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27.05.2016 15:44:00
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DGAP-Ad hoc: 4SC AG
DGAP-Adhoc: 4SC AG: 4SC provides headline results from Yakult Honsha's Phase II trial of resminostat in combination with sorafenib as first line therapy in liver cancer
In April 2011, 4SC has 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. After successfully completing a Phase I safety study with resminostat in Japanese patients with advanced solid tumors in May 2014, Yakult Honsha initiated the Phase I/II study in patients with HCC, a cancer with high medical need and very limited therapeutic options, which has a particularly high incidence in Japan.
In the Phase II part in 170 Asian patients with advanced HCC, resminostat in combination with sorafenib as first-line therapy in HCC did not meet the primary endpoint of statistically significant prolonged time to disease progression (TTP) compared to sorafenib monotherapy. Based on the result of the Phase II part, Yakult Honsha will not conduct a pivotal study of resminostat/sorafenib combination as first-line treatment of HCC in all- comer patients.
However, patients with high expression levels of the ZFP64 biomarker at baseline seem to have longer TTP in the sorafenib/resminostat combination therapy when compared with sorafenib monotherapy.
Yakult Honsha is now analyzing the results in more detail. Other ongoing as well as planned clinical trials, and in particular 4SC's anticipated Phase II CTCL trial in the EU, will not be affected.
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Information and Explanation of the Issuer to this News:
About Resminostat
Resminostat is an HDAC (histone deacetylase) inhibitor administered in tablet form with an innovative epigenetic mechanism of action. The compound has already been clinically tested for treating Hodgkin's lymphoma as well as liver, lung, colon, pancreatic, and biliary tract cancer. In new preclinical models, resminostat further showed promising anti-cancer and immunomodulatory activity.
About liver cancer (liver cell carcinoma, hepatocellular carcinoma, HCC)
With around 748,000 new cases each year, liver cancer is the fifth most common type of cancer worldwide and the third most frequent tumor-related cause of death. In the past three decades alone, the number of new cases has almost doubled. Liver cancer often remains undetected until it reaches an advanced stage, resulting in only a slim chance of recovery. The tyrosine kinase inhibitor sorafenib is the only approved drug-based first- line therapy for patients with advanced liver cancer which has been shown to offer a survival benefit in clinical trials.
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 EUR 6 million and is eligible for up to approximately EUR 127 million payable upon achieving specified milestones including clinical and regulatory events in Japan. In addition to milestone payments, Yakult Honsha 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.
About 4SC
4SC (www.4sc.com) is a biotechnology company dedicated to the research and development of small-molecule drugs focused on epigenetic mechanisms of action for the treatment of cancers with high unmet medical needs. These drugs are intended to provide innovative treatment options for cancer patients that are more tolerable and efficacious than existing therapies, provide a better quality of life and offer increased life expectancy. 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 pharmaceutical and biotech companies. Founded in 1997, 4SC had 50 employees at 1 May 2016. 4SC has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
Forward-looking information
This press release contains certain forward-looking statements. Any forward-looking statement applies only on the date of this press release. By their nature, forward-looking statements are subject to a number of known and unknown risks and uncertainties that may or may not occur in the future and as a result of which the actual results and performance may differ substantially from the expected future results or performance expressed or implied in the forward looking statements. No warranties or representations are made as to the accuracy, achievement or reasonableness of such statements, estimates or projections, and 4SC AG has no obligation to update any such information or to correct any inaccuracies herein or omission herefrom which may become apparent.
Contact
4SC AG Corporate Communications & Investor Relations Wolfgang Güssgen, wolfgang.guessgen@4sc.com, +49 89 700763-73 Dr. Anna Niedl, anna.niedl@4sc.com, +49 89 700763-66
MC Services Katja Arnold, katja.arnold@mc-services.eu, +49 89 210228-40
The Ruth Group Carol Ruth, cruth@theruthgroup.com, +1 646 536 7004
27.05.2016 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap.de
--------------------------------------------------------------------------- Language: English Company: 4SC AG Am Klopferspitz 19a 82152 Planegg-Martinsried Germany Phone: +49 (0)89 7007 63-0 Fax: +49 (0)89 7007 63-29 E-mail: public@4sc.com Internet: www.4sc.com ISIN: DE000A14KL72 WKN: A14KL7 Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange End of Announcement DGAP News-Service ---------------------------------------------------------------------------
4SC AG / Key word(s): Study results
27.05.2016 15:44
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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4SC provides headline results from Yakult Honsha's Phase II trial of
resminostat in combination with sorafenib as first line therapy in liver
cancer
Planegg-Martinsried, Germany, 27 May 2016 - 4SC AG (4SC, FSE Prime
Standard: VSC) today announced that its Japanese partner Yakult Honsha Co.,
Ltd. (Yakult Honsha) has completed the randomized Phase II part of a
clinical Phase I/II study which evaluates 4SC's epigenetic cancer compound
resminostat in combination with the cancer drug sorafenib as a potential
novel first-line therapy of Asian patients in Japan and South Korea with
advanced liver cancer (hepatocellular cancer, HCC).
