BioCentury
ARTICLE | Clinical News

TRU-016: Phase Ib amended

April 15, 2013 7:00 AM UTC

Emergent amended an open-label, U.S. Phase Ib trial evaluating IV TRU-016 given weekly for 8 weeks followed by 4 monthly doses plus rituximab to include 2 additional cohorts of 16 patients each. Patients in the cohorts will receive 6 m/kg TRU-016 for the first dose and 10 mg/kg thereafter. One of the new cohorts will evaluate the combination as front-line treatment of CLL, while the other cohort will evaluate the combination in relapsed CLL patients. The trial initially planned to enroll about 24 previously untreated patients to receive 10 mg/kg TRU-016 for the first dose and 20 mg/kg thereafter. Emergent said the additional cohorts were included to test whether the lower dose will be as efficacious as the higher dose and was not due to any safety issues. TRU-016 is in Phase II testing to treat relapsed CLL and Phase Ib testing for non-Hodgkin's lymphoma (NHL). The compound has Orphan Drug designation in the U.S. and EU for CLL. ...