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Chi-Med Initiates FRESCO-2, a Global Phase III Trial of Fruquintinib in Metastatic Colorectal Cancer

Written by Customer Service on . Posted in Public Companies.

HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Sept. 04, 2020 (GLOBE NEWSWIRE) — Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) has initiated FRESCO-2, a Phase III registration study of fruquintinib for the treatment of patients with metastatic colorectal cancer (“CRC”) in the U.S., Europe and Japan. The first patient was dosed on September 3, 2020, in the U.S.FRESCO-2 is a randomized, double-blind, placebo-controlled, multicenter trial being conducted in patients with metastatic CRC. The primary endpoint of the study is overall survival. This large phase III trial will be enrolled in approximately 130 sites in 10 countries. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04322539.The U.S. Food and Drug Administration (“FDA”) granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020.  Clinical data including the completed Phase III FRESCO study in Chinese patients and this FRESCO-2 global study, if positive, would support a future New Drug Application (NDA) for the treatment of patients with advanced metastatic CRC (third-line and above), 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). About CRC

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