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ARTICLE | Clinical News

Birinapant: Phase Ib/IIa halted

May 25, 2015 7:00 AM UTC

TetraLogic temporarily halted enrollment in a double-blind, placebo-controlled, Australian Phase Ib/IIa trial of IV birinapant following observed cranial nerve palsies in 2 of the 7 patients in the first cohort receiving the 1.4 mg/m 2 weekly dose. The company did not disclose a timeline for next steps in the HBV indication but said its ongoing cancer trials are not affected. The trial is evaluating multiple ascending doses of birinapant once weekly for 4 weeks in combination with once-daily oral Viread tenofovir or entecavir in about 48 patients. TetraLogic said cranial nerve palsies are a known side effect but have occurred at a rate of about 5% at a dose >=22 mg/m 2 given weekly. ...