Emergent BioSolutions Inc. (EBS) announced that it has decided 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 or CLL.
The company said that 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.
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.
The company 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. The primary outcome measurement for this study is overall response rate. Results from the Phase 1b portion of this study, presented at the American Society of Hematology annual meeting on December 8, 2012, indicated that TRU-016 in combination with bendamustine was well tolerated and showed an NCI overall response rate of 83% with a CR rate of 33% (n=12).
The company expects that data from both TRU-016 clinical trials will be available in the second half of 2013. TRU-016 has received Orphan Drug status from the FDA and Orphan Medicinal Product Designation from the European Commission for the treatment of CLL.
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