Golden Biotechnology Corp.(TW4132) received the Russian MoH approval letter on January 16, 2019 for the implementation in Russia to perform Phase 2 clinical trial of acute myeloid leukemia (AML). This is a phase 2 open-label, non-randomized clinical trial of Antroquinonol in patients with AML. The given pilot clinical trial of a medicinal product for medical use, is held to evaluate preliminary efficacy and safety/tolerability profiles of antroquinonol in adult patients with relapsed AML or at initial diagnosis when no intensive treatment is possible.
The new drug Antroquinonol (Hocena) is a small molecule new drug for the treatment of cancers including acute myeloid leukemia and other diseases. In addition to the human clinical trial of acute myeloid leukemia in Russia, the company will do its utmost to complete the development and clinical efficacy of Antroquinonol in other indications.
Antroquinonol has been granted orphan drug designation for the treatment of acute myeloid leukemia (AML),pancreatic cancer and HCC(Hepatocarcinoma,Liver cancer) by US FDA as well as pancreatic cancer by EU EMA.