Emergent BioSolutions Initiates Phase 1b Study of TRU-016 in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
“Preclinical studies have shown increased anti-tumor activity for the
combination of TRU-016 and rituximab beyond the levels achieved when
either drug was administered alone,” said
The Phase 1b, single-arm, open label study is enrolling approximately 24 previously untreated CLL patients and will evaluate the safety and efficacy of TRU-016 (an anti-CD37 biologic) in combination with rituximab (an anti-CD20 biologic). The primary outcome measurement for this study is overall response rate. Patients will receive TRU-016 and rituximab intravenously for six months. The company expects to complete enrollment in this study in 2013 and present data in the second half of 2013.
TRU-016 is also being evaluated in an ongoing Phase 2 study (protocol
16201) in combination with bendamustine for patients with relapsed CLL.
This study is designed to evaluate the safety and efficacy of TRU-016 in
combination with bendamustine compared with bendamustine alone. The
primary endpoint for the Phase 2 study is an overall response rate as
defined by 2008
Additional information about the Phase 1b study, as well as the ongoing Phase 2 study in combination with bendamustine in relapsed CLL, can be found on www.clinicaltrials.gov.
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Source:
Emergent BioSolutions Inc.
Robert G. Burrows, 301-795-1877
Vice
President, Investor Relations
BurrowsR@ebsi.com
or
Tracey
Schmitt, 301-795-1800
Vice President, Corporate Communications
SchmittT@ebsi.com