In April 2011, 4SC has 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. After successfully completing a Phase I safety study with resminostat in Japanese patients with advanced solid tumors in May 2014, Yakult Honsha initiated the Phase I/II study in patients with HCC, a cancer with high medical need and very limited therapeutic options, which has a particularly high incidence in Japan.
In the Phase II part in 170 Asian patients with advanced HCC, resminostat in combination with sorafenib as first-line therapy in HCC did not meet the primary endpoint of statistically significant prolonged time to disease progression (TTP) compared to sorafenib monotherapy. Based on the result of the Phase II part, Yakult Honsha will not conduct a pivotal study of resminostat/sorafenib combination as first-line treatment of HCC in all- comer patients.
However, patients with high expression levels of the ZFP64 biomarker at baseline seem to have longer TTP in the sorafenib/resminostat combination therapy when compared with sorafenib monotherapy.
Yakult Honsha is now analyzing the results in more detail. Other ongoing as well as planned clinical trials, and in particular 4SC's anticipated Phase II CTCL trial in the EU, will not be affected.
---------------------------------------------------------------------------
Information and Explanation of the Issuer to this News:
About Resminostat
Resminostat is an HDAC (histone deacetylase) inhibitor administered in tablet form with an innovative epigenetic mechanism of action. The compound has already been clinically tested for treating Hodgkin's lymphoma as well as liver, lung, colon, pancreatic, and biliary tract cancer. In new preclinical models, resminostat further showed promising anti-cancer and immunomodulatory activity.
About liver cancer (liver cell carcinoma, hepatocellular carcinoma, HCC)
With around 748,000 new cases each year, liver cancer is the fifth most common type of cancer worldwide and the third most frequent tumor-related cause of death. In the past three decades alone, the number of new cases has almost doubled. Liver cancer often remains undetected until it reaches an advanced stage, resulting in only a slim chance of recovery. The tyrosine kinase inhibitor sorafenib is the only approved drug-based first- line therapy for patients with advanced liver cancer which has been shown to offer a survival benefit in clinical trials.
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 EUR 6 million and is eligible for up to approximately EUR 127 million payable upon achieving specified milestones including clinical and regulatory events in Japan. In addition to milestone payments, Yakult Honsha 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.
About 4SC
4SC (www.4sc.com) is a biotechnology company dedicated to the research and development of small-molecule drugs focused on epigenetic mechanisms of action for the treatment of cancers with high unmet medical needs. These drugs are intended to provide innovative treatment options for cancer patients that are more tolerable and efficacious than existing therapies, provide a better quality of life and offer increased life expectancy. 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 pharmaceutical and biotech companies. Founded in 1997, 4SC had 50 employees at 1 May 2016. 4SC has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
Forward-looking information
This press release contains certain forward-looking statements. Any forward-looking statement applies only on the date of this press release. By their nature, forward-looking statements are subject to a number of known and unknown risks and uncertainties that may or may not occur in the future and as a result of which the actual results and performance may differ substantially from the expected future results or performance expressed or implied in the forward looking statements. No warranties or representations are made as to the accuracy, achievement or reasonableness of such statements, estimates or projections, and 4SC AG has no obligation to update any such information or to correct any inaccuracies herein or omission herefrom which may become apparent.
Contact
4SC AG Corporate Communications & Investor Relations Wolfgang Güssgen, wolfgang.guessgen@4sc.com, +49 89 700763-73 Dr. Anna Niedl, anna.niedl@4sc.com, +49 89 700763-66
MC Services Katja Arnold, katja.arnold@mc-services.eu, +49 89 210228-40
The Ruth Group Carol Ruth, cruth@theruthgroup.com, +1 646 536 7004
27.05.2016 The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap.de
--------------------------------------------------------------------------- Language: English Company: 4SC AG Am Klopferspitz 19a 82152 Planegg-Martinsried Germany Phone: +49 (0)89 7007 63-0 Fax: +49 (0)89 7007 63-29 E-mail: public@4sc.com Internet: www.4sc.com ISIN: DE000A14KL72 WKN: A14KL7 Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange End of Announcement DGAP News-Service ---------------------------------------------------------------------------
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