Emergent Biosolutions Inc (EBS)

[mlkrborn]

EBS $13.50 expand front line CLL clinical trial of TRU-016 and rituximab based on strong patient enrollment and encouraging early clinical data (EBS) .
Emergent BioSolutions to expand front line CLL clinical trial of TRU-016 and rituximab based on strong patient enrollment and encouraging early clinical data (EBS) 13.41 : Co 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 co's humanized anti-CD37 monospecific protein therapeutic, built on its ADAPTIRTM (Modular Protein Technology) platform, for the treatment of CLL. The co anticipates that this expanded clinical program will significantly enhance the value of TRU-016 and the company's active partnering program without impacting the company's total 2013 operating expenses.

TRU-016 is also currently being evaluated in a randomized, open label, active-controlled Phase 2 study in combination with bendamustine in patients with relapsed CLL. This study is on track to achieve its target enrollment of approximately 60 patients in April 2013.