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Emergent BioSolutions Inc. (NYSE: EBS) announced today that three abstracts on its humanized anti-CD37 mono-specific protein therapeutic, TRU-016, and bispecific protein therapeutics have been accepted for presentation at the Annual Meeting of the American Society of Hematology (ASH) on December 8-11, 2012 in Atlanta, Georgia. The data accepted for presentation include results from a Phase 1b study evaluating TRU-016 in combination with bendamustine in patients with relapsed chronic lymphocytic leukemia (CLL). Results from this study concluded that TRU-016 in combination with bendamustine was well tolerated and showed a positive response.
“We are very encouraged by the TRU-016 data accepted for presentation at ASH this year,” said Scott C. Stromatt, M.D., Senior Vice President and Chief Medical Officer, Emergent BioSolutions. “We believe that TRU-016’s novel design and synergistic properties could provide a differentiated treatment option in combination with other therapies. We look forward to the results of our ongoing Phase 2 TRU-016 CLL study in combination with bendamustine which we expect in the second half of 2013.”
POSTER: Phase 1b Study of TRU-016, an Anti-CD37 SMIPTM Protein, in Combination with Bendamustine vs. Bendamustine Alone in Relapsed Chronic Lymphocytic LeukemiaDate:Saturday, December 8, 2012Presentation Time:5:30 PM – 7:30 PMLocation:Georgia World Congress Center, Hall B1-B2
Patients in the Phase 1b CLL combination study (16201) had 1-3 prior treatments (without prior treatment with bendamustine) and received either 15mg/kg or 20 mg/kg of TRU-016 weekly by intravenous (IV) infusion for two 28-day cycles, then every 14 days for four 28-day cycles. TRU-016 is a novel humanized anti-CD37 SMIP™ (mono-specific protein therapeutic). Bendamustine was administered on days one and two of each cycle by IV infusion for up to six 28-day cycles. Twelve patients were enrolled and treated – six patients at each dose level.