EMA recommends 4SC's resminostat for orphan medicinal product designation to treat HL

Oct 13 2011

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 European Medicines Agency (EMA) has recommended 4SC's anti-cancer compound resminostat for designation as orphan medicinal product for the treatment of Hodgkin's Lymphoma (HL), a cancer of the lymphatic system. EMA's orphan medicinal product designation includes a ten-year period of market exclusivity from the date of approval in the European Union (EU) and allows direct access to a centralized marketing authorization and fee reductions. Resminostat, 4SC's lead oncologic compound, already received in July 2011 a positive opinion for orphan medicinal product designation in the EU in the indication hepatocellular carcinoma (HCC), the most common type of liver cancer. Furthermore, resminostat recently obtained orphan drug status in the US for HCC and HL.

As recently reported, in the Phase II SAPHIRE study as a third-line treatment in relapsed/refractory HL patients, resminostat showed a 33.3% overall response rate and a general clinical benefit in 54.5% of patients, demonstrating positive anti-tumour-efficacy and very good tolerability. Furthermore 4SC had published in June 2011 positive interim data from its Phase II SHELTER study with resminostat in HCC patients. The oral pan HDAC inhibitor resminostat is, in addition to evaluation in HL and HCC, currently also being studied in a phase I/II trial in patients with colorectal cancer (CRC).

Dr. Ulrich Dauer, CEO of 4SC commented: 'We are delighted that the EMA has recommended our lead oncology compound resminostat for designation as orphan medicinal product also in Hodgkin's Lymphoma (HL). Based on the positive data from our Phase II SAPHIRE study in HL and on the results of our Phase II SHELTER study in HCC, which are anticipated by the end of this year, we plan to discuss the next development steps with regulatory authorities and potential partners. Consequently we expect the next step to be the planning of a pivotal development programme, especially considering the high medical need and the limited therapeutic options available in the indications addressed with resminostat.'

Source: 4SC