DGAP-News: Press Release 4SC AG: 4SC's partner Yakult Honsha starts clinical development with cancer compound resminostat in Japan
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Press Release 4SC AG: 4SC's partner Yakult Honsha starts clinical
development with cancer compound resminostat in Japan
15.05.2012 / 07:30
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Press Release
4SC's partner Yakult Honsha starts clinical development with cancer
compound resminostat in Japan
- The Phase I study will assess safety of resminostat in Japanese patients,
which is a prerequisite of the drug's further late-stage clinical
development in Japan
- 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, 15 May 2012 - 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 in a Japan-based Phase I clinical study with
4SC's cancer drug resminostat. The open-arm, dose-escalating study is being
conducted by Yakult Honsha, 4SC's Japanese co-development and marketing
partner. The study will evaluate safety and tolerability of resminostat in
Japanese patients with advanced solid tumours. It will furthermore
investigate the drug's efficacy, pharmacokinetics and pharmacodynamics.
The development of resminostat in the Japanese market is of high strategic
importance to 4SC for two reasons. In April 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. Hepatocellular carcinoma (HCC), the most common type
of liver cancer with a high medical need and only few available therapeutic
options has a particularly high incidence in Japan. HCC is one of the
cancer indications targeted with resminostat in advanced clinical
development.
Dr. Ulrich Dauer, Chief Executive Officer of 4SC AG, said: 'We are very
pleased that our Japanese partner Yakult Honsha has started the clinical
development of resminostat in Japan. This is of high relevance for both our
alliance with Yakult in Japan and the further development strategy for
resminostat in this important market. The primary goal of the study is to
prove that the drug is safe and well tolerated in Japanese patients, which
is a key prerequisite for resminostat's further development in this region.
We are currently in discussions with regulatory authorities and potential
partners to prepare for a global pivotal clinical study programme with
resminostat in patients with advanced liver cancer (HCC). Given the high
incidence of HCC in Japan and the whole of Asia, gaining market approval in
this region is a key goal for us.'
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 is expected to enable 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'. This process can suppress or
reverse certain tolerance and resistance mechanisms which tumour cells
often develop against other cancer drugs. Accordingly, supplementary
treatment with resminostat may thus restore - or significantly improve -
the efficacy of an initial cancer therapy.
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. 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 disease progression under
first-line sorafenib therapy. According to the data presented at the
ASCO-GI annual meeting in January 2012, the primary study endpoint has been
achieved ahead of schedule in both therapy arms showing a progression-free
survival rate (PFSR) after 12 weeks of 66.6% for the combination therapy
group and of 33.3% for 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. HCC is the most frequent form of liver cancer,
the fifth most common cancer worldwide and, with approximately 700,000
deaths annually, the third most deadly. The kinase inhibitor sorafenib is
currently the only drug approved in first-line therapy of advanced HCC. No
approved treatment option is available for patients who become refractory
or intolerant to sorafenib treatment (second-line therapy).
About the Resminostat Partnering Deal 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 product sales 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 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 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 (0) 89 70 07 63 66
MC Services
Raimund Gabriel
raimund.gabriel(at)mc-services.eu , Tel.: +49 (0) 89 21 02 28 30
Mareike Mohr
mareike.mohr(at)mc-services.eu, Tel.: +49 (0) 89 21 02 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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