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4SC AG. (3/1/12). "Press Release: 4SC Receives Patent Protection for Its Oncology Compound Resminostat in Taiwan and Three other Asian Growth Markets". Planegg-Martinsried.
|Organisation 2||Yakult Honsha Co., Ltd.|
|Group||Yakult Honsha (Group)|
|Product 2||cancer drug|
|Person||Dauer, Ulrich (Omeicos 2010504– Managing Director (CEO) before Activaero + 4SC + Tripos)|
- 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
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.'
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 ®) 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.
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:
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
raimund.gabriel(at)mc-services.eu , Tel.: +49 (0) 89 21 02 28 30
mareike.mohr(at)mc-services.eu, Tel.: +49 (0) 89 21 02 28 40
The Trout Group (USA)
Crubin(at)troutgroup.com, Tel.: +1 646 378 2947
Record changed: 2012-05-06
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