Emergent BioSolutions to Expand Front Line CLL Clinical Trial of TRU-016 and Rituximab Based on Strong Patient Enrollment and Encouraging Early Clinical Data
Published: Apr 05, 2013
ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE: EBS) today announced its decision to expand the protocol for its ongoing Phase 1b, single arm, open label study (Protocol 16009) evaluating the safety and efficacy of TRU-016 in combination with rituximab in previously untreated patients with chronic lymphocytic leukemia (CLL). The expanded protocol will include two new study cohorts to examine a lower dose of TRU-016 with rituximab in front line CLL and to evaluate the combination in relapsed CLL patients. This decision is based on strong patient enrollment along with encouraging early safety and efficacy data from this study. TRU-016 is the company’s humanized anti-CD37 monospecific protein therapeutic, built on its ADAPTIRTM (Modular Protein Technology) platform, for the treatment of CLL.