Updated on 23 March 2015
HUYA Bioscience International (HUYA) has completed the first cohort in a Phase 1 clinical trial in Japan of its cancer drug HBI-8000, a novel oral histone deacetylase (HDAC) inhibitor.
This follows acceptance by the Pharmaceutical and Medical Devices Agency (PMDA) of the company's accelerated development strategy in Japan.
The Phase 1 open-label, dose escalation trial is evaluating the safety and pharmacokinetics of HBI-8000 in Japanese patients with non Hodgkin's lymphoma. The first cohort received HBI-8000 tablets twice weekly, with no dose-limiting toxicities observed. The second cohort is now underway with a higher dose.
The trial is designed to establish a maximum tolerated dose (MTD) to proceed to Phase 2 trials for the treatment of adult T-cell leukemia/lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) in Japan.
The clinical development of HBI-8000 in Japan leverages clinical data from Chinese clinical trials through the Tripartite Cooperation on Health between China, South Korea and Japan.