DGAP-News: Press Release: 4SC's partner Yakult Honsha starts clinical Phase I/II study with cancer compound resminostat in non-small-cell lung cancer (NSCLC) 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 non-small-cell lung cancer
(NSCLC) in Japan
25.07.2013 / 07:30
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Press Release
4SC's partner Yakult Honsha starts clinical Phase I/II study with cancer
compound resminostat in non-small-cell lung cancer (NSCLC) in Japan
- The Phase I/II study will investigate safety and efficacy of
resminostat/docetaxel combination vs. docetaxel alone as a novel treatment
option for patients with advanced, metastatic, or recurrent NSCLC
- NSCLC is thus the third solid cancer indication in which 4SC's epigenetic
compound resminostat has started clinical development (besides HCC and
CRC).
Planegg-Martinsried, Germany, 25 July 2013 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for cancer and autoimmune diseases, today announced that the
first patient has been treated with resminostat in a Japan-based Phase I/II
lung cancer (non-small-cell lung cancer, NSCLC) clinical study conducted by
its exclusive Japanese partner Yakult Honsha. The multi-centre and
randomised study will investigate safety and efficacy of resminostat in
combination with the cancer drug docetaxel vs. docetaxel alone in up to 118
patients in total with advanced, metastatic, or recurrent NSCLC who have
previously received one platinum-based 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/docetaxel combination in order to determine a recommended dose
(RD) for the Phase II part.
The randomised Phase II part will compare the efficacy of docetaxel alone -
a standard chemotherapeutic regimen for NSCLC - with the combination
therapy of resminostat and docetaxel in the enrolled NSCLC patients. In a
21 day cycle docetaxel (75 mg/m2 body surface area, administered
intravenously on Day 1) will be given either as monotherapy in the control
arm or in combination with resminostat (up to 600 mg/day, orally
administered on Days 1-5) in the second study arm. Depending on the nature
of potential side-effects observed, the dose of docetaxel may be reduced.
The primary endpoint of the Phase II part is progression-free survival
(PFS), secondary endpoints include response rate (RR), overall survival
(OS), and safety.
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. In 2012 Yakult Honsha
started the clinical development of resminostat in Japan with a Phase I
study in solid tumours followed in 2013 by a Phase I/II study in first-line
treatment of advanced liver cancer (hepatocellular carcinoma, HCC).
Enno Spillner, Chief Executive Officer of 4SC AG, said: 'We very much
appreciate that our partner Yakult Honsha has started developing
resminostat in NSCLC. After HCC and CRC, this is now the third solid cancer
indication in which our new epigenetic drug has been introduced into
clinical evaluation. Lung cancer is the leading cause of cancer-related
mortality around the world, so we are excited to follow the development of
resminostat in yet another indication of both high medical need and large
market potential.'
Bernd Hentsch, Chief Development Officer of 4SC AG, added: 'There is
intriguing evidence in the literature that inhibition of histone
deacetylases (HDACs) may be effective in the treatment of lung cancer.
Although many drugs have been tested in NSCLC, the medical need in this
indication is still very high due to the heterogeneity of this group of
cancers and its relative insensitivity to standard chemotherapy regimens.
Therefore, the combination approach applied in this study again attempts to
make use of the so far observed good ability of resminostat to be combined
with a variety of other standard anti-tumor agents.'
Ends
About non-small-cell lung cancer (NSCLC)
Lung cancer is accounting for more than any other cancer deaths in men and
women worldwide. NSCLC is the most common type of lung cancer, accounting
for more than 85% of lung cancer cases. Despite advances in the treatment
of the disease and declining death rates over the last years in lung
cancer, outcomes remain poor for NSCLC patients. Most patients are treated
with surgery, either alone or in combination with chemotherapy, since NSCLC
is usually not very sensitive to chemotherapy and/or radiation. The most
popular drugs used for the treatment of NSCLC are targeting angiogenesis or
the epidermal growth factor receptor (EGFR). Patients with a more advanced
disease are primarily treated with a platinum based chemotherapy.
About resminostat
Resminostat (4SC-201), 4SC's lead oncology compound, is an oral
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 in 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 to date has been investigated in a broad clinical campaign
comprising liver cancer (hepatocellular carcinoma, HCC), Hodgkin's Lymphoma
(HL), and colorectal cancer (CRC), with non-small-cell lung cancer (NSCLC)
now adding a third solid cancer indication to the programme.
In the Phase II SAPHIRE trial in patients with advanced Hodgkin's Lymphoma
(HL), resminostat in monotherapy has demonstrated substantial anti-tumour
activity, with an overall response rate of 34% and a clinical benefit in
54% of the patients in a heavily pre-treated patient population together
with very good safety and tolerability. 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 8.1 months, a value to the company's best
knowledge not reached in any study with a comparable second-line patient
population. The resminostat/sorafenib combination therapy had shown a
progression-free survival rate (PFSR) after 12 weeks of 70.0% and a median
PFS of 5.4 months. The primary study endpoint was achieved ahead of
schedule in both the combination and the monotherapy group. Furthermore, in
the Phase I dose escalation part of the SHORE study, which has evaluated
resminostat in combination with the chemotherapeutic FOLFIRI regimen in
advanced CRC patients, positive results for safety and tolerability as well
as promising signs of clinical activity of this combination has been
published at the 2013 ASCO conference.
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 in a pivotal programme in first-line HCC
towards market approval.
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 product sales of
resminostat. Yakult Honsha will be responsible for all clinical
requirements for resminostat development in Japan in 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 cancer and autoimmune 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 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 and biotech companies. Founded in 1997, 4SC had 83
employees at 30 June 2013. 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.: +49-89-7007-6366
MC Services
Raimund Gabriel
raimund.gabriel(at)mc-services.eu , Tel.: +49-89-2102-2830
The Trout Group (USA)
Chad Rubin
Crubin(at)troutgroup.com, Tel.: +1-646-378-2947
End of Corporate News
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25.07.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
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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.comInternet: 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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