4SC AG / Key word(s): Miscellaneous
06.09.2011 07:30
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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- Resminostat shows substantial clinical benefit in heavily pre-treated
relapsed/refractory HL Patients -
Planegg-Martinsried, Germany, 6 September, 2011 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune diseases and cancer, today announced positive
topline data from its Phase II SAPHIRE trial with resminostat, its oral pan
HDAC inhibitor, in patients with relapsed/refractory Hodgkin's Lymphoma
(HL). Resminostat monotherapy exhibited substantial anti-tumour activity,
including complete and partial tumour responses. Analysis of tumour
response assessments revealed that the study achieved its primary endpoint.
Furthermore the study verified the drug to be safe and well tolerated in
this advanced stage patient population.
In June 2011 the SAPHIRE trial completed patient enrolment. 33 patients
have been evaluated for tumour response which, according to the study
protocol, represents the targeted number of patients required for efficacy
analyses. Central assessment of patient tumour data by an independent
expert review board revealed objective tumour responses in 11 patients,
constituting a 33.3% overall response rate (ORR) and thereby successfully
achieving the pre-defined requirements of the primary endpoint of the
study. An additional 7 patients achieved stabilization of their disease and
thus a clinical benefit as well. The ORR of 33.3% together with the
clinical benefit recorded in total for 54.5% of the patients (disease
control rate) demonstrates the substantial anti-tumour activity of
resminostat monotherapy in an advanced and heavily pre-treated Hodgkin's
Lymphoma patient population for which there is currently no established
standard therapy available. Prior to study entry, the patients enrolled
received a median of 6 treatments consisting of various chemo- and
radiation therapies including autologous stem cell transplantation in 57%
of the cases.
Final data from this trial, including secondary endpoints, will be
presented at an upcoming international scientific conference.
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Information and Explaination of the Issuer to this News:
Conference Call & Webcast
The senior management team of 4SC will host a conference call and webcast
at 3pm CET (9am EST) today to inform about the topline results of the
SAPHIRE study.
Access to the presentation slides can be obtained at:
http://4sc060911-live.cyber-presentation.de
Participants can access the conference under the following telephone
numbers:
Date: 6 September, 2011
Time: 3pm CET (9am EST)
Dial-in numbers:
0800 10 12 072 (Germany)
0800 358 0886 (UK)
1 877 941 1469 (USA)
+49 (0) 6103 485 3001 (other countries)
Conference-ID: 4470246
Approximately two hours after the live presentation, an audio replay will
be available on the 'investors' section of the homepage www.4sc.com.
About 4SC
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 a number of factors.
For further information, please visit www.4sc.com or contact:
4SC AG
Jochen Orlowski, Investor Relations & Public Relations
jochen.orlowski@4sc.com
Tel.: +49 (0) 89 70 07 63 0
Bettina v. Klitzing-Stückle, Corporate Communications
bettina.von.klitzing@4sc.com
Tel.: +49 (0) 89 70 07 63 0
MC Services (Europe)
Raimund Gabriel
raimund.gabriel@mc-services.eu
Tel.: +49 (0) 89 21 02 28 30
The Trout Group (USA)
Chad Rubin
Crubin@troutgroup.com
Tel.: +1 646 378 2947
06.09.2011 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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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@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 Announcement DGAP News-Service
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DGAP-Adhoc: 4SC's Resminostat Meets Primary Efficacy Endpoint in Phase II Trial in Hodgkin's Lymphoma (HL)
| Source: EQS Group AG