pan-HDAC Inhibitor resminostat in cancer. The initial clinical data of the
SHELTER study is very encouragingas it supports our earlier Phase I
results and leads us to believe this drug could be a viable option for HCC
patients.'
More information about the trial can be found on www.clinicaltrials.gov.
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 the SHELTER study
The 'Shelter' study, 'A proof-of-concept Phase II study to evaluate
efficacy, safety and pharmacokinetics of 4SC-201 and of the treatment
combination of Sorafenib plus 4SC-201 in patients with hepatocellular
carcinoma exhibiting progressive disease under sorafenib treatment', is
examining whether treatment with resminostat (4SC-201) alone or in
combination with sorafenib (Nexavar(R), the current standard of care in
advanced HCC), can improve progression free survival or induces tumour
responses in HCC patients. This two-arm, proof-of-concept study is
performed at oncology-experienced University hospitals in Germany.
In the first study arm, 15 patients are being treated with the maximum
tolerated dose of the combination therapy which was determined through an
initial dose-escalation part of the study, testing sorafenib in combination
with resminostat. In the second study arm 15 patients discontinue sorafenib
treatment prior to inclusion and then receive 600 mg of resminostat as a
mono-therapy. Resminostat is orally administered, once daily, over five
consecutive days, followed by a nine day treatment free period. In the
combination arm sorafenib is administered every day. In both study arms,
the resulting 14 day cycle for the treatment with resminostat (a '5 + 9'
dosing schedule) is repeated until there is evidence of progressive disease
or until the patient leaves the study for other reasons. The first two
radiological tumour stagings will be performed after six and 12 weeks.
Patients who experience a clinical benefit, e.g., a stabilization of their
progressive disease or tumour regression, may extend the study treatment.
Based on the data of the first 15 patients treated in each study arm, an
optional extension phase comprising ten additional patients may be included
into each study arm. The primary endpoint of the study is to determine the
progression free survival rate (PFSR) after twelve weeks of study
treatment. The secondary endpoints include the analysis of
time-to-progression (TTP), PFSR estimated at six weeks of treatment,
overall survival, analysis of drug safety, tolerability, pharmacokinetics
and the investigation of biomarkers.
About Hepatocelluar Carcinoma (HCC)
Hepatocellular carcinoma is the most prevalent form of liver cancer. HCC is
the sixth most common cancer in the world and the third leading cause of
cancer-related deaths globally.
HCC is most prevalent in Southeast Asia and is also very common in
sub-Saharan Africa (an estimated 20 cases per 100,000 population by the
World Health Organisation (WHO)). This is because in these geographies
there is a high rate of Hepatitis B virus (HBV) infection, which may cause
liver cancer as its genetic material disrupts the normal genetic material
in the liver cells, thereby causing the liver cells to become cancerous.
Historically, North America and Western Europe, has had less incidence
(
tripled between 1975 and 2005 and researchers believe that these trends may
be partially due to an increase in chronic hepatitis C infections, which
along with hepatitis B is a major risk factor for liver cancer. Other
factors that may contribute to the increase in liver cancer include: heavy
alcohol consumption, fatty liver disease, obesity, diabetes mellitus and
iron storage diseases.
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: 17.09.2010 - 07:30 Uhr
Sprache: Deutsch
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