DGAP-News: Press Release: 4SC's partner Yakult Honsha starts clinical Phase I/II study with cancer compound resminostat in liver cancer in Japan
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Miscellaneous
Press Release: 4SC's partner Yakult Honsha starts clinical Phase I/II
study with cancer compound resminostat in liver cancer in Japan (with
additional features)
21.05.2013 / 07:30
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Press Release
4SC's partner Yakult Honsha starts clinical Phase I/II study with cancer
compound resminostat in liver cancer (HCC) in Japan
- Phase I/II study to investigate safety and efficacy of
resminostat/sorafenib combination vs. sorafenib alone as first-line
treatment of advanced liver cancer (HCC)
- Clinical development of resminostat in Japan is of high strategic
importance to 4SC because of its alliance with Yakult and the high
incidence of liver cancer in this region
Planegg-Martinsried, Germany, 21 May 2013 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune diseases and cancer, today announced that the
first patient has been treated with resminostat in a Japan-based Phase I/II
liver cancer (hepatocellular carcinoma, HCC) clinical study by its
exclusive Japanese partner Yakult Honsha. The multi-centre study will
investigate safety and efficacy of resminostat in combination with the
cancer drug sorafenib as a potential novel first-line treatment of advanced
liver cancer in up to 164 patients. All patients enrolled have to be
previously untreated with systemic chemotherapy.
The dose-escalation Phase I part of the study will assess safety,
tolerability and pharmacokinetics as well as determine the maximum
tolerated dose (MTD) and potential dose-limiting toxicities (DLT) of the
resminostat/sorafenib combination in order to establish a recommended dose
(RD) for the Phase II part.
The randomised Phase II part will compare the efficacy of sorafenib alone
with the combination therapy of resminostat and sorafenib as a first-line
treatment of patients with advanced HCC. A total daily dose of 800 mg
sorafenib will be administered as monotherapy in the control arm of the
study or in combination with up to 600 mg/day resminostat in the second
study arm. The primary endpoint of the Phase II part is to measure
time-to-progression (TTP), secondary endpoints of the Phase II part are,
inter alia, overall survival (OS), progression-free survival (PFS) and
safety.
The development of resminostat in the Japanese market is of high strategic
importance to 4SC and its partner Yakult Honsha. In 2011, 4SC granted an
exclusive license to Yakult Honsha, the Japanese market leader in
gastro-intestinal cancer therapeutics, for the development and
commercialization of resminostat in Japan. Liver cancer (HCC), a disease
with a particularly high incidence in Japan as well as in the whole of
Asia, is one of the main indications of clinical development with
resminostat. There is a high medical need for new treatment options for
advanced HCC, with sorafenib being the only approved systemic treatment
available.
Enno Spillner, Chief Executive Officer and Chief Financial Officer of 4SC
AG, said: 'We are very pleased that our Japanese partner Yakult Honsha has
started clinical development of resminostat in advanced liver cancer (HCC)
in Japan. Given the high incidence of HCC in Japan and the whole of Asia,
advancing the drug towards market approval in this region isa key
strategic goal for us. Moreover, this is the first time resminostat is
being investigated in the first-line treatment of advanced HCC. This is of
high relevance to 4SC, as we are currently in preparations of the next
advanced clinical development steps for resminostat in combination with
sorafenib in first-line HCC in the Western population as well.'
Ends
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 particular, 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 (re-)sensitisation to other anti-cancer
compounds. This process can suppress or reverse certain tolerance and
resistance mechanisms which tumour cells often develop against other 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, positive
interim results for safety and tolerability have been published in December
2012. Final Phase I results are expected to be published soon. Furthermore,
in the Phase II SHELTER study resminostat has been evaluated as monotherapy
and in combination with sorafenib as a second-line treatment in advanced
HCC after proven radiological disease progression under first-line
sorafenib therapy. Patients receiving the resminostat/sorafenib combination
therapy showed a median overall survival of 8.0 months (as reported at the
annual meeting of the International Liver Cancer Association (ILCA) on 16
September 2012). As presented at the ASCO annual meeting on 4 June 2012,
the resminostat/sorafenib combination therapy had shown a progression-free
survival rate (PFSR) after 12 weeks of 70.0% and a median PFS of 4.7
months. The primary study endpoint was 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 the next clinical steps to develop resminostat
in combination with sorafenib towards market approval as a first-line
treatment for patients with advanced HCC.
About the Resminostat Partnering Agreement with Yakult Honsha for Japan
4SC granted an exclusive license to Yakult Honsha for the development and
commercialization of resminostat in Japan in April 2011. 4SC has received
an upfront payment from Yakult Honsha of EUR6 million and is eligible for
up to EUR127 million payable upon achieving specified milestones including
clinical and regulatory events in Japan. In addition to milestone payments,
Yakult will pay 4SC double-digit royalties linked to productsales of
resminostat. Yakult Honsha will be responsible for all clinical
requirements for resminostat development in Japan in HCC, CRC and other
chosen oncology indications. 4SC is aiming to partner this compound in
other territories, including Europe, the USA and Asia.
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 86 employees at
the end of 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 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 visit www.4sc.com or contact:
4SC AG
Jochen Orlowski, Corporate Communications&Investor Relations
jochen.orlowski(at)4sc.com, Tel.: +49-89-700763-66
MC Services
Raimund Gabriel, Mareike Mohr
raimund.gabriel(at)mc-services.eu , Tel.: +49-89-2102-28-30
mareike.mohr(at)mc-services.eu, Tel.: +49-89-2102-28-40
The Trout Group (USA)
Chad Rubin
Crubin(at)troutgroup.com, Tel.: +1-646-378-2947
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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