Emergent BioSolutions Announces Acceptance of Four TRU-016 Abstracts for Presentation at 2011 American Society of Hematology Annual Meeting
“The data accepted for presentation at ASH this year continue to provide
supporting evidence that TRU-016 could be a viable option for patients
suffering from B-cell malignancies,” said
POSTER: Phase 1 Study of TRU-016, An Anti-CD37 SMIP™ Protein
in Naive and Relapsed and/or
Refractory CLL Patients
Publication
#1792
Patients in the Phase 1 TRU-016 CLL study received 12 doses of either 10, 20 or 30 mg/kg of TRU-016 administered intravenously weekly for two months followed by three monthly doses. Patients treated in the dose escalation portion of the study were eligible for rollover retreatment in the expanded cohort.
Twenty-six patients (7 naïve, 16 relapsed/refractory, and 3 rollover) received TRU-016 in the expanded cohort with 12 patients in active follow up at the time of abstract submission. Lymphocyte reduction of ≥50% was observed in 81% (17/21) of naïve and relapsed/refractory CLL patients and 33% (1/3) in rollover CLL patients. Lymph node reduction of ≥50% as measured by CT scan was observed in 46% (6/13) of the patients. The overall response rate was 86% (6/7 partial response) in naïve CLL patients and 17% (3/17 partial response) in relapsed/refractory CLL patients. Responses in relapsed CLL patients were limited to those with 1-2 prior treatments as previously observed in the dose escalation phase of the study, for a response rate of 33% (3/9).
There were three subjects with dose limiting toxicities; none occurred more than once in a dose cohort. A maximum tolerated dose was not identified. The most frequent Grade 3/4 adverse events were infection (4 patients), neutropenia (3 patients) and febrile neutropenia (2 patients). There were nine serious adverse events reported by four patients, with two patients having events considered possibly related to TRU-016.
POSTER: Phase 1 Study of TRU-016, An Anti-CD37 SMIP™ Protein
in Relapsed and/or Refractory
NHL Patients
Publication
#1636
Pre-clinical in vitro and in vivo models of
Sixteen highly-refractory and heavily-pretreated
Lymphocyte reduction of ≥50% was observed in 25% (4/16) of the patients.
Lymph node reduction of ≥50% as measured by CT scan was observed in 18%
(2/11) of the patients. One follicular
The most frequent Grade 3/4 adverse events were neutropenia (6 patients) and thrombocytopenia (2 patients). There were no Grade 3/4 infections reported. There were 2 serious adverse events reported by 2 patients, both were considered unrelated to TRU-016 by the investigators.
The single-agent clinical activity of TRU-016, and the synergistic or
additive effect of TRU-016 with multiple agents demonstrated in
pre-clinical models, warrant a combination trial of TRU-016, which has
been initiated with bendamustine and rituximab in relapsed indolent
B-cell
Additional TRU-016 abstracts accepted for presentation at ASH 2011 include:
ORAL PRESENTATION: Tetraspanin CD37 Directly Mediates
Transduction of Survival and
Apoptotic Signals
Publication
#622
POSTER: Pro-Apoptotic Effect of an Anti-CD37 Scfv-Fc Fusion
Protein, in Combination with the
Anti-CD20 Antibody,
Ofatumumab, on Tumor Cells from B-Cell Malignancies
Publication
#1662
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Emergent BioSolutions Inc.
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Robert G.
Burrows, 301-795-1877
Vice President, Investor Relations
BurrowsR@ebsi.com
or
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Tracey
Schmitt, 301-795-1800
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SchmittT@ebsi.com