DGAP-News: Press Release: 4SC receives patent protection for its oncology compound resminostat in Taiwan and three other Asian growth markets
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Miscellaneous
Press Release: 4SC receives patent protection for its oncology
compound resminostat in Taiwan and three other Asian growth markets
01.03.2012 / 07:30
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Press Release
4SC receives patent protection for its oncology compound resminostat in
Taiwan and three other Asian growth markets
- Composition-of-matter patent granted in Taiwan; granting of patent
imminent in Korea, India and the Philippines
- Due to high occurrence of liver cancer (HCC) in the region,
Asia-Pacific is of strategic importance for the further development and
commercialisation of resminostat
Planegg-Martinsried, 1 March 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 in Asian-Pacific growth markets. With the key patent
for resminostat already granted in Taiwan (patent no. I353977), the patent
authorities in Korea, India and the Philippines recently indicated that the
granting of the composition-of-matter patent is now imminent in the
respective countries. The patents in these four countries cover the
composition of matter of the compound resminostat itself, pharmaceutical
compositions comprising resminostat, and its therapeutic use in cancer and
other therapeutic areas.
The Asia-Pacific markets are of a high importance for the development and
commercialisation of resminostat. Occurrences of liver cancer
(hepatocellular carcinoma, HCC) are especially high in these countries, for
instance accounting for 14% of all new cases of cancer in Taiwan - as well
as China - and for 9% in Korea and the Philippines. Liver cancer, a disease
with a high medical need for which only very few treatment options are
available, is one of the cancer indications currently addressed with
resminostat in clinical Phase II trials. Resminostat has already shown
promising anti-tumour activity in this indication. In April 2011, 4SC
entered into a first development and commercialisation partnership in this
growth region 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 that the Taiwanese patent authority has granted this key
patent for our lead oncology compound resminostat and that patent granting
is imminent in Korea, India and the Philippines. This bolsters our market
position in the Asia-Pacific region, which is very important commercially -
especially for the development of resminostat in the indication of liver
cancer (HCC). After we recently reached our primary efficacy endpoint ahead
of schedule in a Phase II trial in patients with advanced HCC, we are now
in talks with regulatory agencies and potential partners to prepare a
global registration trial of resminostat in this indication. We believe
that the enhanced patent protection in these Asian growth markets 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 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 combination with other cancer drugs. 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. Additionally,
resminostat also induces what is known as tumour cell 're-sensitisation'.
This process can suppress or reverse tolerance and resistance mechanisms
that tumour cells often develop against other cancer drugs. Accordingly,
supplementary treatment with resminostat can 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), which is a cancer of the lymphatic system,
and colorectal cancer (CRC). 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 SAPHIRE trial in patients with advanced
Hodgkin's Lymphoma, resminostat monotherapy has demonstrated, with an
overall response rate of 35.3% and a clinical benefit in 55.9% of the
patients, substantial anti-tumour activity in a heavily pre-treated patient
population together with very good safety and tolerability. In the active
Phase II SHELTER study resminostat is being evaluated as monotherapy and in
combination with sorafenib (Nexavar(R)) as a second-line treatment in
advanced HCC. According to the data presented in January 2012, based on an
advanced data set, 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 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 after 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. 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 4SC AG
4SC (ISIN DE0005753818) discovers and develops targeted small-molecule
drugs for the treatment of diseases with a high unmet medical need in
various autoimmune and cancer indications. These drugs are intended to
provide patients with 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 currently has 94
employees and 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 anumber of factors.
For more information please visit www.4sc.com or contact:
4SC AG
Jochen Orlowski, Investor Relations&Public Relations
jochen.orlowski(at)4sc.com, Tel.: +49 (0) 89 70 07 63 66
Bettina v. Klitzing-Stückle, Corporate Communications
bettina.von.klitzing(at)4sc.com, Tel.: +49 (0) 89 70 07 63 0
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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01.03.2012 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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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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