Reuters: Hot Stocks: Safety committee raises concern over ArQule's liver cancer drug

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Safety committee raises concern over ArQule's liver cancer drug Sep 3rd 2013, 13:33 Sept 3 | Tue Sep 3, 2013 9:33am EDT Sept 3 (Reuters) - Drugmaker ArQule Inc said a late-stage trial of its liver cancer drug showed high incidence of low white blood cell count in patients, leading to an independent safety committee recommending the company lower the drug dose. ArQule shares fell nearly 20 percent to $2.24 on the Nasdaq in early morning trade on Tuesday. The Data Monitoring Committee recommended that the study dose be reduced from 240 mg twice daily to 120 mg, and the patients be monitored to confirm the safety profile of the lower dose. ArQule and its partner Daiichi Sankyo Inc accepted the recommendation of the committee and will file a protocol amendment with regulatory authorities, ArQule said in a regulatory filing. The companies were testing the drug, tivantinib, as a treatment for hepatocellular cancer - the most common type of liver cancer. The companies said they were unable to comment on whether the timeline for recruitment of the trial might be delayed from original estimates as a result of the proposed change and the subsequent data review, as the study was in the early stages of recruitment. (Reporting by Esha Dey in Bangalore; Editing by Kirti Pandey)

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