Safety committee raises concern over ArQule's liver cancer drug
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)
- Air strike kills 15 civilians in Yemen by mistake: officials
- North Korea executes leader's powerful uncle in rare public purge |
- Twitter backtracks on block feature after users revolt
- Insight: In Yemen, al Qaeda gains sympathy amid U.S. drone strikes
- Iran angry over U.S. sanctions, nuclear talks interrupted