BioCentury
ARTICLE | Clinical News

ArQule off on higher incidence of neutropenia with tivantinib

September 4, 2013 12:39 AM UTC

ArQule Inc. (NASDAQ:ARQL) slid $0.30 (11%) to $2.49 on Tuesday after disclosing that a DMC recommended reducing the dose of tivantinib in the Phase III METIV-HCC trial to treat inoperable hepatocellular cancer (HCC) due to a higher incidence of neutropenia than was seen with the compound in a Phase II trial in the indication. The DMC also recommended that ArQule institute "enhanced patient monitoring procedures," including increased attention to neutropenia incidence and neutrophil counts, to confirm the safety of the lower dose. ArQule and partner Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) have an SPA from FDA for the trial, which is slated to enroll about 300 patients. ...