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news.Emergent BioSolutions, a developer, manufacturer and commercializer of vaccines and antibody therapies, has started an open-label, multi-centre, active-controlled Phase Ib/II study to assess B-cell malignancies treatment TRU-016.
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The company expects to recruit around 114 bendamustine-naive patients with a confirmed diagnosis of relapsed CLL and who have failed up to three previous treatments.
In the Phase Ib portion of the trial, the company will evaluate the safe and tolerable dose of TRU-016 in conjunction with bendamustine in up to 14 patients with relapsed CLL.
However, the Phase II portion of the trial will investigate the efficacy and safety aspect of TRU-016 in conjunction with bendamustine compared with standalone bendamustine treatment in a total of 100 randomized patients.
Emergent chief scientific officer James Jackson said given the strong TRU-016 preclinical combination data, and the positive clinical results from the single agent dose escalation study, they believe human clinical evaluation of TRU-016 in combination with bendamustine could yield meaningful results.
"The dose escalation study in CLL continues to demonstrate that TRU-016 is well tolerated and clinically active and we look forward to Phase I combination data from this study, as well as the planned Phase I combination study for follicular Non-Hodgkin’s Lymphoma," Jackson said.