4SC AG has announced that the first patient has been treated in a Japan-based Phase I clinical study with 4SC's cancer drug resminostat.
The open-arm, dose-escalating study is being conducted by Yakult Honsha, 4SC's Japanese co-development and marketing partner.
The study will evaluate safety and tolerability of resminostat in Japanese patients with advanced solid tumours. It will furthermore investigate the drug's efficacy, pharmacokinetics and pharmacodynamics.
The development of resminostat in the Japanese market is of high strategic importance to 4SC for two reasons.
In April 2011, 4SC 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.
Hepatocellular carcinoma (HCC), the most common type of liver cancer with a high medical need and only few available therapeutic options has a particularly high incidence in Japan. HCC is one of the cancer indications targeted with resminostat in advanced clinical development.
Dr. Ulrich Dauer, Chief Executive Officer of 4SC AG, said: 'We are very pleased that our Japanese partner Yakult Honsha has started the clinical development of resminostat in Japan. This is of high relevance for both our alliance with Yakult in Japan and the further development strategy for resminostat in this important market. The primary goal of the study is to prove that the drug is safe and well tolerated in Japanese patients, which is a key prerequisite for resminostat's further development in this region. We are currently in discussions with regulatory authorities and potential partners to prepare for a global pivotal clinical study programme with resminostat in patients with advanced liver cancer (HCC). Given the high incidence of HCC in Japan and the whole of Asia, gaining market approval in this region is a key goal for us.'