4SC AG — Regulatory Filings 2012

Jun 15, 2012

News Details

Corporate | 15 June 2012 07:33

Press Release: 4SC to present biomarker data for cancer drug Resminostat from Phase II trial in Hodgkin’s lymphoma

4SC AG / Key word(s): Miscellaneous

15.06.2012 / 07:33

---

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, OR ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF APPLICABLE LAWS OR REGULATIONS

Press Release

4SC to present biomarker data for cancer drug Resminostat from Phase II SAPHIRE trial in Hodgkin's lymphoma at EHA Meeting in Amsterdam

Planegg-Martinsried, Germany – 15 June 2012 – 4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, will today present data of a set of biomarkers and their possible utility for stratification of patient populations analysed in the clinical Phase II SAPHIRE study with its anti-cancer compound resminostat in patients with relapsed/refractory Hodgkin's lymphoma (HL) at the 17 th Congress of the European Hematology Association (EHA) in Amsterdam, The Netherlands from 14-17 June 2012.

The poster will be presented at the Hogdin's lymphoma session today, Friday, 15 June 2012, from 5:45-7:00 pm (CEDT) and will report new data on the correlation of resminostat plasma levels and its pharmacodynamic effect on a set of biomarkers, including HDAC enzyme inhibition and the level of critical plasma proteins such as TARC. Furthermore, based on expression analysis of a set of marker genes regulated by resminostat, the identification and potential of certain gene expressions to serve as either additional pharmacodynamic markers or to qualify as biomarkers for patient stratification or prediction of clinical response to resminostat will be discussed.

Dr. Bernd Hentsch, Chief Development Officer, commented: 'Our biomarker analysis program has resulted in the identification of novel gene expressions that may serve as tools for the identification of those HL patients who could have a higher chance of obtaining a clinical benefit from resminostat treatment. This approach now opens the opportunity to target resminostat therapy more effectively to this patient group. Furthermore, we are applying this biomarker program to all our target indications, including HCC and CRC, in order to also explore possible stratification opportunities for those patients.'

The final efficacy data of the SAPHIRE study evaluating resminostat monotherapy in relapsed and/or refractory Hodgin's lymphoma patients had been presented at last year's ASH conference. The study met the primary efficacy endpoint with an overall response rate (ORR) of 35.3% and a clinical benefit in 55.9% of these heavily pretreated patients together with a very clean safety and tolerability profile. The open-label, single-arm, international study evaluated safety, pharmacokinetics, biomarkers, and efficacy of resminostat monotherapy treatment in 34 patients with advanced HL. Patients enrolled in the trial had either relapsed after high dose chemotherapy and/or autologous stem cell transplantation (ASCT) or had become refractory to treatment, and had on average received 6 prior treatments.

From today, 15 June 2012, 5:45 pm (CEDT), the detailed findings presented at the EHA meeting can also be downloaded at http://www.4sc.de/product-pipeline/publications-posters/resminostat .

Ends

Details of the Presentation:

Presentation Title: 'Efficient HDAC inhibition and TARC reduction in patients with refractory Hodgkin's lymphoma treated with Resminostat. PK/PD data from the Phase II SAPHIRE study'

Session date and time: Friday, 15 June 2012, 5:45 PM (CEDT)

Session name: Hodgkin's lymphoma

Authors/Presenters: J. Walewski 1 , G. Borsaru 2 , A. Moicean 3 , A.Hellmann 4 , A. Janikova 5 , B. Hauns 6 , A. Mais 6 , A. Ammendola 6 , T. Herz 6 , H. Kohlhof 6 , S.W. Henning 6 , B. Hentsch 6

1 Department of Lymphoid Malignancies, Maria Skłodowska-Curie Memorial Institute and Oncology Centre, Warszawa, Poland;

2 Clinical Hospital Coltea, Bucharest, Romania;

3 Center of Hematology & Bone Marrow Transplantation, Bucharest, Romania;

4 Department for Hematology & Transplantology, University Clinical Centre, Medical University of Gdansk, Gdansk, Poland;

5 Department of Internal Medicine, Hematology & Oncology, University Hospital Brno, Brno, Czech Republic;

6 4SC AG, Martinsried, Germany

About the SAPHIRE Trial Design

The SAPHIRE trial included HL patients that had relapsed after high dose chemotherapy and/or autologous stem cell transplantation (ASCT) or had become refractory to treatment. The study was designed as an open-label, single-arm, international trial consisting of two recruitment stages according to the Simon's Minimax design. Resminostat has been administered orally at a once daily dose of 600 mg during the 1st recruitment stage and due to its good tolerability at a higher daily dose of 800 mg in the 2nd stage. Patients were treated in 14-day cycles of five consecutive days followed by a nine-day treatment-free period (5+9 schedule). Patients underwent assessment of their disease status by computed tomography in combination with positron emission tomography (PET/CT) after Cycle 3 and Cycle 6 and thereafter every fourth cycle during an optional follow-up period in which patients could continue treatment until disease progression. The primary endpoint of the study was defined as the overall objective response rate (ORR) based on the best objective response during treatment. Secondary endpoints included time to response (TTR), duration of response (DOR), progression free survival (PFS), overall survival (OS), safety and tolerability and the evaluation of drug regulated biomarkers including the assessment of TARC levels as well as gene and protein expression profiling.

About Hodgkin's Lymphoma

Hodgkin's lymphoma (HL) is a cancer of the lymphatic system, which is part of the immune system, and leads to the abnormal growth of lymphatic cells that compromise the immune system's ability to fight infection. The disease can however also spread beyond the lymphatic systems to other organs. The main causes for the development of HL are still unknown. Recent research shows that this tumour originates from a degenerated lymphatic cell, the B lymphocyte. The incidence of HL in 2008 was 11,777 new cases in Europe and 8,220 new cases in the US. The age distribution is bimodal; the first peak occurs between the ages of 15 and 30 years and the second in the seventh decade.

HL is effectively treatable in the majority of cases. However, not all patients respond to current standard therapy strategies and available treatments for this disease can have significant long-term toxicity. Therapy options for HL patients depend on the stage of the disease and number and regions of lymph nodes affected. The first treatment line for HL, after the initial diagnosis, consists of chemotherapy and/or radiation, achieving cure rates of up to 80%. Standard of care for patients with refractory or relapsing disease after initial therapy consists of a salvage therapy comprising a conventional chemotherapy regimen usually followed by stem cell mobilization and subsequent high-dose chemotherapy along with autologous stem cell transplantation. Patients relapsing after second line therapy have a 5-year overall survival rate of only 17% (Source: Sirohi et al., Ann.Oncol., 2008). Since there is no standard of care in patients with relapsed/refractory HL, there is an especially high need to develop novel therapies for these patients.

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 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' to other anti-cancer compounds. This process can suppress or reverse certain tolerance mechanisms which tumour cells often develop against such 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 radiologically proven disease progression under first-line sorafenib therapy. According to the data presented at the ASCO annual meeting on 4 June 2012, resminostat / sorafenib combination therapy showed 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 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

End of Corporate News

---

15.06.2012 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@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

- - -
174100  15.06.2012