(Sharecast News) - Hutchison China MediTech, trading as Chi-Med, said on Friday that it has initiated 'FRESCO-2' - a phase 3 registration study of 'fruquintinib' for the treatment of patients with metastatic colorectal cancer (CRC) in the US, Europe and Japan.
The AIM-traded firm said the first patient was dosed on 3 September in the US.
It described FRESCO-2 as a randomised, double-blind, placebo-controlled, multicentre trial being conducted in patients with metastatic CRC.
The primary endpoint of the study was overall survival.
It said the large phase 3 trial would be enrolled in about 130 sites in 10 countries.
"The US Food and Drug Administration (FDA) granted fast track designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June," the board said in its statement.
"Clinical data including the completed phase 3 FRESCO study in Chinese patients and this FRESCO-2 global study, if positive, would support a future new drug application for the treatment of patients with advanced metastatic CRC, based on our agreement with the FDA.
"The FRESCO-2 study design was also reviewed and endorsed by the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)."
At 1409 BST, shares in Hutchison China MediTech were up 0.36% at 509.81p.
Hutchmed (HCM)3 May 2024 13:37