DGAP-News: Press Release: 4SC obtains key patent for anti-cancer compound resminostat in China
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Miscellaneous
Press Release: 4SC obtains key patent for anti-cancer compound
resminostat in China
01.10.2012 / 07:30
---------------------------------------------------------------------
Press Release
4SC obtains key patent for anti-cancer compound resminostat in China
- Due to large market size and high occurrence of liver cancer, China is
of key strategic importance for the further development and
commercialisation of resminostat
Planegg-Martinsried, 1 October 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 company has
significantly enhanced the patent protection for its lead anti-cancer
compound resminostat. 4SC has received a notification of allowance for
patent protection of resminostat in China, the third largest pharmaceutical
market worldwide, from the Chinese patent authority (SIPO). Thus the
granting of the composition-of-matter patent is now imminent. The patent,
having a very broad extent of protection, covers the composition of matter
of resminostat, pharmaceutical compositions comprising resminostat, and its
therapeutic use in cancer and other areas.
China is by far the country with the highest incidence rates of liver
cancer in the world and, therefore, of key importance for the further
development and commercialisation of resminostat. Liver cancer
(hepatocellular carcinoma, HCC), a disease with a high medical need and
only very few treatment options available, is one of the indications
currently addressed with resminostat in clinical Phase II trials.
Resminostat has recently shown excellent Phase II results in this
indication, achieving a median overall survival (OS) of 8.0 months in
second-line HCC patients in the combination treatment with sorafenib
(Nexavar(R)).
According to the World Health Organization (GLOBOCAN 2008), there were more
than 400,000 incidences of liver cancer in China in 2008 - accounting for
14% of all new cases of cancer in this country. The number of new cases of
liver cancer per year in China is expected to grow to 550,000 by the year
2020. According to IMS Health, China - with a total volume of 50 bn. USD -
is the world's third largest pharmaceutical market behind the USA and
Japan. Until 2020, analysts estimate a further growth of this sector in
China by 18 to 25% per year. Due to the high occurrence of hepatitis
infections, liver cancer has particularly high incidence rates in the whole
Asian-Pacific region. 4SC entered into a first development and
commercialisation partnership in this growth region in April 2011, when it
granted an exclusive license for resminostat to Yakult Honsha, the Japanese
market leader for gastrointestinal cancer therapies.
Dr. Ulrich Dauer, Chief Executive Officer of 4SC AG, commented: 'We are
very pleased to obtain this key patent for our lead anti-cancer compound
resminostat in China. This bolsters our competitive position in this large
and attractive market as well as in the whole Asian-Pacific region, which
is commercially very important for the development of resminostat in the
indication of liver cancer (HCC). After we have recently shown excellent
overall survival data in a Phase II trial in patients with advanced HCC, we
are currently in talks with regulatory agencies and potential partners to
prepare a global registration trial with resminostat in this indication. We
believe that the enhanced patent protection in China will serve to further
advance the successful progress of these talks with potential partners.'
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, 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 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 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
30 June 2012. 4SC AG has been listedon 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
Mareike Mohr, Raimund Gabriel
mareike.mohr(at)mc-services.eu, Tel.: +49 (0) 89 21 02 28 30
The Trout Group
Chad Rubin
Crubin(at)troutgroup.com, Tel.: +1 646 378 2947
End of Corporate News
---------------------------------------------------------------------
01.10.2012 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
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
---------------------------------------------------------------------
186983 01.10.2012
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Bereitgestellt von Benutzer: EquityStory
" alt="Riverstone Appoints New Chief Operating OfficerDatum: 01.10.2012 - 07:30 Uhr
Sprache: Deutsch
News-ID 187990
Anzahl Zeichen: 12198
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 213 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: Press Release: 4SC obtains key patent for anti-cancer compound resminostat in China"
steht unter der journalistisch-redaktionellen Verantwortung von
4SC AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
